MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION POLYFLUX 14L; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 109651

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

Patient Problems Distress (2329); Reaction (2414); Sweating (2444)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that within 20 minutes of treatment with a polyflux 140h dialyzer, the patient experienced dry cough, chest distress and cold sweat.It was reported ¿the patient was allergic to the dialyzer¿.Treatment was discontinued, and the patient received intravenous dexamethasone (10 mg).It was reported 30 minutes later the patient symptoms were in ¿remission¿ and the ¿patient is stable now¿.The dialyzer was replaced (different type, no further details) to continue treatment.No additional information is available.

Manufacturer Narrative

H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: POLYFLUX 14L
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9429322
• MDR Text Key: 185193436
• Report Number: 9611369-2019-00187
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414086633
• UDI-Public: (01)07332414086633
• Combination Product (y/n): N
• PMA/PMN Number: K043342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

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: 10/31/2021
• Device Catalogue Number: 109651
• Device Lot Number: 8-5227-H-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 12/16/2019
• Supplement Dates FDA Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR