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

Catalog Number 955558

Device Problem Device Alarm System (1012)

Patient Problems Cardiac Arrest (1762); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/01/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter first name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during continuous renal replacement therapy (crrt) using a prismax machine, several alarms b1892 : dialysate scale load cell mismatch occured.The operator could not unload the filter and the prismax screen went blank.The treatment was ended without the extracorporeal (ec) blood being returned to the patient.The patient experienced a cardiorespiratory arrest.The patient outcome was not reported.No additional information is available.

Manufacturer Narrative

Additional information added to h3, h6, h10.The device was not received for evaluation; however, the device was evaluated on site by a qualified baxter technician.Upon evaluation it was a deviation of dialysis scale was identified.To resolve the issue, a calibration was performed.A short simulated therapy was successfully performed.The event history log review showed that the treatment was interrupted after the alarm "b1892-dialysate scale load cell mismatch" was triggered.The machine stopped and went in therapy recovery.The machine rebooted by itself; however, the user did not manually return the blood.The reported condition was verified.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 - 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: 15147612
• MDR Text Key: 297062287
• Report Number: 3003504604-2022-00023
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414124359
• UDI-Public: (01)07332414124359
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 955558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 40 YR
• Patient Sex: Male