MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER 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 Edema (1820); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

I was reported that a hemodialysis patient using a polyflux 14l dialyzer experienced angioedema, hypotension and urticarial rashes 5 minutes into treatment.It was reported that the bloodline and dialyzer were flushed with 700ml of normal saline and circulated with dialysate fluid for at least 10 minutes with pump speed of 200-250mls/min before the start of dialysis treatment.The treatment was discontinued with blood restitution.The patient was treated with adrenaline 0.5mgx2 im (intra-muscular), intravenous hydrocortisone 200mg, normal saline fluid challenge, blood investigation and intra-nasal oxygen.Most of the symptoms were resolved the following day, except for some residual swelling.No additional information is available.

Manufacturer Narrative

The device was not received for evaluation; therefore, a device analysis could not be completed.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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 - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 7819286
• MDR Text Key: 118316519
• Report Number: 9611369-2018-00083
• 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: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 109651
• Device Lot Number: 8-5112-H-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention