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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problem Aspiration Issue (2883)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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 a patient had returned to the ccl (cardiac catheterization laboratory) this morning with an intra-aortic balloon (iab) that had ¿relocated¿ in the aorta and the tip was too low.An alarm ¿optical sensor failure¿ was generated.The staff questioned whether the balloon had to be removed for the alarm and how to manage the alarm.Maquet emergency support coordinator (esc) explained that if it was possible to reposition the balloon successfully then they only needed to supply an arterial source to the pump and explained transducing the central lumen.The patient went to icu (intensive care unit) and it was reported that there was no arterial waveform.Troubleshooting by the esc revealed that the arterial lumen had been capped, it was not known when.Aspiration had to be performed and correct cable and transducer system was attached; icu staff assured the esc that the lumen was open.It was said that the cable was changed prior to contacting the esc, but there was still no waveform.The fiber optic cable was disconnected as directed.The esc explained that it was either the lumen, cable or transducer and asked the icu staff to replace the disposable; there was still no waveform after replacement.Esc instructed that they aspirate the fluid lumen which was plugged now.The icu staff called for radial line and put the pump into semiauto to eliminate the alarm for unable to update timing.There was no reported injury to the patient.
 
Manufacturer Narrative
Product was believed to be returned on 25-jan-2018.After sending for sanitization and upon return, it was determined that it was only an empty box.The product had not been returned.If provided we will send a supplemental report with our additional findings.Complaint # (b)(4), record # (b)(4).
 
Event Description
It was reported that a patient had returned to the ccl (cardiac catheterization laboratory) this morning with an intra-aortic balloon (iab) that had ¿relocated¿ in the aorta and the tip was too low.An alarm ¿optical sensor failure¿ was generated.The staff questioned whether the balloon had to be removed for the alarm and how to manage the alarm.Maquet emergency support coordinator (esc) explained that if it was possible to reposition the balloon successfully then they only needed to supply an arterial source to the pump and explained transducing the central lumen.The patient went to icu (intensive care unit) and it was reported that there was no arterial waveform.Troubleshooting by the esc revealed that the arterial lumen had been capped, it was not known when.Aspiration had to be performed and correct cable and transducer system was attached; icu staff assured the esc that the lumen was open.It was said that the cable was changed prior to contacting the esc, but there was still no waveform.The fiber optic cable was disconnected as directed.The esc explained that it was either the lumen, cable or transducer and asked the icu staff to replace the disposable; there was still no waveform after replacement.Esc instructed that they aspirate the fluid lumen which was plugged now.The icu staff called for radial line and put the pump into semiauto to eliminate the alarm for unable to update timing.There was no reported injury to the patient.
 
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Brand Name
SENSATION PLUS 8FR. 50CC 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 Key7243916
MDR Text Key99925963
Report Number2248146-2018-00078
Device Sequence Number1
Product Code DSP
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 company representative,health
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/07/2020
Device Catalogue Number0684-00-0575
Device Lot Number3000062257
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/25/2018
Is the Reporter a Health Professional? Yes
Device AgeYR
Date Manufacturer Received02/14/2018
Date Device Manufactured11/07/2017
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 Age64 YR
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