MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-01-18 for DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC N/A 710200S manufactured by B. Braun Avitum Ag - Melsungen.
[36249503]
(b)(4). This report has been identified as b. Braun avitum internal report #(b)(4) (event 1). In a follow up with the facility, the reporter stated that after a review of the past treatments on the same machine, the machine showed signs of over-filtration. Machine was placed into a "minimum uf rate". The reporter stated that the machine did alarm and that he noticed build up on the connector which was giving a "bicarb not connected properly". The conductivity sensor was replaced and a mock therapy with the uf measurement done was performed "and the machine pulled off the right amount". The facility also reported that the machine is back in operation and confirmed that no medical intervention was required. The investigation is on-going at this time. A follow up report will be provided when the evaluation results are available.
Patient Sequence No: 1, Text Type: N, H10
[36249504]
As reported by the user facility: event 1: customer technician reported an overfiltration of a patient. In a follow up call with the facility they reported that a review of the past treatments on the same machine showed signs of over-filtration.
Patient Sequence No: 1, Text Type: D, B5
[41071866]
(b)(4). Customer technician reported that six (6) patients experienced ultrafiltration while treated with the above referenced dialog+ dialysis machine (refer to mdr report for each event). Event 1 (therapy on (b)(6) 2015): the amount of ultrafiltration experienced by the last patient was reported to be 1kg. The patient was hypotensive and complained about feeling bad. 700 ml saline and oxygen were administered. The technical inspection on-site showed a crack in the bicarbonate conductivity sensor. The sensor was exchanged, and the machine was released for use after testing. All available information, machine trend data and defective conductivity sensor were forwarded to the manufacturer, b. Braun (b)(4), for further evaluation. According to their investigation of the returned conductivity sensor they confirmed the described cracks in the area where the sensor is connected to the dialysis fluid block. The analysis of the trend data records of the complained dialog+ dialysis machine were consistent with the leakage of the conductivity sensor. This analysis showed that air accumulated in the air separator during therapy. The air was removed from the system by opening the valve vla. After the 10th opening of the valve the alarm "uf balance? Air leakage in dialyzer coupling" (alarm code 1026) was triggered. Per machine design requirements, in case of a crack of a conductivity sensor, air is sucked into the fluid system of the machine due to the negative pressure in this area. The air is collected in the air separator. If the air separator is filled, the air is released by opening the valve vla. After the 10th opening of the valve, the alarm described above is triggered. Since the air released from the air separator is replaced by fluid from outside the balance circuit, the accumulation of air due to a leaking conductivity sensor has no influence on the ultrafiltration accuracy as it has been demonstrated by laboratory tests. Thus, the manufacturer concludes that the balance deviation (over filtration) referenced by the customer was not caused by the leakage of the conductivity sensor. Since the machine operated as intended again after the replacement of the conductivity sensor, there is no evidence that the excess of ultrafiltration was due to a malfunction of the dialog+ dialysis machine. The cause of the described excess of ultrafiltration is not comprehensible. However, there are a number of causes not related to the dialysis machine which can potentially caused ultrafiltration. Hypotension and slight cramping are known side effects of the dialysis therapy and/or end stage renal failure. The trend investigation, the laboratory test and the result of the technical investigation by customer technician show no evidence for an over- or underfiltration due to a technical defect (leaking conductivity sensor) as described in this complaint. If additional pertinent information becomes available, a follow up report will be submitted. Although a crack in a conductivity sensor does not compromise the balance accuracy of the dialog+ dialysis machine, the manufacturer has initiated a (b)(4) to investigate the cause of the cracks in the conductivity sensors and to define measures to avoid this failure in the future.
