MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 170H; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 112466

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

Patient Problem Anaphylactic Shock (1703)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that 15 minutes into patient treatment with a polyflux 170h apac, the patient experienced an anaphylactic shock.Treatment was not reported.The patient outcome was not reported.No additional information is available.

Manufacturer Narrative

Additional information: g5, h3, h6 and h10.The actual device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of the provided pictures showed the product was disconnected from the patient and did not identify any abnormalities as only the label of the dialyzer was visible.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.As the actual device was not returned, the cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: POLYFLUX 170H
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; deerfield IL
• MDR Report Key: 9533664
• MDR Text Key: 188741609
• Report Number: 9611369-2019-00199
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414102760
• UDI-Public: (01)07332414102760
• 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: 01/24/2020

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: 01/31/2022
• Device Catalogue Number: 112466
• Device Lot Number: 9-4904-H-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other