MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 210H; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 955610

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Malaise (2359); Palpitations (2467); Low Oxygen Saturation (2477)

Event Date 02/21/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during treatment with a polyflux 210h set, the patient felt sick, experienced a blood pressure decrease, palpitations and decreased oxygen saturation.It was reported 21 minutes after starting treatment the patient experienced palpitations and a blood pressure (bp) reading of 64/27mmhg.It was reported the oxygen saturation (sp02) was decreased to 92%.The patient was administered 3l oxygen therapy and began treatment with effortil in normal saline, risumic and metligine (no further details).It was reported the patient¿s legs were elevated and the patient was monitored on an electrocardiogram.Seventeen minutes later, hd therapy was discontinued.Treatment was restarted with a non-baxter dialyzer.The patient recovered and was released home.It was reported this was a first time use with the polyflux dialyzer.No additional information is available.

• Brand Name: POLYFLUX 210H
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• Manufacturer (Section G): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; holger - crafoord - strasse 26; hechingen D-723 79; GM D-72379
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8683356
• MDR Text Key: 147478544
• Report Number: 9611369-2019-00074
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K043342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2019

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 Catalogue Number: 955610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 06/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NIPRO FIX 190E; NIPRO NCV-3
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 83