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

Model Number	DD+CT17H
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
2hours and 30 minutes into hemodialysis treatment, machine alarmed.Treatment stopped, blood leak confirmed with blood leak test strip.No visible blood on dialyzer.Blood was not returned, undetermined amount of blood loss, estimated minimal.No medical interventions or hospitalization.Priming conditions: bfr=150ml/min and priming volume=1000ml.Dialysis conditions: tx time=3hrs, bfr=350ml/min, dfr=sequential (uf only), access= avf with 16g needle 1".
Event or Problem Description
2hours and 30 minutes into hemodialysis treatment, machine alarmed.Treatment stopped, blood leak confirmed with blood leak test strip.No visible blood on dialyzer.Blood was not returned, undetermined amount of blood loss, estimated minimal.No medical interventions or hospitalization.Priming conditions: bfr=150ml/min and priming volume=1000ml.Dialysis conditions: tx time=3hrs, bfr=350ml/min, dfr=sequential (uf only), access= avf with 16g needle 1.

• Brand Name: NIPRO CELLENTIA-H DIALYZER
• 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
• 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, FL 33172 ; 3055997174
• MDR Report Key: 15573241
• Report Number: 9610987-2022-00008
• Device Sequence Number: 2781374
• Product Code: KDI
• UDI-Device Identifier: 00383790004398
• UDI-Public: 00383790004398
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160444
• 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): 12/02/2022

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: 11/30/2024
• Device Model Number: DD+CT17H
• Device Catalogue Number: DD+CT17H
• Device Lot Number: 21L16C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown