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 customer reported the failure with "medical event" for one filter of hf80s/ batch b2bc16100 during treatment.The following investigation tasks have been performed: a 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 and trending review of relevant capas.The described situation is adequately addressed in the ifu and/or on the label and the product deficiency is not related to falsification.The complaint sample was not available and no meaningful pictures were attached so further analysis could not be performed.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.Batch record investigation was performed.25.608 products have been inspected according to the inspection protocol and 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.Complaint history review for affected product and product family was performed.One further complaint regarding the batch was received.The described situation is covered in the risk analysis.

Event Description

It was reported that a hemodialysis machine gave an alarm and high tmp was observed a few minutes after the initiation of hemodialysis treatment.The nurse immediately found that there was coagulation in the dialyzer product number hf80s batch b2bc16100.When priming the bloodline with normal saline, the dialyzer with 3-degree agglutination was found, and the dialyzer and bloodline were replaced.After the replacement of the dialyzer, the dialysis treatment was completed successfully.No harm occurred to the patient.The complaint sample was not available for return to the manufacturer for physical evaluation.The estimated blood loss (ebl) volume is unknown.No additional information could be obtained.

Manufacturer Narrative

Correction: date of event.

• 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
• MDR Report Key: 11101942
• MDR Text Key: 247703433
• Report Number: 3002807005-2020-00008
• 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

• 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
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 12/31/2020
• Supplement Dates FDA Received: 12/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1