MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0434

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 05/30/2018

Event Type  Death  

Manufacturer Narrative

The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy a "blood detected" alarm was generated which caused interruption of therapy.There was no blood seen by the clinician.The customer attempted to restart the iab pump by powering down and rebooting the system.The customer also used the help feature to troubleshoot.Therapy was reinitiated however it was interrupted for 5-6 minutes.The patient expired however the patient's death is not attributed to the device by the facility.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The extension tubing was also returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extension tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.The reported alarm, blood detected event cannot be confirmed by the evaluation.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.Complaint # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy a "blood detected" alarm was generated which caused interruption of therapy.There was no blood seen by the clinician.The customer attempted to restart the iab pump by powering down and rebooting the system.The customer also used the help feature to troubleshoot.Therapy was reinitiated however it was interrupted for 5-6 minutes.The patient expired however the patient's death is not attributed to the device by the facility.

• Brand Name: SENSATION 7FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 7648692
• MDR Text Key: 112698500
• Report Number: 2248146-2018-00409
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• 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: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2019
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000038925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 83 YR
• Patient Weight: 97