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

Model Number N/A

Device Problems Display or Visual Feedback Problem (1184); Failure to Calibrate (2440)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2018

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 field service engineer (fse) was dispatched to the customer's site. The fse performed fiber optic test upon arrival, and the iabp passed the initial fiber optic test. The fse cleaned the fiber optic assembly, and re-tested the iabp; no significant difference in test results. After physical inspection of the iabp, the fse found the customer's pressure cable tight and not completely seated into the pressure port. The fse suspect the customer's issue was due to a not fully seated pressure cable. The fse then performed all functional and safety checks to meet factory specifications. Unit passed all functional and safety test per factory specifications. The iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that while attempting to set-up a patient with a fiber optic sensation 7fr 40cc to the cs300 intra-aortic balloon pump (iabp), the iabp generated a message stating unable to calibrate. The customer tried with two different iabps and they received the same error message. They brought another iabp from cardiac catheterization lab (ccl) and there was able to get it to calibrate. The first two pumps were sent to the bio-med and awaiting for evaluation. This report is for the second iabp used. No patient injury or 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: 7879679
• MDR Text Key: 120526147
• Report Number: 2249723-2018-01604
• 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: 09/14/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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

Was the Report Sent to FDA?

• Device Age: YR
• Event Location: No Information
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse