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: the majority of all reported leaks show detachment of the potting compound.Around the world, there are no known problems with the hemoflow f 8 hps; it appears to be a local problem.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.

Event Description

It was reported that a leak occurred with several filters during treatment.The dialyzer(s) used were hemoflow f 8 hps from batch z2bh23100.A complaint sample was not available.The estimated blood loss (ebl) volume is unknown.No additional information could be obtained.

Manufacturer Narrative

Correction: labeled for single use.

• 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: 11101892
• MDR Text Key: 228356341
• Report Number: 3002807005-2020-00006
• 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