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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Inability to Auto-Fill (1044); Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 11/26/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event. A getinge field service engineer (fse) evaluated the iabp and was unable to reproduce the reported "auotfill failure and leak in iab catheter alarms" issue. However, the fse was able to verify the alarms in the iabp¿s diagnostic error log and while testing the iabp, observed that the fill port luer had plastic threads completely engaged with metal fitting on the safety disk. To fix the issue, the fse replaced the luer fitting and performed full calibration. Subsequently, it was found that the calibration was out of specifications. The fse calibrated the autofill to within specifications. The iabp was able to pass all the leak tests, and the fse performed all functional and safety checks to meet factory specifications. The iabp was then released to the customer for return to clinical service.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) had a "leak in iab catheter". It was later reported that an "autofill failure" also occurred. It is unknown the circumstances under which the event occurred. However, there was no patient involvement, and there was no adverse event reported.
 
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Brand NameCS300
Type of DeviceSYSTEM, 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 Key8190822
MDR Text Key131333555
Report Number2249723-2018-02202
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 12/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2018
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
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2001
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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