MAUDE Adverse Event Report: GETINGE/MAQUET/DATASCOPE, INC. CATH SENSATION PLUS 40CC IABP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Lot Number 3000098713

Device Problem Backflow (1064)

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

Event Date 03/15/2020

Event Type  Injury  

Event Description

Blood backing up into the gas line of the balloon pump.Fda safety report id #: (b)(4).

• Brand Name: CATH SENSATION PLUS 40CC IABP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): GETINGE/MAQUET/DATASCOPE, INC.
• MDR Report Key: 10211809
• MDR Text Key: 197318578
• Report Number: MW5095283
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/26/2020

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: Health Professional
• Device Expiration Date: 05/06/2022
• Device Lot Number: 3000098713
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR