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

Catalog Number UNKNOWN- DIALYZER

Device Problem Fluid/Blood 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.

• Brand Name: DIALYZER
• Type of Device: DIALYZER, 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 Key: 11102035
• MDR Text Key: 247702411
• Report Number: 3002807005-2020-00011
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- DIALYZER
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 12/08/2020
• 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
• Patient Sequence Number: 1