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

Catalog Number 0998-00-0800-53

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

The device history record (dhr) for the iabp involved in the event was reviewed.There were no non conformances noted in dhr related to the reported event.The company representative was unable to duplicate the reported problem however he observed on the fault logs fault code#53 (dc proxy overrun detected software performance error).He reloaded the system software.The iabp was tested to factory specification.It functioned normally and was returned to the customer.

Event Description

Customer reported: during coronary artery bypass graft x3 with left internal mammary artery an intra-aortic balloon pump (iabp) was used.Further, via fda mw report 5065066 received with the company on october 11, 2016 with regards to the same event; the customer reported the balloon pump stopped working and the patient's blood pressure went down.The patient was switched to another iabp and therapy was completed with no reports of any adverse event to the patient.

• Brand Name: CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP)
• 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: 6080792
• MDR Text Key: 59220988
• Report Number: 2249723-2016-00034
• 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
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-0800-53
• Other Device ID Number: CA241760B4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/04/2016
• Date Device Manufactured: 02/01/2014
• 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 Outcome(s): Life Threatening