MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number CARDIO SAVE HYBRID

Device Problem Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2020

Event Type  malfunction  

Event Description

Loud constant alarm heard from balloon pump.When assessing device, all waveforms were a flat line and all numbers were at zero and pump was alarming internal malfunction.When troubleshooting the device, the recommendation from the device was to turn the device off for ten seconds and to turn it back on.When this was attempted, the device did not turn back on.Patient was quickly transferred over to a new device instead.No harm to patient noted.Engineering evaluation: when tested later, the machine booted normally.Review of the error log showed two entries at the time of the incident.Screen shot of log attached.Review of the fault table showed these errors had only occurred once.Per manufacturer advice, no further corrective action is needed.Machine ran with simulator 48 hours with no further events.Manufacturer response for intra-aortic balloon pump, (brand not provided) (per site reporter).Since the error only occurred once, they said it was nothing to worry about.

• Brand Name: CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10061111
• MDR Text Key: 191156938
• Report Number: 10061111
• 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: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CARDIO SAVE HYBRID
• 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: 04/14/2020
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA