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

Catalog Number	955626
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient passed away while performing continuous renal replacement therapy (crrt) with a prismax control unit.The cause of death was not reported.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information added to b1, h1, h6 and h10.Corrected information added to b5: the customer contacted baxter requesting a functional check on a prismax control unit as a patient passed away while performing continuous renal replacement therapy (crrt).There was no issue reported with the prismax control unit and the hospital was following their procedure for investigating these events.Baxter made multiple attempts to contact the customer to obtain additional information related to the patient event, patient¿s demographics, medical condition or medical history, medical intervention, details related to crrt, cause of death, whether an autopsy was performed, or any alarms or issues observed with baxter products; however, no response was received from the customer.H10: the device log files were reviewed which confirmed the device functioned as intended throughout treatment raising alarms according to specifications.The pressure tests performed by the machine during treatment were within tolerance limits.No device malfunction was identified.Based on additional information from the evaluation, the prismax control unit was determined not to be a factor in the event of patient death.The event history log review showed no keystrokes, programming, or use related events that indicated and/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.No device malfunction was identified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAX MACHINES
• Common Device Name: 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 ; 2242702068
• MDR Report Key: 14014199
• Report Number: 3003504604-2022-00008
• Device Sequence Number: 20407776
• Product Code: KDI
• UDI-Device Identifier: 00085412639499
• UDI-Public: (01)00085412639499
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 955626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown