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

Catalog Number 0998-00-0800-53

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 08/20/2017

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 company standard operating procedure since the device manufacture date is greater than one year from the event date.

Event Description

The customer reported that the intra-aortic balloon pump (iabp) had a complete helium tank leak in about 10 minutes.The circumstances of the event are unknown, however, no adverse event has been reported.

Manufacturer Narrative

(b)(4) 2017 11:30 am (gmt-4:00) added by (b)(6): (b)(4) 2017 12:26 pm (gmt-4:00) added by(b)(6): a getinge field service engineer (fse) was dispatched and reported that he confirmed the helium leak that was stated by the customer.The fse found the problem to be the quick disconnect o-ring on the console.The fse replaced this o-ring and found a small leak in the high pressure transducer o-ring.The fse removed and re-greased this o-ring with vacuum grease and reinstalled it.The fse returned to the facility and the iabp was leaking helium once again.The fse troubleshot for the leak and found the leak to be in the high pressure transducer again.The fse replaced the o-ring and re-greased it with vacuum grease.After reseating this o-ring, the fse performed the leak test and the iabp passed.The fse performed functional tests, and the iabp passed all tests and calibrations.The fse released the iabp back to the customer, cleared for clinical use.

Event Description

The customer reported that the intra-aortic balloon pump (iabp) had a complete helium tank leak in about 10 minutes.This event occurred while the iabp was in use on a patient, no adverse event has been 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: 6870783
• MDR Text Key: 86621781
• Report Number: 2249723-2017-00496
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/15/2017
• Supplement Dates Manufacturer Received: 09/06/2017
• Supplement Dates FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2015
• 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
• Patient Age: 60 YR