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

Catalog Number 955626

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/05/2023

Event Type  Injury  

Event Description

It was reported that, during continuous renal replacement therapy with a prismax machine, the machine "ended treatment with call service powering off suddenly without restarting itself".The bedside nurse reported treatment was ended without the extracorporeal blood being returned to the patient.It was further reported the patient received a blood transfusion.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

H10: a service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information added to h6 and h10.H10: the event history log was further reviewed.During review the log showed the system halted operation on (b)(6) 2023 at 21:33 due to a b1897 ¿ replacement scale load cell mismatch.The replacement bag was just changed.The reported condition was not verified; however, the most probable cause was due to the act of closing the scale.This could not be verified without a device analysis.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 - BROOKLYN PARK; 7601 northland drive; n suite 170; minneapolis MN 55428
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17641844
• MDR Text Key: 322168970
• Report Number: 3003504604-2023-00022
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00085412639499
• UDI-Public: (01)00085412639499
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 10/09/2023; 11/08/2023
• Supplement Dates FDA Received: 10/31/2023; 12/06/2023
• 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
• Patient Outcome(s): Required Intervention