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 and no meaningful pictures were provided. 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. Although st. Wendel dialyzers are 100% tested for leaks (bubble-point testing and air testing during sterilization), leaks due to adverse environmental conditions or mechanical stress during treatment can occur in very few cases. A batch record investigation was performed and all product was found to be conforming to specifications, and released without any discrepancies. A cause for the reported failure mode could not be established.

Event Description

It was reported that a dialyzer blood leak occurred while using an f60s dialyzer from batch z1bg05100. Three minutes into treatment, the color of the dialysate port appeared pink. The complaint sample was not available. The estimated blood loss (ebl) volume is unknown. No additional information could be obtained.

• 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
• 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 Key: 11102353
• Report Number: 3002807005-2020-00015
• 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

• Device Catalogue Number: UNKNOWN- DIALYZER
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• 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