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

Catalog Number 0998-00-0800-XX

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 09/10/2016

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for the iabp involved in the event was reviewed. There were no non-conformances in the dhr related to the reported event. The service representative observed fault code # 37 (autofill failure) and the reported "gas loss in iab circuit" alarm however was unable to duplicate the reported issue. Unrelated to the event, it was also reported that the service representative replaced the safety disk (part #: 0202-00-0140) that was past due for replacement per the preventive maintenance by factory specification. The iabp was tested to factory specification. It functioned normally and was returned to the customer. The manufacture evaluated the fault logs and concluded that the recorded alarms are consistent with iab catheter failures however it is not possible to evaluate the iab catheter because the customer discarded it. The manufacture also evaluated pictures of the solid white line/"white balk" and determined that is the time in standby area that will appear whenever the iabp has assisted and then has been put in standby either manually by the user or automatically by a high priority alarm as reported in the event description.

Event Description

The customer reported: patient was put on intra-aortic balloon pump (iabp) therapy due to weak heart circulation after having aorto-coronary bypass surgery and aortic valve replacement. During iabp therapy, the iabp generated an "air leakage" alarm ("gas loss in iab circuit"). Along with the alarm, a solid white line/"white balk" appeared on the display. The caregivers checked the iab with a syringe to make sure that was no blood or leaks inside the iab tubing. The caregivers also verified the iab position with x-ray and checked there were no blood clots by transesophageal echocardiography (tee). The patient¿s health status deteriorated and the caregivers made the decision to stop therapy. Shortly after the discontinuation of therapy, the patient died. The patient death per the caregivers, was not attributed to the iabp.

• 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: 6015695
• MDR Text Key: 56913567
• Report Number: 2249723-2016-00030
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 0998-00-0800-XX
• Other Device ID Number: CA243285C4
• 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: 09/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 10/10/2016 Patient Sequence Number: 1