MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX ST60; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 115308

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

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

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

Eprismaflex st60 set ckt 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.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 a prismaflex st60 set, an external blood leak was observed due to a torn line.The amount of blood loss was reported as 130 ml.The treatment was immediately stopped.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device was not received for evaluation, however a picture was provided.The visual inspection observed an external fluid leak from the access line multi connector.The reported condition was verified.The cause was not 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 ST60
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11415257
• MDR Text Key: 244521170
• Report Number: 8010182-2021-00089
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414118372
• UDI-Public: (01)07332414118372
• 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: 04/09/2021

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 Expiration Date: 06/30/2022
• Device Catalogue Number: 115308
• Device Lot Number: 20G2207A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1