MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 17L; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 102058

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

Patient Problems Hyperventilation (1910); Rash (2033); Swelling (2091)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during treatment with a polyflux 17l dialyzer, the patient presented allergic reactions (drop in blood pressure, rash, swelling at the neck, breathlessness).No other baxter products (machine or solutions) were being used at the time of the event.Further treatment information was not provided.The outcome of the patient was not reported.No additional information is available.

Manufacturer Narrative

Udi: (b)(4).B5 - the patient received fenistil and solu-decortin h intravenous, which was reported to have quickly improved symptoms.Treatment was continued without further issues after the administration of the drugs.The extracorporeal circuit was returned to the patient at the end of treatment.The patient was reported to have completely recovered.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 17L
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 7487282
• MDR Text Key: 107377371
• Report Number: 9611369-2018-00049
• Device Sequence Number: 1
• Product Code: KDI
• 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: 06/08/2018

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: 12/31/2020
• Device Catalogue Number: 102058
• Device Lot Number: 8-4301-H-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 05/04/2018
• Supplement Dates Manufacturer Received: 05/24/2018
• Supplement Dates FDA Received: 06/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR