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

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.

Manufacturer Narrative

It was reported during follow up that prior to starting treatment, the patient was described as ¿unable to move at all due to weak muscles and having difficulty to move mucus¿.The patient¿s blood pressure was 120/65 mmhg and pulse was 70 bpm and the patient was described as circulatory stable.Based on additional information received from downloaded treatment data, the prismaflex tpe2000 was determined not to be a factor in the reported death.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction: this report is a duplicate of manufacturer report number 8010182-2021-00302.All information can be found under manufacturer report number 8010182-2021-00302.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 12568723
• MDR Text Key: 274495481
• Report Number: 8010182-2021-00300
• 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: Distributor
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2021

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?: Yes
• 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: Not provided
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 10/07/2021; 10/28/2021
• Supplement Dates FDA Received: 10/07/2021; 11/18/2021
• 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; PRISMAFLEX CONTROL UNIT
• Patient Outcome(s): Death
• Patient Age: 62 YR
• Patient Sex: Male