MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH UNKNOWN- 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: 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 leak occurred during treatment.The dialyzer in use was a hemoflow hf 80 s from batch a2bi21100.The complaint sample was not available.The estimated blood loss (ebl) volume is unknown.No additional information could be obtained.

Manufacturer Narrative

Correction.

• Brand Name: UNKNOWN- 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 str. 6-8; st. wendel 66606 ; GM 66606
• MDR Report Key: 11101939
• MDR Text Key: 227351212
• Report Number: 3002807005-2020-00007
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• 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: 12/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1