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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 Problems Restricted Flow rate (1248); Optical Problem (3001)
Patient Problem Death (1802)
Event Date 10/16/2020
Event Type  Death  
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.Complaint record id # (b)(4).
 
Event Description
It was reported that intra-aortic balloon(iab) therapy was provided for approximately 12 hours without issue prior to patient going into surgery.During bypass case, the cardiosave balloon pump was placed in semi auto mode, internal trigger, and 1 to 3 frequency.After the procedure lasting approximately 2.5 hours, the cardiosave unit was placed back into auto mode and frequency placed to 1 to 1.The pump alarmed "catheter restriction and fiber optic sensor failure".The clinician reported that they performed a iab fill and pressed start only to have the messages repeat of catheter restriction and fiber optic sensor failure.The customer reported that they then prepared to replace the catheter and obtained another 50cc sensation plus for insertion.The surgeon attempted to insert the guide wire into the catheter and met resistance.After numerous attempts to pass the guide wire and meeting resistance, the surgeon removed the catheter and inserted another 50cc sensation plus catheter.The patient expired later in the same day.This report is for the 1st iab used.A separate report will be submitted for the 2nd iab used.A separate report will be submitted for the cardiosave intra-aortic balloon pump(iabp).
 
Event Description
It was reported that intra-aortic balloon(iab) therapy was provided for approximately 12 hours without issue prior to patient going into surgery.During bypass case, the cardiosave balloon pump was placed in semi auto mode, internal trigger, and 1 to 3 frequency.After the procedure lasting approximately 2.5 hours, the cardiosave unit was placed back into auto mode and frequency placed to 1 to 1.The pump alarmed "catheter restriction and fiber optic sensor failure".The clinician reported that they performed a iab fill and pressed start only to have the messages repeat of catheter restriction and fiber optic sensor failure.The customer reported that they then prepared to replace the catheter and obtained another 50cc sensation plus for insertion.The surgeon attempted to insert the guide wire into the catheter and met resistance.After numerous attempts to pass the guide wire and meeting resistance, the surgeon removed the catheter and inserted another 50cc sensation plus catheter.The patient expired later in the same day.This report is for the 1st iab used.A separate report will be submitted for the 2nd iab used.A separate report will be submitted for the cardiosave intra-aortic balloon pump(iabp).
 
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.A catheter tubing kink was observed at approximately 34.3cm from the iab tip.At this same location, an optical fiber break was also observed.An underwater leak test of the balloon, catheter tubing, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded.The optical fiber was found to be broken from a kink, confirming the reported problem.However, the evaluation was not able to duplicate nor confirm the reported catheter restriction alarm.We were unable to determine how or when the kink 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).
 
Manufacturer Narrative
Correction to mfg report number: 2248146-2020-00605 to include: serial number: (b)(6).Lot#: 3000117327.Exp.Date: 03/23/2023.Manufacture date: 03/23/2020.Reference complaint#: (b)(4).
 
Event Description
It was reported that intra-aortic balloon (iab) therapy was provided for approximately 12 hours without issue prior to patient going into surgery.During bypass case, the cardiosave balloon pump was placed in semi auto mode, internal trigger, and 1 to 3 frequency.After the procedure lasting approximately 2.5 hours, the cardiosave unit was placed back into auto mode and frequency placed to 1 to 1.The pump alarmed "catheter restriction and fiber optic sensor failure".The clinician reported that they performed a iab fill and pressed start only to have the messages repeat of catheter restriction and fiber optic sensor failure.The customer reported that they then prepared to replace the catheter and obtained another 50cc sensation plus for insertion.The surgeon attempted to insert the guide wire into the catheter and met resistance.After numerous attempts to pass the guide wire and meeting resistance, the surgeon removed the catheter and inserted another 50cc sensation plus catheter.The patient expired later in the same day.This report is for the 1st iab used.A separate report will be submitted for the 2nd iab used.A separate report will be submitted for the cardiosave intra-aortic balloon pump (iabp).
 
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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 07004
MDR Report Key10829907
MDR Text Key215953458
Report Number2248146-2020-00605
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 01/26/2021
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 Date03/23/2023
Device Model Number0684-00-0576-01
Device Catalogue Number0684-00-0575
Device Lot Number3000117327
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2020
Initial Date Manufacturer Received 10/20/2020
Initial Date FDA Received11/12/2020
Supplement Dates Manufacturer Received12/31/2020
12/31/2020
Supplement Dates FDA Received12/31/2020
01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CARDIOSAVE.; CARDIOSAVE
Patient Outcome(s) Death;
Patient Age79 YR
Patient Weight83
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