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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8 FR. 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8 FR. 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0576-01
Device Problem Optical Problem (3001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2020
Event Type  malfunction  
Manufacturer Narrative
Additional initial reporter name: (b)(6).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 a fiber optic sensor failure alarm.The console was swapped out with an alternative, but after approximately four hours the fiber optic sensor failed.The customer then used the transduced inner lumen to obtain the arterial pressure tracing to the pump and was able to successfully level and zero.There was no patient harm or adverse event reported.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated a fiber optic sensor failure alarm.The console was swapped out with an alternative, but after approximately four hours the fiber optic sensor failed.The customer then used the transduced inner lumen to obtain the arterial pressure tracing to the pump and was able to successfully level and zero.There was no patient harm or adverse event reported.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded with traces of blood on the exterior of the catheter and between the catheter and the returned maquet sheath.Two catheter tubing/inner lumen kinks were observed near the y-fitting at approximately 74.4cm & 76.2cm from the iab tip.Additionally, an optical fiber break was also observed at approximately 66.3cm from the iab tip an underwater leak test of the balloon, catheter tubing, y-fitting, extracorporeal tubing and pressure tubing was performed and no leaks were detected.The optical fiber was found broken, confirming the reported problem.However, we are unable to determine how or when this may have occurred.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint #(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated a fiber optic sensor failure alarm.The console was swapped out with an alternative, but after approximately four hours the fiber optic sensor failed.The customer then used the transduced inner lumen to obtain the arterial pressure tracing to the pump and was able to successfully level and zero.There was no patient harm or adverse event reported.
 
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.Reference complaint # (b)(4).
 
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Brand Name
SENSATION PLUS 8 FR. 50CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key11101291
MDR Text Key228037885
Report Number2248146-2020-00704
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108605
UDI-Public10607567108605
Combination Product (y/n)N
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/19/2023
Device Model Number0684-00-0576-01
Device Catalogue Number0684-00-0575
Device Lot Number3000115025
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2021
Date Manufacturer Received02/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CARDIOSAVE.
Patient Age73 YR
Patient Weight91
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