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 11/16/2020

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 (not further described) was observed in the filter pot.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction added: the event was reported to have occurred on (b)(6) 2020.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was received 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 whitish precipitate observed on the picture provided by the customer was confirmed on the sample received.The reported condition was verified.It can be stated that the presence of anticoagulant futhan caused the observed white precipitate to form in the priming solution.The cause is therefore not device related.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: 10975071
• MDR Text Key: 224782528
• Report Number: 8010182-2020-00288
• 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: 01/07/2021

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: 20G1203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 12/09/2020; 01/06/2021
• Supplement Dates FDA Received: 12/09/2020; 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1