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

Catalog Number 115309

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 11/18/2020

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.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during priming with a prismaflex st100, a particle in the set (filter pot) was observed.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the actual device was available and a photograph of the sample was provided for evaluation.The visual inspection of the provided picture showed the presence of a whitish precipitate in the access circuit of the set.The reported condition was verified.There was no visible particulate matter or precipitate in any of the lines of the actual set , nor in the bag of dextrose 5% priming solution.The whitish precipitate observed on the picture provided by the customer had dissolved since the event occurred.An infra-red analysis of liquid collected from the set¿s access line and anticoagulant line and from the returned dextrose 5% priming solution bag was conducted and the result was inconclusive.A test was performed to confirm the absence of futhan (nafamostat mesylate) in the sample and the sample didn't contained futhan.The reported condition was not verified in the sample.The cause could not be 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 ST100
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10990542
• MDR Text Key: 220927172
• Report Number: 8010182-2020-00292
• 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
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• 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: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1