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

Model Number N/A

Device Problems Leak/Splash (1354); Failure of Device to Self-Test (2937)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2018

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 getinge 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.The fse evaluated the iabp unit and performed four safety disk leak tests in system diagnostics with the customer's luer plug; and it passed the test every time with no failures.The fse was unable to duplicate the safety disk leak test failures.The iabp unit passed all functional, safety, and electrical safety tests to factory specifications.The unit was cleared for clinical use and returned to the customer.(b)(4).

Event Description

It was reported that during daily checks of the cs300 intra-aortic balloon pump (iabp), it intermittently failed the safety disk leak test.After the failure, the customer ran the test again and it passed.The customer reported that they perform this test every day, which is optional.There was no patient involvement or adverse event reported.

• Brand Name: CS300
• 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 Key: 7675445
• MDR Text Key: 113876088
• Report Number: 2249723-2018-01148
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2018

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 Number: N/A
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2003
• 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