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

Catalog Number 955725

Device Problem No Display/Image (1183)

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

Event Date 03/03/2023

Event Type  Injury  

Event Description

It was reported that during continuous renal replacement therapy (crrt) with a prismax machine, blood loss occurred.During crrt, an access extremely negative alarm was generated, and the patient access was adjusted.Treatment continued and again an access extremely negative alarm triggered and the prismax screen was ¿completely locked and it is not possible to press on it¿.Treatment was discontinued without the extracorporeal blood being returned to the patient.No patient symptom was reported; however, to compensate for the blood loss the patient received a blood transfusion.No additional information is available.

Manufacturer Narrative

Initial reporter facility name: (b)(6).Initial reporter address: (b)(6).Initial reporter city: (b)(6).The device was not received for evaluation; however, it was inspected on-site by a baxter qualified technician.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.System self-test (sst) of display, main board, safety board, power board, scales, and pressure sensors were performed and the device performed according to product specifications.Priming and simulated treatment performed were also simulated and there were no issues noted.The reported condition was not verified.The event history log review showed the access extremely negative alarm.The alarm was not cleared and the user was forced to end the treatment.The user disconnected and reconnected the power cable likely due to unresponsive screen.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; minneapolis MN 55428
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16674650
• MDR Text Key: 312618054
• Report Number: 9616240-2023-00002
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 955725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• 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
• Treatment: PRISMAFLEX ST150 SET.
• Patient Outcome(s): Required Intervention