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

Catalog Number 955468

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

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.The actual device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of the provided photos showed a crack on the dialysate port of the filter which resulted in the fluid leakage.The reported condition of leak was verified.The cause of the crack was due to a transportation issue.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.

Event Description

It was reported that during priming with a prismaflex st100 set, an external fluid leakage from the dialysate port was observed.There was no patient involvement.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 showed that the dialysate port was cracked resulting in the leak.The reported condition was verified.The cause was likely a mechanical shock during transportation.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 ST100
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10817213
• MDR Text Key: 229590815
• Report Number: 8010182-2020-00240
• 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: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955468
• Device Lot Number: 20B2324M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1