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

Catalog Number 107144

Device Problem Insufficient Information (3190)

Patient Problem Dehydration (1807)

Event Type  Injury  

Event Description

It was reported that during continuous renal replacement therapy (crrt) with an unknown number of prismaflex tpe2000 sets and a prismax machine, an unknown number of patients experienced dehydration, further specified as ¿have made patients dehydrated¿.It was also reported that there was an increase of blood hemoglobin results and minimal changes in blood pressure (no values provided).According to the reporter, additional fluid infusions were required.Additionally, it was reported that ¿filter sets have had bad life spans and do not last a very long period of time during treatment¿.No blood loss, patient symptoms or medical interventions related to "bad life spans" was reported.No additional information is available.

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX SETS (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: 18837889
• MDR Text Key: 336904213
• Report Number: 8010182-2024-00077
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 107144
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PRISMAX MACHINE.
• Patient Outcome(s): Required Intervention