MAUDE Adverse Event Report: KIMBERLY-CLARK PUMP

Model Number TDA-PPU-1

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2015

Event Type  malfunction  

Event Description

During a radiofrequency ablation (rfa), there was an equipment malfunction.The machine would prime but not ablate and gave an error message of 'pump mapping failure.' staff and physician attempted to troubleshoot the problem but were unable to correct it.The rfa was successfully completed with backup equipment.Staff reached out to the vendor directly for assistance and repair/replacement of the equipment and did not follow the proper procedure for reporting patient equipment failure.Rfa equipment that failed was cooledrf by halyard heath.After the procedure, a representative indicated that they had heard of the pump failing sooner than expected from peers.

• Brand Name: PUMP
• Type of Device: PUMP
• Manufacturer (Section D): KIMBERLY-CLARK
• MDR Report Key: 5137878
• MDR Text Key: 28069352
• Report Number: MW5056899
• Device Sequence Number: 2
• Product Code: MEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Report Date: 10/02/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TDA-PPU-1
• Device Catalogue Number: TDA-PPU-1
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 117