RENAFLO II HEMOFILTER

Report

Report Number: 2150060-2022-00003
Event Type: Death
Date Received: January 6, 2022
Date of Event: September 24, 2021
Report Date: January 6, 2022
Manufacturer: MEDIVATORS, INC.
Product Code: KDI
UDI-DI: 00677964000089
PMA / PMN Number: K923312
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

BLOOD LOSS WAS CONFIRMED AS A RESULT OF THE FILTER LEAK; HOWEVER, THE ESTIMATED VOLUME OF BLOOD LOSS IS NOT KNOWN. THE FULL MEDICAL HISTORY FOR THE PATIENT SUBJECT OF THE EVENT WAS NOT DISCLOSED TO MEDIVATORS. HOWEVER, IT WAS REPORTED THAT THE PATIENT HAD PRE-EXISTING CONDITIONS, INCLUDING RENAL FAILURE, AND WAS IN THE ICU AT THE TIME OF THE HEMOFILTRATION PROCEDURE. THE REPORTED FILTER SUBJECT OF THE LEAK IS NOT ABLE TO BE RETURNED FOR EVALUATION. A BATCH RECORD REVIEW WAS PERFORMED WHICH INDICATED THAT THE BATCHES OF FILTERS AND FIBERS FOR THE REPORTED FILTER LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. NO NONCONFORMITIES WERE IDENTIFIED DURING THE MANUFACTURING, STERILIZATION AND ENDOTOXIN TESTING, AND A 100% VISUAL INSPECTION FOR LEAK TESTING WAS PERFORMED WITHOUT EXCEPTION. THE INVESTIGATION OF THIS EVENT REMAINS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

Description of Event or Problem · 0

(B)(4), A DISTRIBUTOR OF MEDIVATORS HEMOFILTERS, REPORTED THAT DURING A HEMOFILTRATION PROCEDURE INVOLVING THE MEDIVATORS HF1200 HEMOFILTER, A FILTER LEAK OCCURRED. A SECOND FILTER WAS PREPPED TO BE EXCHANGED IN ORDER TO CONTINUE THE PROCEDURE. DURING THE PREPARATION OF THE SECOND FILTER, THE PATIENT EXPIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1170290	RENAFLO II HEMOFILTER	HIGH PERMEABILITY DIALYSIS SYSTEM	KDI	MEDIVATORS, INC.	93024-132	481877	00677964000089

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Death