MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0474

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

Patient Problem Death (1802)

Event Date 10/15/2020

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.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the cardiosave intra-aortic balloon pump (iabp) unit had a message appear stating that fiber optic module maintenance was needed.The customer reported that a traditional fluid based catheter for pressure source was utilized.The patient was off of a major heart surgery and on extracorporeal membrane oxygenation (ecmo).The facility does not attribute the patient's death to the device.There was no reported malfunction on the iab.A separate report will be submitted for the cardiosave intra-aortic balloon pump (iabp).

Manufacturer Narrative

Additional initial reporter name/occupation - (b)(6) / registered nurse.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 cardiosave intra-aortic balloon pump (iabp) unit had a message appear stating that fiber optic module maintenance was needed.The customer reported that a traditional fluid based catheter for pressure source was utilized.The patient was off of a major heart surgery and on extracorporeal membrane oxygenation (ecmo).The facility does not attribute the patient's death to the device.There was no reported malfunction on the iab.A separate report will be submitted for the cardiosave intra-aortic balloon pump (iabp).

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.We are unable to confirm the reported event.If additional information is provided we will send a supplemental report with our additional findings.Reference complaint # (b)(4).

Event Description

It was reported that during intra-aortic balloon(iab) therapy, the cardiosave intra-aortic balloon pump (iabp) unit had a message appear stating that fiber optic module maintenance was needed.The customer reported that a traditional fluid based catheter for pressure source was utilized.The patient was off of a major heart surgery and on extracorporeal membrane oxygenation (ecmo).The facility does not attribute the patient's death to the device.There was no reported malfunction on the iab.A separate report will be submitted for the cardiosave intra-aortic balloon pump (iabp).

• Brand Name: LINEAR 7.5 FR. 34CC 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: 10816933
• MDR Text Key: 215516528
• Report Number: 2248146-2020-00598
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 12/05/2020; 02/05/2021
• Supplement Dates FDA Received: 12/23/2020; 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE / CH316036L9; CARDIOSAVE / CH316036L9
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Weight: 63