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

Catalog Number 0998-00-3023-53

Device Problem Device Alarm System (1012)

Patient Problem No Information (3190)

Event Date 10/08/2018

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 company standard operating procedure since the device manufacture date is greater than one year from the event date. A getinge service territory manager (stm) was dispatched to the customer's site to investigate the reported issue. The stm ran a performance test and the iabp repeatedly generated a ¿low vacuum¿ and ¿rapid gas loss¿ alarms. The stm replaced the compressor vacuum and the pressure heads and membranes as a part of the 5,000 hour rebuild. However, the vacuum alarm persisted. The stm then replaced the purge valve assembly along with the purge line, which resolved the issue. The iabp passed all functional, calibration and safety tests as per factory specifications. The iabp was returned to customer and cleared for clinical use.

Event Description

While supporting a patient with the cs300 intra aortic balloon pump (iabp) in the critical care unit (ccu), the cs300 generated several "rapid gas loss" and "low vacuum¿ alarms. All connections were secure and there was no indication of a leak. No adverse event was 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: 8026435
• MDR Text Key: 125937986
• Report Number: 2249723-2018-01886
• 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

• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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

Was the Report Sent to FDA?

• Device Age: YR
• Event Location: No Information
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse