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

Model Number M150

Device Problems Infusion or Flow Problem (2964); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 08/18/2021

Event Type  malfunction  

Event Description

We have been having issues with crrt filters and notice that it is the crrt disposables from baxter.Lot 20h1701: attempted filter set up but during prime the purple line would not prime.Machine continued to alarm stating the purple line was clamped.The nurse made sure there were no kinks or clamps in place.She moved from the spikeless access to a spiked bag of fluid.After continuing multiple times without success, she broke down the system and reset up the machine.She did have to waste her entire set (ae and thermax bag).There was already fluid in the effluent bag so the ae set could not be reused.Lot 21a2204: during filter set up, heparin was ordered.Set up initiated with heparin syringe.The machine alarmed stating there was no syringe in place.The nurse attempted to remove the syringe and replace it several times.She never could get the machine to recognize the syringe she installed.After removing the new set up she attempted to flush the heparin line.Fluid will not flow through the heparin line.The entire new set up needed to be discarded since fluid was already in the ae set.Lot 20j0908: during machine setup filter could not be recognized.Nurse attempted to unload and reload several times.She attempted to place light pressure on the filter set as the pumps loaded as she was instructed to do previously by icon.That did not help load the set.Filter and thermax bag were wasted during set up.Ae was reused.

• 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: 12421038
• MDR Text Key: 269812429
• Report Number: 12421038
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M150
• Device Catalogue Number: 109990
• Device Lot Number: 20H1303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2021
• Date Report to Manufacturer: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1