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

Catalog Number 955558

Device Problem No Visual Prompts/Feedback (4021)

Patient Problem Blood Loss (2597)

Event Date 01/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during continuous renal replacement therapy using a prismax control unit, the device experienced a locked screen.It was reported the screen ¿got frozen¿ while the nurse was checking the history, specifically "the pressures".It was reported ¿there were no graphics and the screen was blocked¿.The treatment was ended without the extracorporeal blood being returned to the patient.It was reported during a manual blood restitution there are no air bubble detection, access or return alarms.It was reported prior to the event, the patient¿s hemoglobin was 5.0mmol/l, then decreased to 4.4mmol/l, after the event.The patient received a concentrated erytocytes blood transfusion.It was reported ¿there were no further hemodynamic consequences¿.At the time of this report, the patient outcome was not reported.No additional information is available.

Manufacturer Narrative

Additional information added: h10: the prismax device was evaluated on site by a qualified baxter technician.The display wiring and connectors were verified and approved after the reported "frozen" screen.No machine malfunction/deviation was identified.The event history log review could not directly confirm that the screen "froze".However, after a change of the effluent bag, there were no more events indicating any operator interaction, consistent with the reported scenario.A device history review revealed no issues that could have caused or contributed to the reported event.The reported issue was not verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9722867
• MDR Text Key: 189331085
• Report Number: 3003504604-2020-00001
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K190910
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955558
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AUTO EFFLUENT SET; PRISMAFLEX SET HF1400; THERMAX BLOOD WARMER UNIT
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 88