MAUDE Adverse Event Report: DATASCOPE FAIRFIELD BO-T 46200 CUSTOM TUBING PACK; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 701065620

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 06/22/2017

Event Type  malfunction  

Manufacturer Narrative

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.We continue our efforts to follow up with the customer for its return.(b)(4).

Event Description

Custom pack leaked during priming.

Manufacturer Narrative

08/18/2017 (b)(4): the customer returned only a section of the device.Per attached failure evaluation, the returned portion of the product was leak tested and no leak was detected.We are unable to confirm the reported event.The actual lhr review is not able to be performed since the lot number was not provided.A lot history record review was completed for the last lot shipped to the customer, lot 3000028478.No non-conformances were found that are considered to be related to the event.Complaint # (b)(4); record # 141411.

Event Description

Custom pack leaked during priming.There was no patient involvement.

• Brand Name: BO-T 46200 CUSTOM TUBING PACK
• 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: 6713718
• MDR Text Key: 80178804
• Report Number: 2248146-2017-00163
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K08059223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 701065620
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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