MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX ST150; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 107640

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

Prismaflex st150 set has been temporarily approved for use in the us under emergency use authorization (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a disconnection of the access line from the y connector during dialysis using a prismaflex st150 was observed.It was reported that the connection had been checked prior and during treatment.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, a photograph of the sample and one retained sample were evaluated.Visual inspection of the photo did not identify any specific issue on the set.Visual inspection of the retention sample did not identify any abnormalities that could have contributed to the reported condition.The sample was found within specification including testing of the male luer connection and dimensional verification of the component.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.It was reported the set was connected to the priming accessory between the patient catheter and the luer lock of the access line, which is a user error and an off-label use.The instruction for use for the prismaflex set has a caution: ¿the prismaflex control unit may not be able to detect disconnections of the set from the patient¿s catheter.Carefully observe the set and all operations while using the prismaflex system for a patient treatment¿.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX ST150
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11290595
• MDR Text Key: 239578663
• Report Number: 8010182-2021-00036
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 107640
• Device Lot Number: 20J1403
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JOLINE CATHETER; PRISMAFLEX CONTROL UNIT