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

Model Number N/A

Device Problem Device Alarm System (1012)

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

Event Type  Injury  

Manufacturer Narrative

The event occurred on an unreported date in (b)(6) 2022. Initial reporter pager #: (b)(4). Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during continuous renal replacement therapy with an unspecified number of prismax machines on several patients, black-out screens occurred due to a reboot of the machine following a post failure code 1404 alarm being generated. The reboot usually takes less than one minute; however, the medical staff was not aware of this feature and did not understand the event. The medical staff pressed the power button resulting in the therapy recovery option no longer being available. This resulted approximately one (1) unit of blood loss on an unspecified number of patients. The extracorporeal blood was not returned to the patients and an unknown number of patients required a blood transfusion. The patient outcomes were not reported. No additional information is available.

• Brand Name: PRISMAX
• 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: 13427945
• MDR Text Key: 288599585
• Report Number: 3003504604-2022-00001
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 955626
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 02/02/2022 Patient Sequence Number: 1