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

Model Number	DD+CT17H
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Dyspnea (1816); Syncope/Fainting (4411)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Charge rn stated that cellentia was primed with 250 ns and patient treatment started.Within 5 minutes of treatment start, patient complained of feeling faint and short of breath.Charge nurse stated that they stopped the treatment and did not return blood to patient.Staff reported that no medications were given to the patient and the patient vital signs were stable.Patient requested to go to the emergency room and ambulance was called.Patient was discharged from hospital and returned to the outpatient clinic on wednesday (b)(6) 2022 at which time she had a dialysis treatment using cellentia dd again and completed the treatment without any complaints.Patient has been using cellentia 17 dialyzers for a year now and this is the first time she complained of problems.
Event or Problem Description
Charge rn stated that cellentia was primed with 250 ns and patient treatment started.Within 5 minutes of treatment start, patient complained of feeling faint and short of breath.Charge nurse stated that they stopped the treatment and did not return blood to patient.Staff reported that no medications were given to the patient and the patient vital signs were stable.Patient requested to go to the emergency room and ambulance was called.Patient was discharged from hospital and returned to the outpatient clinic on wednesday (b)(6) 2022 at which time she had a dialysis treatment using cellentia dd again and completed the treatment without any complaints.Patient has been using cellentia 17 dialyzers for a year now and this is the first time she complained of problems.

• 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: 15431374
• Report Number: 9610987-2022-00007
• Device Sequence Number: 4621878
• Product Code: KDI
• UDI-Device Identifier: 00383790004398
• UDI-Public: 00383790004398
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: DD+CT17H
• Device Catalogue Number: DD+CT17H
• Device Lot Number: 22A20D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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