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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0470-01
Device Problems Off-Label Use (1494); Gas Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2021
Event Type  malfunction  
Manufacturer Narrative
Complete event site name: university of (b)(6) hospital. Complete initial reporter name: (b)(6). Additional reporter name: (b)(6) 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, the console generated three gas loss alarms within 10 minutes. The insertion was reported to be axillary, which is not the method described in the device instructions for use. There was no blood in the helium tubing and no visible kinks before the insertion site. The customer also reported that the console indicated a catheter restriction several times. The console was pumping alarm-free at the time of the call. The customer was advised to do use the "iab fill" key and/or drop the augmentation level. It was later reported via follow-up call that the patient has had three axillary iabs inserted as they are awaiting heart and kidney transplant. The patient was very mobile. During the call, the customer had to attend to them several times to have them get back in bed. The customer was again made aware of the off-label use and advised they would be troubleshooting from a femoral approach. The positional nature of the alarms was reviewed, it was verified that there was no blood in helium tubing, and connections secure on every occasion. The was no patient harm or adverse event reported.
 
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Brand NameSENSATION 7FR. 40CC IAB
Type of DeviceSYSTEM, 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 Key12573883
MDR Text Key274747839
Report Number2248146-2021-00648
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0470-01
Device Catalogue Number0684-00-0434
Device Lot Number3000132630
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/11/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/23/2020
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/04/2021 Patient Sequence Number: 1
Treatment
CARDIOSAVE
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