MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0474

Device Problems Inflation Problem (1310); Defective Device (2588); Device Displays Incorrect Message (2591)

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

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

Initial distributor reporting event is reported as: chen (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).

Event Description

It was reported that during iab (intra-aortic balloon) therapy, after the balloon was inserted in the artery, the console did not initiate pumping and alarmed "autofill failure".The doctor doutbed that the iab catheter was defective.It was replaced to initiate therapy.There was no reported injury to the patient.

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 iab (intra-aortic balloon) therapy, after the balloon was inserted in the artery, the console did not initiate pumping and alarmed "autofill failure".The doctor doutbed that the iab catheter was defective.It was replaced to initiate therapy.There was no reported injury to the patient.

Event Description

It was reported that during iab (intra-aortic balloon) therapy, after the balloon was inserted in the artery, the console did not initiate pumping and alarmed "autofill failure".The doctor doubted that the iab catheter was defective.It was replaced to initiate therapy.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and no blood was observed on the iab 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 auto fill cycle.The iab pumped normally and no alarm sounded from the pump.The reported alarm, auto fill failure 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.(b)(4).

• Brand Name: LINEAR 7.5 FR. 34CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 7319817
• MDR Text Key: 101987384
• Report Number: 2248146-2018-00147
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2020
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 30000531600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Device Age: YR
• Initial Date Manufacturer Received: 02/09/2018
• Initial Date FDA Received: 03/07/2018
• Supplement Dates Manufacturer Received: 03/09/2018; 04/10/2018
• Supplement Dates FDA Received: 03/30/2018; 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 50