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

Model Number 107493

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 08/03/2022

Event Type  malfunction  

Event Description

Continuous renal replacement therapy (crrt) machine shut down twice within 7 hours, always tmp./pressure.Called product support, and they made suggestions and said if it continued to happen it sounded like a machine failure and to call service.It failed again suddenly.Second machine that fails within the 24 hours.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15282607
• MDR Text Key: 298480350
• Report Number: 15282607
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 107493
• Device Catalogue Number: 115269
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2022
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27740 DA
• Patient Sex: Male