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 Problems Hypersensitivity/Allergic reaction (1907); Hyperthermia (1909); Nausea (1970); Vomiting (2144); Chills (2191)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that one hour and 45 minutes after starting therapeutic plasma exchange (tpe) treatment using a prismaflex tpe set, the patient experienced chills (37°c.) and the extracorporeal circuit was returned due to high transmembrane pressure alarm that was triggered three times.Treatment was discontinued.It was reported this was the patient's first plasmapherese tpe session (with albumin).A new prismaflex tpe set was used to continue treatment.After continuing treatment with the new set, the patient experienced chills, hyperthermia at (38.5°c), nausea and vomiting.Treatment was discontinued, and the patient was treated with paracetamol (1g) and dexchlorpheniramine (2mg).No additional information is available.

Manufacturer Narrative

B5: it was reported during follow up that priming with injected nacl solution was performed for approximately less than 10 minutes.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: PRISMAFLEX TPE
• Type of Device: SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9915855
• MDR Text Key: 188646137
• Report Number: 8010182-2020-00025
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 04/29/2020

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: 10/01/2021
• Device Catalogue Number: 107144
• Device Lot Number: 19J0501
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 04/23/2020
• Supplement Dates FDA Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX CONTROL UNIT
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR