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

Model Number 0998-00-0800-53

Device Problem Material Rupture (1546)

Patient Problems Low Oxygen Saturation (2477); Confusion/ Disorientation (2553); Diminished Pulse Pressure (2606); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/09/2021

Event Type  malfunction  

Event Description

Registered nurse (rn) noted intra-aortic balloon pump was not augmenting or filling appropriately, contacted nurse practitioner (np) from cardiovascular intensive care unit (cvicu) who confirmed finding at bedside.Upon inspection of tubing, found blood indicating balloon rupture.Pressor requirements quickly escalated with mean arterial pressure 40-50 eventually requiring norepinephrine , neosynephrine and epinephrine.Additional providers notified and cardiologist, fellow and cardiovascular intensivist came to bedside to exchange balloon and pump.Patient experienced oxygen desaturation during procedure and disorientation requiring intubation and ventricular tachycardia requiring cardioversion that return to rhythm; however patient was pulseless electrical activity (pea) as there was no palpable pulse.Cardiopulmonary resuscitation (cpr) began, code team called and return of spontaneous circulation (rosc) achieved.Unfortunately balloon was not saved; however pump and tubing connected to balloon were and turned over to biomed.

• Brand Name: CARDIOSAVE HYBRID, TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• MDR Report Key: 12727375
• MDR Text Key: 279333067
• Report Number: 12727375
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: 3000141070
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25915 DA