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 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter postal code: (b)(6).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 after reconnecting the patient for continuous renal replacement therapy using a prismaflex st 150 set, the return line was ¿gushing out from behind the blue screw/leur lock-opposite to the side where the blue luer lock was attached to the permacath lumen¿.Treatment was stopped and it was noted air was in the return line.The extracorporeal (ec) blood was not returned to the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The visual inspection of the provided picture did not identify any specific defect on the impacted set.The reported condition was not 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.

• 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: 11088948
• MDR Text Key: 224358164
• Report Number: 8010182-2020-00323
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414075651
• UDI-Public: (01)07332414075651
• Combination Product (y/n): Y
• 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: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 107640
• Device Lot Number: 20E0303
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1