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

Catalog Number 955626

Device Problem Device Alarm System (1012)

Patient Problem Cardiovascular Insufficiency (4445)

Event Date 03/29/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that an air in blood alarm was generated during continuous renal replacement therapy (crrt) using a prismax control unit.The extracorporeal circuit was found to be full of air.The patient was reported to have decompensated and was intubated.The outcome was not reported.No additional information is available.

Manufacturer Narrative

Additional information: h6 and h10.The device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.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: 14193958
• MDR Text Key: 289976582
• Report Number: 3003504604-2022-00011
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 955626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 05/27/2022
• 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