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

Model Number DD+CT17H

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Syncope/Fainting (4411)

Event Date 08/22/2022

Event Type  Injury  

Event 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 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
• Type of Device: 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
• MDR Text Key: 300031846
• Report Number: 9610987-2022-00007
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00383790004398
• UDI-Public: 00383790004398
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other