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

Catalog Number 955558

Device Problem Complete Loss of Power (4015)

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

Event Date 11/25/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a prismax machine unexpectedly shut down during continuous renal replacement therapy (crrt) and it was not possible to ¿clear the screen¿.The treatment was ended without the extracorporeal (ec) blood being returned to the patient.No patient symptom was reported but a blood transfusion was prescribed prior to restarting the crrt treatment.No additional information is available.

Manufacturer Narrative

H10: the device was evaluated on site by a qualified technician.The reported condition was not verified.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Log file analysis confirmed that the treatment was interrupted when the alarm b1541: ¿effluent pod reposition failure¿ was generated by the device.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAX CONTROL UNIT
• 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 ; 2242702068
• MDR Report Key: 13088147
• MDR Text Key: 282783733
• Report Number: 3003504604-2021-00007
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414124359
• UDI-Public: (01)07332414124359
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 955558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/27/2021
• Supplement Dates Manufacturer Received: 01/24/2022
• Supplement Dates FDA Received: 01/27/2022
• 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: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention