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

Model Number DD+ELISIO-17H

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 04/28/2020

Event Type  malfunction  

Event Description

Clinic staff noticed a dialyzer blood leak.At the start of treatment, circuit filled with blood to just prior to venous chamber, had high pressure alarms as one needle clotted.Placed in circulation while needle pulled, hemostasis achieved.Once recannulated, machine taken out of circulation and treatment started (in circulation ~10minutes) blood leak alarm within seconds of restarting treatment.Patient was set up on alternate machine and completed treatment.Patient will be given prophylactic antibiotics.Other devices used: fresenius 5008, left bc avf, bloodline - compatible w/fresenius 5008 double needle, #15g wingeater (jms) needles.

Event Description

Clinic staff noticed a dialyzer blood leak.At the start of treatment, circuit filled with blood to just prior to venous chamber, had high pressure alarms as one needle clotted.Placed in circulation while needle pulled, hemostasis achieved.Once recannulated, machine taken out of circulation and treatment started (in circulation ~10 minutes) blood leak alarm within seconds of restarting treatment.Patient was set up on alternate machine and completed treatment.Patient will be given prophylactic antibiotics.Other devices used: fresenius 5008, left bc avf, bloodline - compatible w/fresenius 5008 double needle, #15g wingeater (jms) needles.

• Brand Name: NIPRO ELISIO-H DIALYZER
• Type of Device: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, nilda-aza; ohdate-shi, akita, 01857 94; JA 0185794
• MDR Report Key: 10083905
• MDR Text Key: 240725557
• Report Number: 9610987-2020-00003
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00383790007115
• UDI-Public: 00383790007115
• Combination Product (y/n): N
• PMA/PMN Number: K131935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: DD+ELISIO-17H
• Device Catalogue Number: DD+ELISIO-19H
• Device Lot Number: 19J07A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other