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

Catalog Number 115309

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

Prismaflex st100 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 pone number: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

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

Manufacturer Narrative

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 received for evaluation.A visual inspection, a leak test and a simulated test were performed and the reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction: b4/f8: date of this report in mdr follow up #1 is being corrected from blank to 03/05/2021.

• Brand Name: PRISMAFLEX ST100
• Type of Device: BE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11321626
• MDR Text Key: 239595500
• Report Number: 8010182-2021-00048
• Device Sequence Number: 1
• Product Code: KDI
• 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: 07/29/2021

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: 115309
• Device Lot Number: 20H2901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 02/19/2021; 07/01/2021
• Supplement Dates FDA Received: 03/05/2021; 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1