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

Catalog Number 0998-00-0800-XX

Device Problem Pumping Stopped (1503)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Ventricular Fibrillation (2130)

Event Date 02/10/2018

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.Additional information has been requested, and we will report accordingly if it becomes available.

Event Description

It was reported that while delivering intra-aortic balloon pump therapy with a cs300 to a patient, the patient coded and went into ventricular fibrillation.During this event, the iabp lost ecg trigger and stopped pumping.The patient expired during this event and the customer is requesting that the iabp be thoroughly checked out before being put back into service.No specific issue with iabp was cited.The patient's death is not being attributed to the iabp.

Manufacturer Narrative

Corrected: (catalog number to 0998-00-0800-xx and (b)(4)).A getinge (b)(4) (stm) evaluated the iabp and found no problem during his inspection.The iabp passed all functional and safety tests to factory specifications, returned to customer and cleared for clinical use.

Event Description

It was reported that while delivering intra-aortic balloon pump therapy with a cardiosave to a patient, the patient coded and went into ventricular fibrillation.During this event, the iabp lost ecg trigger and stopped pumping.The patient expired during this event and the customer is requesting that the iabp be thoroughly checked out before being put back into service.No specific issue with iabp was cited.The patient's death is not being attributed to the iabp.

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.

Event Description

It was reported that while delivering intra-aortic balloon pump therapy with a cardiosave to a patient, the patient coded and went into ventricular fibrillation.During this event, the iabp lost ecg trigger and stopped pumping.The patient expired during this event and the customer is requesting that the iabp be thoroughly checked out before being put back into service.No specific issue with iabp was cited.The patient's death is not being 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: 7328523
• MDR Text Key: 102063427
• Report Number: 2249723-2018-00389
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-0800-XX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2012
• 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): Death