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

Model Number DD+ELISIO-25H

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemolysis (1886)

Event Date 05/26/2023

Event Type  malfunction  

Event Description

4 hours and 2 minutes into dialysis treatment, machine alarmed for blood leak.There was no visible blood in the dialyzer.Machine was tested for blood leak, test strip confirmed leak.Incident occurred twice.Same patient.Patient's blood was not returned and machine was pulled from floor per facility policy.Facility primed at 250ml with 150 priming speed.Confirmed all machine calibrations were within manufacturer specifications.Patient returned to their next dialysis treatment without further issues.

Manufacturer Narrative

Initial investigation report attached is on retained samples only.

Manufacturer Narrative

Initial investigation report attached is on retained samples only.

Event Description

4 hours and 2 minutes into dialysis treatment, machine alarmed for blood leak.There was no visible blood in the dialyzer.Machine was tested for blood leak, test strip confirmed leak.Incident occurred twice.Same patient.Patient's blood was not returned and machine was pulled from floor per facility policy.Facility primed at 250ml with 150 priming speed.Confirmed all machine calibrations were within manufacturer specifications.Patient returned to their next dialysis treatment without further issues.

• Brand Name: NIPRO ELISIO-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
• Manufacturer (Section G): NIPRO CORPORATION (ODT); 8-7, hanuki-yachi, niida-aza; ohdate-shi, akita 018-5 794; JA 018-5794
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami 33172 ; 3055997174
• MDR Report Key: 17227491
• MDR Text Key: 318117180
• Report Number: 9610987-2023-00002
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2023

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 Model Number: DD+ELISIO-25H
• Device Lot Number: 22F16E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 06/02/2023
• Supplement Dates FDA Received: 07/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other