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

Catalog Number 107144

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2020

Event Type  malfunction  

Manufacturer Narrative

The actual device was not available; however, two photograph of the sample were provided for evaluation.Visual inspection of the photos showed blood from the effluent fluid in the drain bag and on the effluent line.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during therapeutic plasma exchange (tpe) treatment with two units of prismaflex tpe 2000 sets, three internal blood leaks were observed.It was reported blood was visible in the effluent bag and in the line.Treatment was discontinued.The effluent was sampled, and a red blood cell count was performed.The result was reported as ¿patient without anemia¿.Treatment was restarted with a tpe2000 set with a different lot number and no issues were noted.There was no report of 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: 10868365
• MDR Text Key: 228839839
• Report Number: 8010182-2020-00255
• Device Sequence Number: 1
• Product Code: MDP
• UDI-Device Identifier: 07332414069339
• UDI-Public: (01)07332414069339
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 107144
• Device Lot Number: 19I0905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA 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