MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX TPE; SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA

Catalog Number 107144

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/07/2021

Event Type  Death  

Manufacturer Narrative

The information in this mdr was initially submitted to the fda on 10/04/2021 through mdr 8010182-2021-00300.8010182-2021-00300 incorrectly indicated that the report was being submitted as an importer report.This mdr is being resubmitted to the fda as a manufacturer report and 8010182-2021-00300 is being closed as a duplicate of this mdr.Initial reporter phone number: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during therapeutic plasma exchange with a prismaflex tpe2000 set and a prismaflex control unit, a patient suddenly passes away.It was reported that no alarms were issued by the control unit.The cause of death was not reported.It was not reported if an autopsy was performed.No additional information is available.

• Brand Name: PRISMAFLEX TPE
• Type of Device: SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEYZIEU; 7, av lionel terray, b.p. 126; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12591709
• MDR Text Key: 275221643
• Report Number: 8010182-2021-00302
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): Y
• Reporter Country Code: SW
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2021

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: 107144
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 10/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX CONTROL UNIT
• Patient Outcome(s): Death