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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
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).
 
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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 Key10816933
MDR Text Key215516528
Report Number2248146-2020-00598
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K041281
Number of Events Reported1
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 Number0684-00-0474
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/15/2020
Initial Date FDA Received11/10/2020
Supplement Dates Manufacturer Received12/05/2020
02/05/2021
Supplement Dates FDA Received12/23/2020
02/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CARDIOSAVE / CH316036L9; CARDIOSAVE / CH316036L9
Patient Outcome(s) Death;
Patient Age64 YR
Patient Weight63
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