MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number CS 300

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 07/05/2019

Event Type  malfunction  

Event Description

Around 0645 patient's bp's started to drop on iabp.Started increasing levophed.At 0655 there was an alarming leak in circuit.Upon assessment scant amount of blood noted in the tubing.Drs.Paged stat as iabp alarming leak in iab circuit.Dr.Arrived in timely.A lot of blood noted in tubing by the time md arrived.Iabp removed.Manufacturer response for fiber-optic balloon catheter, and insertion kit, maquet (per site reporter).Pending further contact from service rep.

• Brand Name: SENSATION PLUS
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law dr; fairfield NJ 07004
• MDR Report Key: 8935413
• MDR Text Key: 155669264
• Report Number: 8935413
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS 300
• Device Catalogue Number: 0684-00-0568-01U
• Device Lot Number: 3000094740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2019
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1