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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0567
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2018
Event Type  malfunction  
Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).
 
Event Description
It was reported that while supporting patient in intensive carte unit (icu) the fiber optic sensor stopped working.Switched to a central lumen for pressure source after aspiration of catheter.The customer lost the fiber optic signal and encountered poor transduced pressure from the central lumen.The emergency service representative instructed them to aspirate about 5cc¿s of blood, flush, and standby for 30 seconds.The waveform improved and the flush procedure was repeated.The customer was informed to perform the flush every 15 minutes for 15 seconds.The patient was on hypothermia therapy.There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter and partially covering half of the balloon.The extracorporeal tubing was cut into 2 pieces and the male luer side was not returned.An underwater leak test of the balloon, catheter and y-fitting was performed and no leaks were detected.The technician attempted to insert the returned 0.025¿ guide wire through the inner lumen and was able to successfully insert the guide wire.No obstructions were felt.A sensor output test was performed and the sensor was found to be within specification.The reported sensor failure & difficult/unable to monitor pressure (through inner lumen) events cannot be confirmed by the evaluation.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.(b)(4).
 
Event Description
It was reported that while supporting patient in intensive carte unit (icu) the fiber optic sensor stopped working.Switched to a central lumen for pressure source after aspiration of catheter.The customer lost the fiber optic signal and encountered poor transduced pressure from the central lumen.The emergency service representative instructed them to aspirate about 5cc¿s of blood, flush, and standby for 30 seconds.The waveform improved and the flush procedure was repeated.The customer was informed to perform the flush every 15 minutes for 15 seconds.The patient was on hypothermia therapy.There was no reported injury to the patient.
 
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Brand Name
SENSATION PLUS 7.5FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key7648597
MDR Text Key112862226
Report Number2248146-2018-00407
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 08/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/15/2019
Device Catalogue Number0684-00-0567
Device Lot Number3000041634
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2018
Is the Reporter a Health Professional? Yes
Device AgeYR
Initial Date Manufacturer Received 06/06/2018
Initial Date FDA Received06/28/2018
Supplement Dates Manufacturer Received07/23/2018
Supplement Dates FDA Received08/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age51 YR
Patient Weight57
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