DIALOG A + HE/BIC 710200L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-04-20 for DIALOG A + HE/BIC 710200L manufactured by B. Braun Avitum Ag - Melsungen.

Event Text Entries

[43174157] (b)(4). Customer biomed reported that machine sn (b)(4) had uf balance air in dialyzer alarm during therapy. According to the report, the facility biomed inspected the machine and found small crack in the biclf sensor (item# (b)(4)). All information associated with this event was forwarded to b. Braun (b)(4) for further evaluation. Also submitted for evaluation was the replaced component. 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)(4). Action taken to prevent recurrence of problem: b. Braun (b)(4) has initiated (b)(4). B. Braun (b)(4) has initiated (b)(4). If additional pertinent becomes available, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[43174158] As reported by the user facility: customer reported a cracked conductivity sensor causing auf balance alarm. No patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002879653-2016-00006
MDR Report Key5588147
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2016-04-20
Date of Report2015-12-16
Date of Event2015-12-02
Date Facility Aware2015-12-16
Report Date2016-04-19
Date Reported to FDA2016-04-19
Date Reported to Mfgr2016-04-19
Date Mfgr Received2015-12-16
Date Added to Maude2016-04-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS IRIS RATKE
Manufacturer StreetBUSCHBERG 1
Manufacturer CityMELSUNGEN, 34212
Manufacturer CountryGM
Manufacturer Postal34212
Manufacturer Phone661713718
Manufacturer G1B. BRAUN AVITUM AG - MELSUNGEN
Manufacturer StreetSCHWARZENBERGER WEG 73-79
Manufacturer CityMELSUNGEN, D-34212
Manufacturer CountryGM
Manufacturer Postal CodeD-34212
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDIALOG A + HE/BIC
Generic NameHAEMODIALYSIS SYSTEM
Product CodeFKJ
Date Received2016-04-20
Catalog Number710200L
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN AVITUM AG - MELSUNGEN
Manufacturer AddressSCHWARZENBERGER WEG 73-79 MELSUNGEN, D-34212 GM D-34212


Patients

Patient NumberTreatmentOutcomeDate
10 2016-04-20

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