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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Break (1069); Decrease in Pressure (1490); Material Puncture/Hole (1504); Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.At this time, the customer has not requested getinge to evaluate the iabp.Additional information has been requested from the customer with regard to the repair and status of the iabp and a supplemental report will be sent if this information is provided to us.(b)(6).
 
Event Description
The following was reported to us via medwatch from the customer: the cs100 intra-aortic balloon pump (iabp) monitoring pressure decreased to 40s, while the iabp was inflating and deflating.A puncture was noted in solution on pressure device, and this was clamped off, but it was also noted that after changing the bag and re-inflating there was no augmented pressure and wave form.The customer attempted to dry an area of the pump with a small towel, and the iabp fill cable broke and piece became stuck in the clear tubing and was unable to reconnect.At this point, customer had to manually inflate and deflate the balloon pump.Subsequently, the iabp was replaced with a new one to continue patient therapy, and after the iabps were changed out , it was found that the iabp pressure monitoring line had clotted off.A new arterial line was started for monitoring of augmented pressure.There was no harm to the patient.
 
Manufacturer Narrative
The customer has advised that the iabp's fill port had been broken off, and that the iabp was brought into their biomed shop, where it was repaired, and returned to clinical service.
 
Event Description
The following was reported to us via medwatch from the customer: the cs100 intra-aortic balloon pump (iabp) monitoring pressure decreased to 40s, while the iabp was inflating and deflating.A puncture was noted in solution on pressure device, and this was clamped off, but it was also noted that after changing the bag and re-inflating there was no augmented pressure and wave form.The customer attempted to dry an area of the pump with a small towel, and the iabp fill cable broke and piece became stuck in the clear tubing and was unable to reconnect.At this point, customer had to manually inflate and deflate the balloon pump.Subsequently, the iabp was replaced with a new one to continue patient therapy, and after the iabps were changed out , it was found that the iabp pressure monitoring line had clotted off.A new arterial line was started for monitoring of augmented pressure.There was no harm to the patient.
 
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Brand Name
CS100
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key7446917
MDR Text Key106251177
Report Number2249723-2018-00668
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 05/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-3013-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Device AgeYR
Date Manufacturer Received04/02/2018
Date Device Manufactured01/01/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age65 YR
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