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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number UNKNOWN- DIALYZER
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: the following investigation tasks have been performed: review of instruction for use (ifu) and/or label evaluation if product deficiency relates to falsification investigation/testing of returned, retained and/or reference samples review of batch documentation review complaint history / trending review of relevant capas. The described situation is adequately addressed in ifu and/or on the label and the product deficiency is not related to falsification. The complaint sample was not available. The provided picture confirms the reported failure. Due to 100% testing, it is highly unlikely to detect a failure in the retention sample. Furthermore, only a small number of reserve samples are available. Therefore the retention sample analysis is not done. The dialyzers are 100% tested for leaks with both bubble-point and air testing during sterilization. So a failure during the manufacturing process can be excluded. Due to a faulty storage or handling process detachments of the potting compound can occur. Batch record investigation (dhr): 20028 products have been inspected according to the inspection protocol, were found conforming to specifications, and have been released without any discrepancies. No indication for any relationship with the reported failure mode has been found during the review.
 
Event Description
It was reported there was a leakage on one filter of hemoflow f 8 hps / batch a2ba03100 during treatment. The leak was reported to be at the potting. The estimated blood loss (ebl) volume is unknown. No additional information could be obtained.
 
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Brand NameDIALYZER
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
st. wendel plant
frankfurter strabe 6-8
st. wendel 66606
GM 66606
Manufacturer (Section G)
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
st. wendel plant
frankfurter strabe 6-8
st. wendel 66606
GM 66606
Manufacturer Contact
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key11102035
MDR Text Key247702411
Report Number3002807005-2020-00011
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K002761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN- DIALYZER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received12/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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