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

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.

• 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: 8190822
• MDR Text Key: 131333555
• Report Number: 2249723-2018-02202
• 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: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• 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
• Date Manufacturer Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2001
• 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