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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 Inflation Problem (1310); Gas/Air Leak (2946)
Patient Problems Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2021
Event Type  Injury  
Manufacturer Narrative
Additional reporter: (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 indicated that gas loss had occurred.The customer decided to remove the iab and replace it with a new one.There was no patient harm or adverse event reported.
 
Event Description
N/a.
 
Manufacturer Narrative
Despite request and/ or customer indicated that the device would be returned; however, the device has not been returned to the manufacturer so we are unable to complete an evaluation.The device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.The review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.The overall 24 month product complaint trend data for the period may-19 through apr-21 was reviewed.There were no triggers identified for the review period.Communication/interviews were performed to obtain all possible information.Reference complaint # (b)(4).
 
Manufacturer Narrative
Additional reporter: (b)(6) / other health care professional.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 indicated that gas loss had occurred.The customer decided to remove the iab and replace it with a new one.There was no patient harm or adverse event reported.Medwatch mw5100645 received 27-april-2021.Event description from medwatch - balloon pump alarm noted "no gas" and noted to not be inflating.All connections secure, no external evidence of leakage.Rn and charge rn at bedside.Md to bedside and requested another balloon for exchange of device.Upon removal of previously implanted balloon, noted to have large hole.Balloon placed in biohazard bag and saved as evidence of equipment failure.Patient remained generally hemodynamically stable.Although there was a significant drop in sbp while balloon out.Patient required emergent bedside surgery to repair femoral artery.Patient is a (b)(6) year old lady with no previous cardiac history.She present today for chest discomfort, dyspnea on exertion.She started noticing dyspnea exertion, chest discomfort when she was walking around 1 week ago.Denies resting symptoms, no orthopnea, no pnd, no presyncope or syncope.She went to see her pcp earlier today as scheduled.An ekg was done, which was concerning for acute coronary syndrome.She was sent to emergency room immediately.She is resting without distress when i saw her.No chest pain, no chest pressure, no orthopnea, no pnd.Her ekg showed st depression, but no indication of stemi.She has been hemodynamics stable.Troponin is mildly elevated.Fda safety report id # (b)(4).
 
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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
MDR Report Key11706128
MDR Text Key246702019
Report Number2248146-2021-00251
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 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/10/2023
Device Model Number0684-00-0576-01
Device Catalogue Number0684-00-0575
Device Lot Number3000131135
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/30/2021
Patient Sequence Number1
Treatment
CARDIOSAVE / (21)CH331452L0
Patient Outcome(s) Required Intervention;
Patient Age70 YR
Patient Weight80
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