MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX ST100; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 955468

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.Prismaflex st100 set c 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.

Event Description

It was reported that an external fluid leak due to luer connector damage was observed on a prismaflex st100 set during priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information added.Device code added for fluid leak.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

B5: the external fluid leak was due to a damaged tube.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; however, a picture of the impacted set was provided.The visual inspection observed that the effluent line was perforated.The reported condition was verified.The cause could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX ST100
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11752163
• MDR Text Key: 249284923
• Report Number: 8010182-2021-00151
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414123468
• UDI-Public: (01)07332414123468(10)
• 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,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• 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: 955468
• Device Lot Number: 20G2904
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1