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

Model Number 0684-00-0576-01U

Device Problem Device Alarm System (1012)

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

Event Date 03/21/2020

Event Type  malfunction  

Event Description

The intra-aortic balloon pump (iabp) was alarming: leak alert.Nurse noted blood in iabp catheter.Balloon catheter was removed from left axillary artery.New balloon catheter was placed.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB WITH ACCESSORIES
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• MDR Report Key: 9948139
• MDR Text Key: 187203790
• Report Number: 9948139
• 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: 04/06/2020,04/02/2020

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: 0684-00-0576-01U
• Device Catalogue Number: 0684-00-0576-01U
• Device Lot Number: 3000117020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27010 DA