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

Catalog Number 955724

Device Problems Protective Measures Problem (3015); Unexpected Shutdown (4019)

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

Event Date 06/24/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported during continuous renal replacement therapy (crrt) using a prismax machine the patient lost two circuits of blood.The prismax machine was used in conjunction with a thermax blood warmer unit and an extracorporeal membrane oxygenation (ecmo) system.During crrt the machine underwent a ¿system update¿ twice, which caused ¿a system lock-down, preventing rinse-back¿.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device was not received for evaluation; however, it was inspected on-site by a baxter qualified technician.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The technician checked the date/time system, the pressure monitoring system, and the scales which were all found to be performing within specification limits.The reported condition was not verified.The event history log review showed treatment started on (b)(6) 2023 and run with the extracorporeal circuit secondary to an ecmo system.This resulted in the access and the return pressures reversed along the treatment in comparison with the usual condition of the crrt treatment as the access was in the range of +200 mmhg and the return in the range of +15 mmhg.Then, the prismax machine generated the safety alarm b1541 ¿ effluent pod repositioning failure and after it could not complete the first pressure pod repositioning of the treatment.A power failure decided by the user terminated the treatment.Also, it should be noted that ecmo is an off-label use of prismax machine.The reported condition was not verified.The cause of the condition could not be determined.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAX MACHINES
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS; via modenese, 66; medolla modena 41036 ; IT 41036
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17385552
• MDR Text Key: 320124785
• Report Number: 3003504604-2023-00017
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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: 955724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 08/31/2023
• Supplement Dates FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ECMO; THERMAX BLOOD WARMER UNIT