MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Device Problems Communication or Transmission Problem (2896); Inadequate User Interface (2958); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 09/03/2020

Event Type  malfunction  

Event Description

Nursing was drawing labs from the sidearm of a patient when the balloon pump on that patient started alarming.The pump displayed "x's" over the helium and battery icons, the screen was frozen, and the pump stopped pumping.The pump also alarmed for an electrocardiogram lead fault, but all leads were on.Nursing could not restart the pump, and therefore chose to swap it out with a new pump.Manufacturer response for intra-aortic balloon pump, optimus ac3 (per site reporter).A software engineering manager at teleflex reviewed pump log files from the incident.Below is their response: "the red 'x' on battery and helium tank indicates that the user-interface/screen did not receive real-time data from the pump-control computer ("cpu").There are a lot of possibilities which could cause it, in both hardware and software.If we know that the hardware is good, we'll dig in the software for a potential problem somewhere." a teleflex field engineer came onsite to inspect the pump.Below is their response: "i could not reproduce the original reported symptoms: pump alarmed, stopped pumping, screen froze, flashing x's on he and batt icons.I replaced the cpm board revision 2 with a new cpu board revision 5 as that appears to be the most likely culprit if the problem was caused by a hardware issue.I also replaced the power switch as it was very sensitive.A slight tapping on the switch would cause the pump to restart.I also replaced the battery as the run time was only 40 minutes.The pump has been running in clinical engineering for the last 2 hours.I believe that it will be returned to service shortly.".

• Brand Name: ARROW
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 10703916
• MDR Text Key: 212092729
• Report Number: 10703916
• Device Sequence Number: 1
• Product Code: DSP
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 10/07/2020
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1