MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 8FR. 50CC IAB WITH ACCESSORIES, US ONLY; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0576-01U

Device Problems Device Displays Incorrect Message (2591); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 03/25/2022

Event Type  malfunction  

Event Description

Patient came to unit from the cardiac cath lab after placement of an intra-aortic balloon pump (iabp).Within 20 minutes of arrival to the unit, the pump started alarming "iab optical sensor failure." troubleshooting included unplugging and replugging the orange fiber optic cable with no resolution of alarm., was unable to get any pressure wave form or numbers for augmented pressure/assisted pressures, heart rate, etc.Switched out the actual balloon pump machine and fiber optic cable, helium tubing, bs ekg cables switched over to new pump.Same alarm of "iab optical sensor failure" continues.Called the perfusion tech on call who called the maquet representative.Troubleshooting phone call from representative included hooking up a manual arterial line pressure transducer to the machine to get a pressure waveform, as there were no waveforms on the screen other than ekg.Iabp started alarming "unable to update timing" after manual pressure cable was connected and zeroed.Iabp continues to alarm "unable to update timing every one minute or so." pump turned to manual per doctor to diminish alarm problem.The next morning, the iabp was placed in semi-auto mode and it did not alarm at all in regards to "unable to update timing so the nurse left it in semi-auto mode.The manual pressure transducer was still connected.Iabp mean in the 80-90's, wave form shows late inflation due to iabp optical sensor failure.Cardiologist pulled back slightly on the catheter for possible kink in the line.Wave form looks slightly better.Determined the root cause that most likely it is an issue with a kinked/damaged fiber optic tip on the catheter itself.Patient underwent aortic to coronary bypass graft the next am.The catheter was removed one day post op.The catheter was saved after removal and will be returned to the manufacturer for inspection upon their request.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB WITH ACCESSORIES, US ONLY
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law dr; fairfield NJ 07004
• MDR Report Key: 14117487
• MDR Text Key: 289338590
• Report Number: 14117487
• 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: 04/05/2022,03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0684-00-0576-01U
• Device Catalogue Number: 0684-00-0576-01U
• Device Lot Number: N/D
• 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: 04/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA
• Patient Sex: Male
• Patient Weight: 76 KG