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

Model Number	DD+CT21H
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Dyspnea (1816); Dysphasia (2195)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient attended regularly scheduled in-center dialysis treatment.Pre vital signs bp-149/82, pulse-101, respiration-21, temperature - 97.8.At approx 0954 dialysis was initiated with a use of treatment ended, patient given diphenhydramine 50 mg ivp(intravenous push).Patient developed shortness of breath, slurred speech and right facial droop.911 called, patient transported to hospital via ems(emergency medical services) and later released.Patient returned to facility (b)(6) 2023, treated on optiflux 180nr dialyzer without incident.Nipro cellentia 21 added as allergy.
Event or Problem Description
Patient attended regularly scheduled in-center dialysis treatment.Pre vital signs bp-149/82, pulse-101, respiration-21, temperature - 97.8.At approx 0954 dialysis was initiated with a use of treatment ended, patient given diphenhydramine 50 mg ivp(intravenous push).Patient developed shortness of breath, slurred speech and right facial droop.911 called, patient transported to hospital via ems (emergency medical services) and later released.Patient returned to facility (b)(6) 2023, treated on optiflux 180nr dialyzer without incident.Nipro cellentia 21 added as allergy.

• 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: 18388822
• Report Number: 9610987-2023-00005
• Device Sequence Number: 19526303
• Product Code: KDI
• UDI-Device Identifier: 00383790004411
• UDI-Public: 00383790004411
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2023

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: 11/30/2023
• Device Model Number: DD+CT21H
• Device Lot Number: 20L24D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/24/2020
• 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: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown