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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0434
Device Problems Occlusion Within Device (1423); Failure to Advance (2524); Device Displays Incorrect Message (2591)
Patient Problem Blood Loss (2597)
Event Date 01/05/2018
Event Type  Injury  
Manufacturer Narrative
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.(b)(4).
 
Event Description
It was reported by the customer that during intra-aortic balloon (iab) therapy there was a rapid gas loss alarm generated.The rn (registered nurse) caring for the patient if there was asked if there was any visible blood in the helium line.She said that there had not been but there is now.Also it was stated by the rn that in the or there was blood noted in the tubing and tubing was changed out.At the time the iab pump (iabp) was still functioning and the rn was told to place the pump in standby, to discontinue therapy and notify the physician that the iab need to be removed within 30 minutes of discontinuation of the pump.During a follow up call to the rn mentioned in addition to the pump not being placed in standby while patient was in the or he wasn¿t sure if the dark colored substance in the helium tubing was blood or a dark oil.I reinforced that if there is anything in the helium line discolored or dark it is a leak and it is important to stop therapy notify the physician and remove or switch out the catheter.A facility medwatch (b)(4) was received by the manufacturer on january 22, 2018: intra-aortic balloon pump (iabp) was put in prior to coronary artery bypass graft (cabg) surgery.During surgery, the balloon pump console gave alarm and a small amount of blood was noticed in helium line.The line was replaced and the alarms were cleared and the iabp began to function as normal.During patient's recovery (after cabg, in cardiac care unit [ccu]), the balloon pump console again gave an alarm.The doctor was called and he decided to remove balloon.Upon removal of the balloon, the surgeon was unable to get the balloon through the sheath.The patient had to be taken to the operating room for open surgical removal.An arterial cut down was performed to remove the balloon, and "rock hard" clotted blood was found inside the balloon that was keeping it from deflating.The balloon was sent to pathology for evaluation.
 
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 # (b)(4)., record # (b)(4).
 
Event Description
It was reported by the customer that during intra-aortic balloon (iab) therapy there was a rapid gas loss alarm generated.The rn (registered nurse) caring for the patient if there was asked if there was any visible blood in the helium line.She said that there had not been but there is now.Also it was stated by the rn that in the or there was blood noted in the tubing and tubing was changed out.At the time the iab pump (iabp) was still functioning and the rn was told to place the pump in standby, to discontinue therapy and notify the physician that the iab need to be removed within 30 minutes of discontinuation of the pump.During a follow up call to the rn mentioned in addition to the pump not being placed in standby while patient was in the or he wasn¿t sure if the dark colored substance in the helium tubing was blood or a dark oil.I reinforced that if there is anything in the helium line discolored or dark it is a leak and it is important to stop therapy notify the physician and remove or switch out the catheter.A facility medwatch (b)(4) was received by the manufacturer on january 22, 2018: intra-aortic balloon pump (iabp) was put in prior to coronary artery bypass graft (cabg) surgery.During surgery, the balloon pump console gave alarm and a small amount of blood was noticed in helium line.The line was replaced and the alarms were cleared and the iabp began to function as normal.During patient's recovery (after cabg, in cardiac care unit [ccu]), the balloon pump console again gave an alarm.The doctor was called and he decided to remove balloon.Upon removal of the balloon, the surgeon was unable to get the balloon through the sheath.The patient had to be taken to the operating room for open surgical removal.An arterial cut down was performed to remove the balloon, and "rock hard" clotted blood was found inside the balloon that was keeping it from deflating.The balloon was sent to pathology for evaluation.
 
Manufacturer Narrative
Correction: section e.1.Added event address (b)(6).(b)(4).
 
Event Description
It was reported by the customer that during intra-aortic balloon (iab) therapy there was a rapid gas loss alarm generated.The rn (registered nurse) caring for the patient if there was asked if there was any visible blood in the helium line.She said that there had not been but there is now.Also it was stated by the rn that in the or there was blood noted in the tubing and tubing was changed out.At the time the iab pump (iabp) was still functioning and the rn was told to place the pump in standby, to discontinue therapy and notify the physician that the iab need to be removed within 30 minutes of discontinuation of the pump.During a follow up call to the rn mentioned in addition to the pump not being placed in standby while patient was in the or he wasn¿t sure if the dark colored substance in the helium tubing was blood or a dark oil.I reinforced that if there is anything in the helium line discolored or dark it is a leak and it is important to stop therapy notify the physician and remove or switch out the catheter.A facility medwatch 1900450000-2018-8001 was received by the manufacturer on (b)(6), 2018: intra-aortic balloon pump (iabp) was put in prior to coronary artery bypass graft (cabg) surgery.During surgery, the balloon pump console gave alarm and a small amount of blood was noticed in helium line.The line was replaced and the alarms were cleared and the iabp began to function as normal.During patient's recovery (after cabg, in cardiac care unit [ccu]), the balloon pump console again gave an alarm.The doctor was called and he decided to remove balloon.Upon removal of the balloon, the surgeon was unable to get the balloon through the sheath.The patient had to be taken to the operating room for open surgical removal.An arterial cut down was performed to remove the balloon, and "rock hard" clotted blood was found inside the balloon that was keeping it from deflating.The balloon was sent to pathology for evaluation.
 
Manufacturer Narrative
The product was returned in 2 pieces with the membrane completely unfolded and with blood on the interior of the catheter.The orange cable was also cut into 2 pieces and one piece was not returned.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and two leaks were detected on the membrane approximately 1.3cm and 17.8cm from the rear seal measuring 0.38cm and 0.15cm in length respectively.The optical fiber was found to be broken within the catheter tubing approximately 27.4cm from iab tip.The evaluation confirms the reported alarm and blood in tubing problems.We are unable to confirm unable to remove iab from patient problem because we are unable to mimic the clinical setting.The reported alarm and blood in tubing issues were most likely triggered by the leaks which were found on the membrane.The penetrations found on the membrane appear to have been caused by a sharp object.We are unable to determine when this may have occurred.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.Complaint # ca-cpl-2018-00073, record # 156355.
 
Event Description
It was reported by the customer that during intra-aortic balloon (iab) therapy there was a rapid gas loss alarm generated.The rn (registered nurse) caring for the patient if there was asked if there was any visible blood in the helium line.She said that there had not been but there is now.Also it was stated by the rn that in the or there was blood noted in the tubing and tubing was changed out.At the time the iab pump (iabp) was still functioning and the rn was told to place the pump in standby, to discontinue therapy and notify the physician that the iab need to be removed within 30 minutes of discontinuation of the pump.During a follow up call to the rn mentioned in addition to the pump not being placed in standby while patient was in the or he wasn¿t sure if the dark colored substance in the helium tubing was blood or a dark oil.I reinforced that if there is anything in the helium line discolored or dark it is a leak and it is important to stop therapy notify the physician and remove or switch out the catheter.A facility medwatch 1900450000-2018-8001 was received by the manufacturer on (b)(6) 2018: intra-aortic balloon pump (iabp) was put in prior to coronary artery bypass graft (cabg) surgery.During surgery, the balloon pump console gave alarm and a small amount of blood was noticed in helium line.The line was replaced and the alarms were cleared and the iabp began to function as normal.During patient's recovery (after cabg, in cardiac care unit [ccu]), the balloon pump console again gave an alarm.The doctor was called and he decided to remove balloon.Upon removal of the balloon, the surgeon was unable to get the balloon through the sheath.The patient had to be taken to the operating room for open surgical removal.An arterial cut down was performed to remove the balloon, and "rock hard" clotted blood was found inside the balloon that was keeping it from deflating.The balloon was sent to pathology for evaluation.
 
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Brand Name
SENSATION 7FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key7233340
MDR Text Key98736413
Report Number2248146-2018-00061
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 07/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/03/2020
Device Catalogue Number0684-00-0434
Device Lot Number3000048410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2018
Device AgeYR
Date Manufacturer Received07/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age73 YR
Patient Weight95
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