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

Model Number	DD+ELISIO-17H
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Clinic stated that they have experienced an increase in clotted dialyzers since switching from optiflux dialyzers to elisio dialyzers.Treatments are interrupted, and most are unable to return the patient's blood.The clotting is not patient, dialyzer size, or user specific.3 total incidents: (b)(6) 2021 - 1 incident, (b)(6) 2021 - 1 incident, (b)(6) 2021 - 1 incident.Clinical specialist contacted the facility and offered in-person product training for (b)(6) 2021.Clinic was advised to follow ifu for proper priming instructions, because the staff was following clinic protocols and not the product ifu.After our clinical specialist visited the clinic and observed the staff during priming and recirculating process, it was identified that the clinic was recirculating with 100ml instead of 200ml as instructed in the ifu.Arterial chambers were also observed not be be 75% full in some cases.During her visit to the clinic, the nurse manager advised that a patient required a blood transfusion 2 days after treatment was interrupted and the patient's blood could not be returned due to the clotted dialyzer.All data was documented and an email with her findings was sent to the nurse manager, providing instructions for proper priming, recirc, and levels of bloodline chambers.Initial date of occurence is unknown.Clinic stated the first incident occurred sometime in (b)(6).Dialzyer size was later received (b)(6) 2021.
Event or Problem Description
Clinic stated that they have experienced an increase in clotted dialyzers since switching from optiflux dialyzers to elisio dialyzers.Treatments are interrupted, and most are unable to return the patient's blood.The clotting is not patient, dialyzer size, or user specific.3 total incidents: (b)(6) 2021: 1 incident; (b)(6) 2021: 1 incident; (b)(6) 2021: 1 incident.Clinical specialist contacted the facility and offered in-person product training for (b)(6) 2021.Clinic was advised to follow ifu for proper priming instructions, because the staff was following clinic protocols and not the product ifu.After our clinical specialist visited the clinic and observed the staff during priming and recirculating process, it was identified that the clinic was recirculating with 100ml instead of 200ml as instructed in the ifu.Arterial chambers were also observed not be 75% full in some cases.During her visit to the clinic, the nurse manager advised that a patient required a blood transfusion 2 days after treatment was interrupted and the patient's blood could not be returned due to the clotted dialyzer.All data was documented and an email with her findings was sent to the nurse manager, providing instructions for proper priming, recirc, and levels of bloodline chambers.Initial date of occurence is unknown.Clinic stated the first incident occurred some time in february.Dialzyer size was later received (b)(6) 2021.

• Brand Name: NIPRO ELISIO-H DIALYZERS
• Common Device Name: 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: 11898967
• Report Number: 9610987-2021-00006
• Device Sequence Number: 3755081
• Product Code: KDI
• UDI-Device Identifier: 00383790007115
• UDI-Public: 00383790007115
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K131935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 06/09/2021

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: 01/31/2022
• Device Model Number: DD+ELISIO-17H
• Device Catalogue Number: DD+ELISIO-19H
• Device Lot Number: 19B04A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 06/09/2021
• 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