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.

• 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
• MDR Report Key: 17228058
• MDR Text Key: 318182748
• Report Number: 1056186-2023-00004
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/29/2023

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2023
• Distributor Facility Aware Date: 05/31/2023
• Device Age: 11 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/29/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other