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

Model Number N/A

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 05/29/2018

Event Type  malfunction  

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.(b)(6).A getinge service territory manager (stm) was dispatched to evaluate this unit and could not duplicate the issue.The unit passed all functional and safety tests per factory specifications and was returned to the customer and cleared for clinical use.

Event Description

It was reported while a getinge cardiac assist account manager (caam) was visiting the facility, it was reported to her that ¿gas loss in iab circuit¿ continued to occur during use on a patient.The representative was called to the patient¿s bedside to assist and reported that the iabp alarmed every 30-40 minutes while she was there.The representative performed complete troubleshooting.The customer had not done a chest x-ray in 2 days and the caam suggested they do so.This later verified proper placement of the intra-aortic balloon (iab).A small amount of condensation was observed in the extender tubing, and the caam and customer decided to change out pump to see if problem was likely the catheter or the iabp.However, it was at that point that the cardiologist advised that the pump was alarming the same alarm shortly after insertion and they already had changed the iabp once.At that time, the cardiologist verified the insertion site and noted that helium was moving in and out of the iab fine.He elected not to change out the iabp.The nurses were advised to manage the alarm with iab fill/start keys.Nevertheless, in spite of this direction, the nurse manager called getinge emergency line in the evening to report ongoing problem, and on the following morning, the nurse manager advised that the alarm continued during the night but much less- only alarmed twice.It was agreed that this was not an iabp problem given that the alarm - which usually is a catheter problem continued with a change to a different iabp.Customer was advised to return the catheter to getinge when it is removed from patient, but they have a process which requires them to keep it first.No adverse event was reported.A separate report was submitted for investigation of the iab.

• 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: 7630623
• MDR Text Key: 112307687
• Report Number: 2249723-2018-01067
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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?: Yes
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2018
• 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