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

Model Number PRISMAFLEX

Device Problems Melted (1385); Overheating of Device (1437); Smoking (1585); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2018

Event Type  malfunction  

Event Description

There was an incident this morning with a crrt circuit heater that malfunctioned and burned through/melted a patient's return line.Fortunately, the patient appears to be unharmed but while the incident is being investigated by baxter, there are a few precautions to be taken.Nephrology has made it clear that they still want patients to have their circuit heaters on unless the patient is febrile.Please examine all circuit heater sleeves prior to placement on the return line - be looking for any breaks or bubbling in the material.Continue to intermittently examine the sleeve and the return line throughout therapy - this will require a removal of the sleeve with each shift to inspect line integrity as well.If you notice any changes in the sleeve or that it feels hotter than usual, peel away the sleeve to inspect the line.The issue has been taken to the top level of baxter (as well as our own risk management), so hopefully there will be more information to come.It may be something as simple as changing the cleaning solutions we use for the product.Additional information: in report of patient on crrt machine alarming and reached a hard limit and needed to be discontinued.Assisted night shift rn with take down and circuit warmer hose was hot to the touch with blister on surface opened warmer and crrt tubing melted and smoke /steam present.Notified charge rn immediately.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO AB; one baxter parkway; deerfield IL 60015
• MDR Report Key: 8277376
• MDR Text Key: 134117070
• Report Number: 8277376
• 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: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PRISMAFLEX
• 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: 12/28/2018
• Date Report to Manufacturer: 01/25/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14235 DA