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U.S. Department of Health and Human Services

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

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FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH UNKNOWN- 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: review of the instructions for use (ifu) and/or device label determined the described situation is adequately addressed. The complaint sample was not available. The provided picture confirmed 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 was not performed. St. Wendel dialyzers are 100% tested for leaks, by performing both bubble-point testing and air testing during sterilization. Poor storage and handling processes can result in detachments of the potting compound. A batch record investigation was performed and all product was found to be conforming to specifications, and released without any discrepancies.
 
Event Description
It was reported that a dialyzer blood leak occurred five minutes into a patient's treatment. The dialyzer in use was an f60s from batch b1bb14100. The complaint sample was not available. The estimated blood loss (ebl) volume is unknown. No additional information could be obtained.
 
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Brand NameUNKNOWN- DIALYZER
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
st. wendel plant
frankfurter str. 6-8
st. wendel 66606
GM 66606
Manufacturer (Section G)
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
st. wendel plant
frankfurter str. 6-8
st. wendel 66606
GM 66606
Manufacturer Contact
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key11102881
MDR Text Key247703219
Report Number3002807005-2020-00018
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,Followup
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 Received12/31/2020
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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