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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0576-01
Device Problem Inability to Auto-Fill (1044)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/22/2022
Event Type  Death  
Manufacturer Narrative
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
It was reported that during intra-aortic balloon (iab) therapy, the cardiosave intra-aortic balloon pump (iabp) unit alerted an autofill failure alarm.They tried to initiate autofill and received same failure.They attempted manual fill a few times, but it did not work.Customer called esp number on pump and spoke to answering service.While waiting for return call the staff ended up moving to impella after non successfully resolving pump issue.Customer reported not seeing any blood in pump but noted that inhouse biomed thought there was blood in the pump.Biomed noted that there was no blood in the pump but some blood on outside of pump.Getinge service tech was not called.A portage in-house biomed attended to pump.Patient died but customer noted they did not think this was a result of the balloon pump failure.The patient was not moved when the error occurred, however the patient did sit up while the iab was in place.The customer did not believe there was a kink because the iab pump was working without alarm initially, there was enough helium in the tank.Position of the iab was confirmed multiple times while patient was on the table with dr.(b)(6).The patient never made it off the table.Patient went into vfib (ventricular fibrillation) with multiple shocks, impella was then placed and patient went into pea (pulseless electrical activity) with multiple rounds of cpr, but patient expired.The status of the patient from the beginning was critical.The patient did make some improvement once iabp was placed and tvp (temporary transvenous pacing) was placed, but then the patient declined and continue to decline even after the impella was placed.This report is for the iab.A separate report has been submitted for the cardiosave iabp under mfg report number 2249723-2022-02917.
 
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint # (b)(4).
 
Event Description
N/a.
 
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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
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
brian schaeffer
15 law drive
fairfield, NJ 
MDR Report Key15846794
MDR Text Key304166274
Report Number2248146-2022-00901
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108605
UDI-Public10607567108605
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/20/2023
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 Date04/14/2023
Device Model Number0684-00-0576-01
Device Catalogue Number0684-00-0575
Device Lot Number3000118913
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/01/2022
Initial Date FDA Received11/22/2022
Supplement Dates Manufacturer Received03/20/2023
Supplement Dates FDA Received03/20/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/14/2020
Is the Device Single Use? Yes
Type of Device Usage A
Patient Sequence Number1
Treatment
IMPELLA CARDIOSAVE / 21CH247722L
Patient Outcome(s) Death;
Patient Age50 YR
Patient SexFemale
Patient Weight52 KG
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