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

Catalog Number 0684-00-0575

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

Complete initial reporter name: (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the console generated multiple autofill failure alarms.The user then began to initiate iab fill which was ultimately successful, but eventually the same alarm was generated.The user had swapped out the console earlier for the same issue.There was no reported injury to the patient.

Manufacturer Narrative

Additional information.Evaluation method codes (4): 4109.Complaint # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the console generated multiple autofill failure alarms.The user then began to initiate iab fill which was ultimately successful, but eventually the same alarm was generated.The user had swapped out the console earlier for the same issue.There was no reported injury to the patient.

• Brand Name: SENSATION PLUS 8FR. 50CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10227401
• MDR Text Key: 198552607
• Report Number: 2248146-2020-00322
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

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: 10/17/2022
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000106672
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 87