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

Catalog Number 0684-00-0434

Device Problem Device Alarm System (1012)

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

Event Date 02/14/2019

Event Type  malfunction  

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 "fiber optic sensor failure" alarm occurred shortly after startup.The iab was removed and replaced to continue therapy.There was no reported injury to the patient.

Event Description

It was reported that during intra-aortic balloon (iab) therapy a "fiber optic sensor failure" alarm occurred shortly after startup.The iab was removed and replaced to continue therapy.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and no visible blood on the catheter.- an underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.- a sensor output test was performed and the sensor was found to be within specification.- 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 evaluation was unable to duplicate the reported alarm.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint # (b)(4); record id (b)(4).

• Brand Name: SENSATION 7FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8412131
• MDR Text Key: 138957845
• Report Number: 2248146-2019-00201
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2021
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000084861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Device Age: YR
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 90