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

Catalog Number 107144

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection observed an external blood leak from the access line post pup connection with the support plate.The reported condition was verified.The cause was undetermined.A batch review was conducted and there was one manufacturing nonconformity recorded regarding this lot number, which was unrelated to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during treatment with a prismaflex tpe2000 set, an external blood leak was observed on the filter side of the blood pump by the machine.Pressure was applied to the area of the leak, and the patient's blood was returned, and the treatment was terminated.There was no patient injury or medical intervention associated with this event.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 60073 ; 2242702068
• MDR Report Key: 11008512
• MDR Text Key: 221541765
• Report Number: 8010182-2020-00295
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): Y
• Reporter Country Code: TU
• PMA/PMN Number: NI
• 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: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 107144
• Device Lot Number: 18J2905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2020
• 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: Unknown
• Patient Sequence Number: 1