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	Overheating of Device (1437)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that "overheating" of a prismax machine was observed after being used for extended periods.In all instances, extracorporeal blood was manually returned to the patient.Blood clots were observed, and the patients were transfused.No additional information is available.
Additional Manufacturer Narrative
Additional information added to h3, h6 and h10.The actual device was evaluated on site by a biomedical technician.No overheating of the machines was confirmed, and no device malfunction was identified.The reported condition was not verified.The cause of the condition could not be determined; however, the most likely the cause was due to a ¿lack of nurse education¿.The unit where the issue occurred also "reflected it was nursing error".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
• 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 60073 ; 2242702068
• MDR Report Key: 16014344
• Report Number: 3003504604-2022-00038
• Device Sequence Number: 7334167
• Product Code: KDI
• UDI-Device Identifier: 00085412639499
• UDI-Public: (01)00085412639499
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2023

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?: No
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown