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

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.

• 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: 6685912
• MDR Text Key: 79144926
• Report Number: 2249723-2017-00047
• 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: 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 Received: 07/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 0998-00-3023-53
• 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: 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage