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

Catalog Number 113874

Device Problems Failure to Read Input Signal (1581); Failure to Deliver (2338)

Patient Problem Anemia (1706)

Event Date 06/17/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter address - (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during continuous renal replacement therapy (crrt) using a prismaflex control unit, the machine generated an effluent scale malfunction alarm at an unspecified time during treatment.The operator reportedly pressed retest, but there was no response from the machine.The treatment was ended without the 189 ml extracorporeal blood being returned to the patient.The reporter stated that the patient¿s hemoglobin level decreased as a result of the blood loss.One unit of blood infusion was provided to the patient.The patient outcome was not reported.No additional information is available.

Manufacturer Narrative

The event history log review confirmed that a scale (effluent) alarm was issued.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Nevertheless, the effluent scale was replaced as per the customer's request, the scale was calibrated and a simulated therapy was successfully performed.A nonconformance was opened to address this issue and a related capa has been opened to address a change of the software which was identified to be the contributing factor.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: 12268027
• MDR Text Key: 265137943
• Report Number: 9616026-2021-00039
• 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: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 113874
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.
• Patient Outcome(s): Other