MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number HF1400

Device Problems Complete Blockage (1094); Defective Device (2588); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2021

Event Type  malfunction  

Event Description

Nursing staff were attempting to change out the filter cartridge on the "baxter prismax" continuous renal replacement therapy (crrt) machine, and 4 times in a row, received the same error message on the screen after the machine attempted to prime the lines with iv fluid.The machine takes 10 minutes to prime the iv lines, and on all 4 occasions, the timer stopped at 9:08, stating that there was a blockage in the line, which there was not.Each time this stoppage happened, an entire new filter must be brought out, and all of the iv bags must be replaced, which takes approximately 30 minutes.With this happening 4 times in a row, it caused an approximate 2-hour delay in patient care.The 5th filter that was used worked properly, and the staff was able to continue with the crrt for the patient.All 4 of the failed filters were from the same lot number.

• Brand Name: PRISMAFLEX SET
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO INDUSTRIES; one baxter parkway; deerfield IL 60015
• MDR Report Key: 12438289
• MDR Text Key: 270306772
• Report Number: 12438289
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2021,08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HF1400
• Device Catalogue Number: 107142
• Device Lot Number: 21B2204
• 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: 08/30/2021
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA