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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
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.
 
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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 Key12379323
MDR Text Key268531402
Report Number2248146-2021-00555
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567109718
UDI-Public10607567109718
Combination Product (y/n)N
Number of Events Reported1
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 Date05/04/2023
Device Model Number0684-00-0480-07
Device Catalogue Number0684-00-0475
Device Lot Number3000119428
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/03/2021
Initial Date FDA Received08/27/2021
Supplement Dates Manufacturer Received08/30/2021
09/22/2021
Supplement Dates FDA Received09/20/2021
09/22/2021
Patient Sequence Number1
Treatment
CARDIOSAVE / CB335613D1.; CARDIOSAVE / CB335613D1
Patient Outcome(s) Death;
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