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

Catalog Number 0684-00-0575

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 07/31/2020

Event Type  Death  

Manufacturer Narrative

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 use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a gas gain error.The iabp was swapped for another console to continue therapy.The intra-aortic balloon(iab) was removed after few hours for comfort care.The patient later expired.There was no reported malfunction on the iab.A separate report will be sent for the iabp involved.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a gas gain error.The iabp was swapped for another console to continue therapy.The intra-aortic balloon(iab) was removed after few hours for comfort care.The patient later expired.There was no reported malfunction on the iab.A separate report will be sent for the iabp involved.

Manufacturer Narrative

Additional information section d - unique identifier (udi) # from: [blank] to: (b)(4).Section h - evaluation method codes added: historical data analysis; 4109.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.Reference complaint #(b)(4).

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10476939
• MDR Text Key: 205120002
• Report Number: 2248146-2020-00446
• 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: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE; CARDIOSAVE
• Patient Outcome(s): Death
• Patient Age: 63 YR
• Patient Weight: 77