MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0480-07

Device Problem Pressure Problem (3012)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/03/2021

Event Type  Death  

Manufacturer Narrative

Complete event site 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 cardiosave intra-aortic balloon pump (iabp) generated no pressure source available alarm and was not showing the correct pressures.The getinge representative advised user to check inner lumen for any obstruction / clot /able to aspirate blood.User told everything seems to be ok , then it was advised to replace transducer.While replacing transducer user came to know that they forgot to open 3 way stop cock at patient end which has resulted this problem.As soon as they opened the 3 way stop cock and done zeroing , unit was found working properly.It was later reported on 06august2021 that the patient had expired on (b)(6) 2021.This report is for the iab.A separate report will be submitted for the cardiosave iabp.

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period aug-2019 through jul-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).H3 other text : device not returned.

Manufacturer Narrative

Additional information - device available for eval changed from yes to no , lot#, exp.Date, manufacture date, type of investigation (device discarded 4115).The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id#: (b)(4).

Event Description

N/a.

• Brand Name: LINEAR 7.5 FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• MDR Report Key: 12379323
• MDR Text Key: 268531402
• Report Number: 2248146-2021-00555
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567109718
• UDI-Public: 10607567109718
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2023
• Device Model Number: 0684-00-0480-07
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000119428
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 08/30/2021; 09/22/2021
• Supplement Dates FDA Received: 09/20/2021; 09/22/2021
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE / CB335613D1.; CARDIOSAVE / CB335613D1
• Patient Outcome(s): Death