MAUDE Adverse Event Report: NIPRO CORPORATION (ODATE) NIPRO CELLENTIA DIALYZER

Model Number DD+CT19H

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)

Event Date 06/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

1 hour into dialysis treatment, the patient complained of itchiness and hives were noted on both lower and upper extremities and back.No benadryl was given and treatment was discontinued after 2 hrs of treatment, staff stated itchiness was better but redness still visible and patient was sent home.Patient will return on (b)(6) 2019 and will be put on rexeed dialyzer, which was the dialyzer she was previously using.The physician stated they will give the patient a week rest and will try again next thursday ((b)(6) 2019) on elisio dialyzer again but will prime the elisio with more saline (1.5 l), as they already prime the elisio 25h with 1 l of saline.Patient was given aranesp 40 mcg, hectorol 1 mcg and iron 125 mg during treatment, which are not new medications for her.Dialysis treatment order: patient dialyzed 3.5 hrs, bfr = 500, dfr = 800.Heparin with 1000 units bolus and 1000 units/hr stop 1 hr before end of treatment.Additional information received (b)(6) 2019: patient is doing good now with the elisio dialyzer, the staff is now priming with 1.5 l of saline and patient has not had any reactions during treatment.This is the same patient that had a reaction to elisio (b)(6) 2019 ((b)(4)).

• Brand Name: NIPRO CELLENTIA DIALYZER
• Type of Device: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, nilda-aza; ohdate-shi, akita, 01857 94; JA 0185794
• MDR Report Key: 8750954
• MDR Text Key: 149768603
• Report Number: 1056186-2019-00008
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00383790007139
• UDI-Public: 00383790007139
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: DD+CT19H
• Device Lot Number: 19D01C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2019
• Distributor Facility Aware Date: 06/06/2019
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other