MAUDE Adverse Event Report: NIPRO CORPORATION (ODT) NIPRO CELLENTIA-H DIALYZER

Model Number DD+CT-C-17H, DD+CT-C-21H

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemolysis (1886)

Event Date 07/01/2022

Event Type  Injury  

Event Description

3x incident reports filed involved 3x different cellentia (2x 17h and 1x 21h) on the same patient.1st incident, 17h cellentia dialyzer - blood leak detected x2, confirmed by chem strip.Same patient, 2 different dialysis machines; 2nd incident) 21h cellentia dialyzer - blood leak.Details: patient began dialysis (after 1 l.Prime and at blood pump @ 420 ml/min) with cellentia 17h (lot# 21c08c) on a fresenius 5008 machine with bloodline code# 3vm5008r (lot# c3ym131).One hour into therapy the machine stopped due to blood leak detector alarm.Staff noted pink in dialysate effluent and confirmed blood with roche cobra hb strips at a reading of 5 grams/l.Dialysis was stopped, circuit discarded and patient moved to a different machine with different 17h filter same lot# and dialysis restarted.Almost immediately a blood leak detector alarm occurred and verified with hb test strips.The dialysis was stopped and circuit discarded.Moved to a third 5008 machine and this time a 21h filter (thinking they had bad batch of 17h) and same result, blood leak detector alarm.There is a note in patient history of an infusion of 20 mg of alteplaste used the previous week to unblock patient fistula.

• Brand Name: NIPRO CELLENTIA-H DIALYZER
• Type of Device: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODT); 8-7, hanuki-yachi, niida-aza; ohdate-shi, akita 018-5 794; JA 018-5794
• MDR Report Key: 15107856
• MDR Text Key: 296657717
• Report Number: 1056186-2022-00010
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DD+CT-C-17H, DD+CT-C-21H
• Device Lot Number: 21C08C, 19I12C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2022
• Distributor Facility Aware Date: 07/08/2022
• Device Age: 14 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other