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

Model Number REF 95592

Device Problems Insufficient Heating (1287); Improper Flow or Infusion (2954); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Alteration in Body Temperature (4568)

Event Date 04/06/2021

Event Type  malfunction  

Event Description

Patient on continuous renal replacement therapy (crrt). Machine's warming circuit not working during the day, so patient's temp as low as 92 degrees. Id number on machine 38537. Patient ordered for ct so patient needed to get disconnected from crrt (@1600). So, new machine obtained when ready to restart. New machine's warmer also not working, so did not use. (trailed equipment in the hallway. ) sent back to csd. 2nd "new" machine (# 58301) arrived, warmer working. Set up machine and new filter. Started crrt. Then had a flow error for pbp that could not be fixed. I disconnected and reconnected several times, changed the dialysate bag, checked for issues/leaks, etc. Not able to troubleshoot. Treatment stopped. Trailed again on previous machine. Warmer now working. Set up crrt and running w/o issue. But did not restart treatment until 2330 (was off for extended period 2/2 machine issues).

• Brand Name: PRISMAFLEX
• 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: 11776234
• MDR Text Key: 249027217
• Report Number: 11776234
• 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: 04/13/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: REF 95592
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown