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

Event Date 05/20/2023

Event Type  Injury  

Event Description

It was reported that during continuous renal replacement therapy (crrt) using a prismax machine, a system error alarm was triggered and the prismax machine stopped working.The treatment was terminated without the extracorporeal blood being returned to the patient with a blood loss of 217 ml.The patient reportedly became anemic and received a blood transfusion.No additional information is available.

Manufacturer Narrative

E1: initial reporter postal code: (b)(6).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information added to h3, h6 and h10.The device was not received for evaluation; however, the device was evaluated by an onsite qualified baxter technician.Upon onsite evaluation it was observed that a filter pressure pod reposition failure occurred.An automatic reposition pressure system (arps) system self-test (sst) was performed and found that the filter transducer would not stabilize.The reported condition was verified.The filter pressure port was removed and replaced.A full pressure pod calibration, pressure sst and arps sst were successfully performed with no issues noted.The event history log was reviewed and showed that treatment started two days prior to the reported event at16:56, and on the day of the reported event at 13:31, a ¿filter pressure pod reposition failure¿ alarm was generated causing the machine reboot.After the machine rebooted, the therapy recovery was not allowed as the ¿motor data freshness fault¿ alarm was generated, and the device was switched off by the user.A device history review revealed no issues that could have caused 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.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; suite 170; brooklyn park MN 55428
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17163572
• MDR Text Key: 317534282
• Report Number: 3003504604-2023-00014
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 07/24/2023

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: 955558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 07/24/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention