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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 Leak/Splash (1354)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/19/2022
Event Type  Death  
Manufacturer Narrative
Additional initial reporter name & occupation - (b)(6), icu rn.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 blood was seen within the helium tubing.The customer was advised to stop therapy immediately and call the physician to remove the balloon within 30 minutes due to risk of thrombus.Upon follow up on (b)(6) 2022 at 8:44am, it was discovered that the physician ordered the staff to continue running the iab despite the instructions for use (ifu) stating to stop therapy and remove the iab.At 11:15am, received word from the local team that the physician elected not to remove the iab due to risk of thrombosis.Due to the patient¿s clinical condition, the team felt he would not tolerate being under anesthesia for a vascular procedure thus the iab was not removed.The patient was put on comfort care.At 1:43pm, received word from the local team that the patient expired with the iab in place as it was unable to be removed safely.
 
Event Description
N/a.
 
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint#: (b)(4).
 
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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 Key16095587
MDR Text Key306624578
Report Number2248146-2023-00013
Device Sequence Number1
Product Code DSP
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 04/11/2023
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 Model Number0684-00-0576-01
Device Catalogue Number0684-00-0575
Device Lot Number3000255396
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/19/2022
Initial Date FDA Received01/04/2023
Supplement Dates Manufacturer Received04/11/2023
Supplement Dates FDA Received04/11/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/23/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CARDIOSAVE / CH342371J1.
Patient Outcome(s) Death;
Patient Age86 YR
Patient SexMale
Patient Weight95 KG
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