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

Model Number DD+CT21H

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Dysphasia (2195)

Event Date 10/09/2023

Event Type  Injury  

Event 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 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
• 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: 18388822
• MDR Text Key: 331283800
• Report Number: 9610987-2023-00005
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00383790004411
• UDI-Public: 00383790004411
• 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: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/24/2020
• 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): Hospitalization; Required Intervention; Other