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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
Catalog Number 0998-00-3023-53
Device Problems Burst Container or Vessel (1074); Device Displays Incorrect Message (2591); Pressure Problem (3012)
Patient Problem No Code Available (3191)
Event Date 06/14/2017
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 field service engineer (fse) was dispatched to investigate. Once the fse arrived on site and spoke with the department regarding the incident, he was told that the issue was in the pressure arterial line. The line had a clog in it which caused the saline pressure bag to burst and spill on the unit, the unit never stopped working. Once the saline was cleaned and the circuit was inspected by the nurse, it was discovered that the arterial line had the clog in it and this is what was causing the erratic pressure readings. The iabp did what it was designed to do and switched to the patient ecg for patient therapy. The iabp therapy was not interrupted and therapy was continued until completed. The fse completed internal checks for saline damage and did not find any. The fse completed checks and performance tests with no issues. Unit passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.
 
Event Description
It was reported that while the intra-aortic balloon pump (iabp) was being used on a patient, a flush bag "exploded" flooding pump. As a result, causing multiple issues including poor pressure readings; poor hemodynamics and several alarms. The iabp was swapped out and original was sent to bio-med for evaluation. No death or injury was 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 Key6685912
MDR Text Key79144926
Report Number2249723-2017-00047
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 06/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received06/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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