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

Model Number N/A

Device Problem Leak/Splash (1354)

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

Event Date 11/24/2017

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) evaluated the iabp and was unable to reproduce the reported "air leak" issue.However, the fse reported that the iabp¿s diagnostic error log revealed "gas loss in iab circuit", so the fse performed a full pneumatic leak test, calibration, performance, and safety tests.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 and cleared for clinical service.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) a constant air leak was noted.No patient harm or serious injury reported and no adverse event was reported.

• Brand Name: CARDIOSAVE
• 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: 7130666
• MDR Text Key: 95804972
• Report Number: 2249723-2017-01013
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• 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: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• 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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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