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

Catalog Number 107640

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported during treatment with two (2) units of a prismaflex st150 set and a prismaflex control unit , a decent sized hole was observed in the bag causing it to leak and empty quickly.An air in blood alarm was generated, however, the bag empty alarm was not triggered.The treatment was terminated without the extracorporeal (ec) blood being returned to the patient.The treatment was restarted with a new set, and after six (6) hours of treatment, the pre blood pump bag had run dry and again an air in blood alarm was triggered.The treatment was once again terminated without returning the ec blood to the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Based on the information provided a hole was observed on the replacement bag.This bag is not a part of the prismaflex set.There was no defect reported on the set.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: 12344733
• MDR Text Key: 267344566
• Report Number: 9616026-2021-00044
• Device Sequence Number: 1
• Product Code: KDI
• 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: 10/29/2021

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: 107640
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX MACHINE; PRISMAFLEX MACHINE