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

Catalog Number 114489

Device Problem Device Alarm System (1012)

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

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during treatment with a prismaflex machine, a scales alarm was generated two times followed by a dialysate scale sensor alarm.The three treatments were ended without the extracorporeal (ec) blood being returned to the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information added to h3, h6 and h10 h10: the device was inspected on site by a qualified technician.A dialysate scale calibration was performed and the reported event was not duplicated.The qualified technician checked the scales, pressure and syringe drivers and no issues were observed.The qualified technician performed set loading, prime, priming test, and a one hour simulated treatment and no abnormalities were observed.The reported condition was not verified.The cause of the malfunction is undetermined.A device history review revealed no issues that could have caused or contributed to the reported issue.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Based on ongoing investigations, the firmware of the scales interacting with new software versions 7.21 and 8.20 was identified as the cause.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11614383
• MDR Text Key: 243802484
• Report Number: 9616026-2021-00015
• 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: 04/30/2021

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: 114489
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1