Patient Sequence No: 1, Text Type: N, H10
[47803940]
(b)(4). Customer reported that six (6) patients experienced over filtration while treated with the dailog+ machine sn (b)(4). Regarding event #1, the customer reported that during a therapy the patient experienced over filtration. The amount of over filtration was reported to be 1kg. The machine was inspected by the biomed and he reported that he found a crack on the bicarbonate conductivity sensor (item# 3456102a). The sensor was replaced and the machine was released for use after testing. All information associated with this event was forwarded to b. Braun avitum (b)(4) (manufacturer) for further evaluation. Also submitted was the replaced sensor for evaluation. Based on their investigation, the manufacturer confirmed that the component had some cracks at the connection point to the df-block. The investigation indicates that during therapy there is negative pressure at the conductivity cells. So a leakage at this point leads to air being sucked into the fluid system of the device. Air sucked into the fluid system at this point is pumped through the dialysis fluid system until it reaches the air separator, where it is accumulated. If the air separator gets filled with air, the air is separated by opening the air separator valve vla. The openings of vla are counted, and after the 10th opening of this valve the alarm 1026 is triggered as mentioned: alarm text: "uf balance? Air leakage in dialyz. Coupl. " as a result of other reports associated with uf deviations, the manufacturer discovered that a limited number of flanges assembled into bicarbonate and end conductivity cells showed hairline cracks. As described above, the conductivity sensors are utilized in an area of the dialysis fluid system which is under negative pressure. The negative pressure allows air to be sucked into the dialysis fluid. The air collects in an air separator which forms part of the dialysis fluid system. When the air separator is filled, the air separator valve (vla) opens and the air is purged and replaced by dialysis fluid from outside the balance circuit. The leakage has different consequences dependant upon whether or not the dialog+ hemodialysis machine is equipped with a df-filter or not. In dialog machines with df-filter (option df-filter, hdf online machines) the air passes this filter on its way to the air separator. Since air blocks the filter it is flushed out during cyclic filter rinsing, collected in the air separator and flushed out as described. Continuous air entry due to the leakage of the conductivity cells can lead to cyclical pressure fluctuations due to excess air inside the df-filter, thus blocking it. This might lead to an excess uf for the patient ("excessive removal"). The maximum possible amount of the excess uf (theoretical worst case) caused by this failure type was determined in a laboratory setting artificially producing the maximum leakage at which the dialysis machine can be put in therapy. At a dialysis flow of 800 ml/min, the uf deviation was 636 ml/h with the alarm triggered after 55 min of therapy. In addition, 77 conductivity cells returned from the market and showing this failure type were investigated. 64 of these cells showed an uf deviation below 200 ml/h and 13 above 200 ml/h at a dialysis fluid flow of 800 ml/min. The maximum uf deviation measured in this case was 488 ml/h. In dialog machines without df-filter the air is also transported to the air separator, where it accumulates and is released as described above. Since there is no df-filter, in these devices no accumulating air might cause an excess uf. The air accumulated in the air separator expands when it is separated and substituted with dialysis fluid from outside the balance circuit. So the fluid volume is bigger than the volume of the compressed air and the uf volume is decreased. Therefore, in devices without df-filter air entry might lead to a too low ultrafiltration ("insufficient removal"). This mechanism occurs also in devices with df-filter but is superimposed by the described cyclical pressure fluctuations inside the df-filter. The amount of insufficient uf caused by this failure type in dialysis machines without df-filter was determined in the above mentioned theoretical worst case setting. The maximum uf deviation in this case was 250 ml/h at a dialysis fluid flow of 800 ml/min. The respective alarm was triggered for the first time after 13 min. To further investigate the uf deviation 24 conductivity cells returned from the market were tested. Three of these conductivity cells showed a deviation between 100 to 200 ml/h with a maximum at 148 ml/h, the other conductivity cells showed lower or no uf deviation. The tests showed that the uf deviations decreased with decreasing dialysis fluid flow. They also imply that the cracks at the conductivity cells develop and increase with time during continuous use of the device. With an increasing leakage, the amount of air sucked into the dialysis fluid system increases and the frequency of the opening of the vla valve. This means that the above described alarm starts to occur first towards the end of a therapy and occurs earlier and earlier with the growth of the crack. If the leakage might approach the maximum, the alarm is triggered early in therapy and more frequently. If the maximum is reached, follow-up alarms will stop the preparation or therapy phase. Root cause: the principle cause of failure of the product is due to variation in molding parameters of the flanges utilized in the construction of the conductivity sensors. Due to the variation in molding parameters, there is potential for thermal and mechanical stresses during normal operation to induce cracks in the conductivity sensors which causes the ingress of air into the dialysis fluid. Correction: b. Braun avitum (b)(4) (manufacturer) and (b)(4) (importer) have initiated an urgent medical device correction (recall) on april 1, 2016. Action taken to prevent recurrence of problem: b. Braun avitum (b)(4) (manufacturer) has initiated capa(b)(4). (b)(4) (importer) has initiated capa(b)(4). If additional pertinent becomes available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002879653-2015-00018 |
| MDR Report Key | 5374791 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-01-18 |
| Date of Report | 2015-12-28 |
| Date of Event | 2015-12-26 |
| Date Facility Aware | 2015-12-28 |
| Report Date | 2016-04-19 |
| Date Reported to FDA | 2016-04-19 |
| Date Reported to Mfgr | 2016-04-19 |
| Date Mfgr Received | 2015-12-28 |
| Date Added to Maude | 2016-01-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS IRIS RATKE |
| Manufacturer Street | BUSCHBERG 1 |
| Manufacturer City | MELSUNGEN, 34212 |
| Manufacturer Country | GM |
| Manufacturer Postal | 34212 |
| Manufacturer Phone | 661713718 |
| Manufacturer G1 | B. BRAUN AVITUM AG - MELSUNGEN |
| Manufacturer Street | SCHWARZENBERGER WEG 73-79 |
| Manufacturer City | MELSUNGEN, D-34212 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-34212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIALOG + 120 V DF+ADIMEA+WAN-BSL+BIC |
| Generic Name | HEMODIALYSIS SYSTEM |
| Product Code | FKJ |
| Date Received | 2016-01-18 |
| Model Number | N/A |
| Catalog Number | 710200S |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN AVITUM AG - MELSUNGEN |
| Manufacturer Address | SCHWARZENBERGER WEG 73-79 MELSUNGEN, D-34212 GM D-34212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-18 |