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 2016-06-29 for DIALOG + 120 V DF+ADIMEA+WAN-BSL 710200S manufactured by B. Braun Avitum Ag - Melsungen.
[48510535]
(b)(4). Customer originally reported that during therapy with the dialog+ dialysis machine ((b)(4)), a patient had an excess ultrafiltration of approximately 1. 5 kg. (patient 2, occurence 1). Customer biomed further indicated that he ran a mock therapy, which did not show any deviations related to ultrafiltration. After a follow up call with the facility to request additional information about the incident, the customer biomed indicated that the patients did leave dialysis below target weight twice (0. 3 to 0. 6 kg below target) with no other treatment issues before or after. Based on the biomed's report, it is believed that these incident were related to a patient weighing issue, which was being addressed with the nursing team. (b)(4) braun technician also visited your facility to service the machine. During this inspection he found a bicarbonate conductivity sensor with a hairline crack in the flange which connects it to the dialysis fluid block. The sensor was replaced, all applicable checks were completed and the machine was released for service. All information associated with this event was forwarded to (b)(4) (manufacturer) for further evaluation. Also submitted for evaluation was the replaced sensor and the machine trend file. Based on their investigation, the manufacturer confirmed that the data showed that during the therapy the alarm "uf balance? Air leakage in dialyz. Coupl. " (alarm code 1026) was triggered. The alarm was acknowledged by the user and the therapy was continued. The trend data evaluation corresponds to the hairline crack found in the flange of the conductivity sensor. In case of a crack, air leaks into 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 and replaced by fluid from outside the balance circuit. After the 10th opening of the valve, the alarm "uf balance? Air leakage in dialyz. Coupl. " (alarm code 1026) is triggered as described. As part of the investigation, the manufacturer ran three mock therapies with the returned conductivity sensor with an ultrafiltration volume set at 1000 ml. The actual ultrafiltration results were 991 to 1028 ml, which is well within tolerance. The manufacturer concludes that based on the results of the mock therapies performed by customer biomed and the (b)(4) technician, the incidents of ultrafiltration are independent from the hairline crack found in the conductivity sensor. Furthermore, the entire case was reviewed by a nephrologist and based on his assessment, the cramping of the patient is attributed to the lowered dry weight, which was confirmed by the facility biomed. The reported ultrafiltration deviations can be attributed to factors independent from dialysis as for example weighing errors, which was also confirmed by the facility biomed as a potential cause. Although, the incident in this case does not appear to have been caused by the cracked conductivity sensor, the manufacturer has initiated a recall on the dialog machine related to cracks in the conductivity sensors, which can potentially cause uf deviations in patient therapy. 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. 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. (b)(4). If additional pertinent becomes available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[48510536]
As reported by the user facility: machine ran two therapies and displayed the alarm uf imbalance alarm. Both patients had over filtration of approximately 1. 5 k. Both patients were cramping and administered saline. Simulated therapy run with no issues by trained technician. Additional information from customer (b)(6) 2016 by e-mail: upon further investigation , we were unable to come up with any documentation of what was reported in the original complaint. We found that one patient had a cramping episode while on the machine in question and saline was given. However, the patient's dry weight had just been lowered and there were no issues before or after that incident. Another patient did leave below their dry weight twice but was only. 3 to. 6 under on those occasions with no other treatment issues before or after. At this time it is believed to be a patient weighing issue and it is being addressed with the teammates and patient education is also ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002879653-2016-00021 |
| MDR Report Key | 5760279 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-06-29 |
| Date of Report | 2016-06-01 |
| Date of Event | 2016-05-30 |
| Date Facility Aware | 2016-05-31 |
| Report Date | 2016-06-29 |
| Date Reported to FDA | 2016-06-29 |
| Date Reported to Mfgr | 2016-06-29 |
| Date Mfgr Received | 2016-06-01 |
| Date Added to Maude | 2016-06-29 |
| 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 |
| Generic Name | HAEMODIALYSIS SYSTEM |
| Product Code | FKJ |
| Date Received | 2016-06-29 |
| Catalog Number | 710200S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-06-29 |