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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 Optical Problem (3001)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2022
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.Complaint record id # (b)(4).Device not returned.
 
Event Description
It was reported that shortly after inserting the intra-aortic balloon (iab), the console generated a fiber optic sensor failure message.The customer was able to connect and successfully transduce the central lumen for an arterial line prior to our call back.They were advised in possible causes for the message such as damage to the sensor, or wetness at the connection during setup.At that time, the patient was stable and being transferred to the icu.There was no patient harm or adverse event reported.
 
Manufacturer Narrative
Additional updated information: complete initial reporter name - (b)(6).Adverse event or product problem, outcome attributed to ae, describe event or problem , device available for eval?, initial reporter, type of reportable event, health effect ¿ clinical code, health effect ¿ impact codes.The device was not returned and could not be evaluated.It was not saved 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 shortly after inserting the intra-aortic balloon (iab), the console generated a fiber optic sensor failure message.The customer was able to connect and successfully transduce the central lumen for an arterial line prior to our call back.They were advised in possible causes for the message such as damage to the sensor, or wetness at the connection during setup.At that time, the patient was stable and being transferred to the icu.It was later reported that the patient did not survive and iab was not saved.
 
Manufacturer Narrative
Updated fields - event site email, describe event or problem.Complaint record id # (b)(4).
 
Event Description
It was reported that immediately after inserting the intra-aortic balloon (iab), the console generated a fiber optic sensor failure message.The fiber optic did not work from the onset of plugging it in.Therapy was started by unplugging the fiber optics and were using ecg trigger.The customer was able to connect and successfully transduce the central lumen for an arterial line prior to our call back.They were advised in possible causes for the message such as damage to the sensor, or wetness at the connection during setup.At that time, the patient was stable and being transferred to the icu.It was later reported that the patient did not survive and iab was not saved.
 
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 Key15920414
MDR Text Key306978060
Report Number2248146-2022-00940
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 Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 03/29/2023
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 Date02/05/2024
Device Model Number0684-00-0576-01
Device Catalogue Number0684-00-0575
Device Lot Number3000143119
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/15/2022
Initial Date FDA Received12/05/2022
Supplement Dates Manufacturer Received12/02/2022
12/27/2022
03/29/2023
Supplement Dates FDA Received12/20/2022
01/12/2023
03/29/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/05/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age68 YR
Patient SexMale
Patient Weight95 KG
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