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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Material Twisted/Bent (2981); Noise, Audible (3273)
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.A getinge service territory manager (stm) was dispatched to evaluate the iabp.The stm confirmed mutable autofill failures in the log files.While running performance and leak test, the iabp noticed that the average vacuum was reading below 176psi, indicating that the compressor/pump motor might be the cause.The stm observed that the iabp was almost at 9000hrs with no indication if the 5000 hr pm kit was ever installed.The facility's biomedical engineer (biomed) indicated that they replaced the 2500hr kit; but the iabp continued giving autofill failures.The stm recommended performing the 5000hr pm, and indicated that there was a possibility that the unit could have a slight leak on the vacuum side that could have been caused when the helium yoke assembly was replaced by the biomed.Customer has elected to effect the repairs themselves, and will share any other issues or resolutions for our complaint tracking.The stm did not clear the unit for clinical use, and it has not yet been confirmed if the iabp was successfully repaired.A supplemental report will be submitted.(b)(6).
 
Event Description
It was reported that the helium yoke of the cs300 intra-aortic balloon pump (iabp) was damaged (bent), and after customer made the repairs on their own, they thought the unit was "running rough" and it was also making strange sounds.It is unknown under which circumstances this event occurred or if there was any patient involvement; however there was no adverse event reported.
 
Manufacturer Narrative
The facility's biomedical engineer (biomed) rebuilt the compressor with a 2500 and later a 5000hr pm kit, but the problem continued.The biomed also replaced the drive manifold too, without any changes in the problem.At this point, the biomed requested getinge service and a purchase order was issued.The getinge service territory manager (stm) arrived and confirmed the reported problem - double checked the biomed's work and to be safe, rebuilt the compressor with another 5000hr kit.However, the problem remained.High avg vacuum recorded in addition stm noted that the vacuum recovery time was greater than 10 seconds.The stm conferred with other stms and swapped the following components with no results.Double-checked all connections - but still couldn't find any cracks or leaks.The stm ordered the drive manifold again, rebuilt the compressor and the fill manifold again, but still no positive results.At the recommendation of another stm lead, the stm was going to replace the compressor and that's when he noticed one of the vacuum quick disconnect fittings fell apart while trying to remove the compressor.There is no way of knowing for sure when the vacuum connector was damaged - either during initial assembly it might have been over-tightened or it could have possibly been damaged/stressed during a compressor rebuild.The stm replaced "all" quick disconnect fittings and retested and then performed all functionality tests and validated calibration.The iabp was released to the customer and cleared for clinical use.In addition, the stm has advised that the biomed recanted and states that the iabp does not sound any different than their other iabps.
 
Event Description
It was reported that the helium yoke of the cs300 intra-aortic balloon pump (iabp) was damaged (bent), and after customer made the repairs on their own, they thought the unit was "running rough" and it was also making strange sounds.It is unknown under which circumstances this event occurred or if there was any patient involvement; however there was no adverse event reported.
 
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Brand Name
CS300
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key8710047
MDR Text Key151915899
Report Number2249723-2019-00973
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,user f
Type of Report Initial,Followup
Report Date 09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 05/22/2019
Initial Date FDA Received06/18/2019
Supplement Dates Manufacturer Received08/22/2019
Supplement Dates FDA Received09/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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