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

Model Number	DD+ELISIO-17H
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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
• Common Device Name: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, nilda-aza; ohdate-shi, akita, 01857 94; JA 0185794
• MDR Report Key: 10083905
• Report Number: 9610987-2020-00003
• Device Sequence Number: 2848324
• Product Code: KDI
• UDI-Device Identifier: 00383790007115
• UDI-Public: 00383790007115
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/22/2020
• Supplement Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other