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

Model Number N/A

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.The customer¿s biomed observed a ¿leak in iab circuit¿ message and performed the safety disk leak test multiple times; however, iabp unit failed continuously even after the tubes were replaced.A service call was placed for a getinge service territory manager (stm) to investigate.The getinge stm arrived on site and tested the iabp unit with a trainer and balloon.The stm observed the ¿leak in iab circuit¿ message after twenty minutes of operation.The stm tested for leaks but the iabp unit passed all tests to factory specifications.The stm checked the atmospheric, drive, and shuttle transducer calibrations and observed the shuttle transducer was out of calibration.The stm calibrated the shuttle transducer then retested the iabp unit, but a false ¿leak in iab circuit¿ message flashed on the screen.The stm isolated the issue to a contaminated condensation removal module (crm) and safety disk and ordered replacement parts.The stm returned at a later date to install the new crm and safety disk then performed all safety, functionality, and calibration checks which passed to factory specifications.Subsequently, the iabp unit was ran for sixty minutes on a demo balloon with no ¿leak in iab circuit¿ messages generated.The iabp unit was then cleared for use and returned to the customer for service.

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had a monitor related issue.It was later clarified that the initial issue was not monitor related and that the iabp unit continuously emitted ¿leak in iab circuit¿ alarms.The unit was sent to the biomed for evaluation.There was no patient harm; thus, no adverse event reported.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 8505996
• MDR Text Key: 142524311
• Report Number: 2249723-2019-00572
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/11/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1