MAUDE Adverse Event Report: DATASCOPE FAIRFIELD CUSTOM ECC PACK BEQ-TOP 50903; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 709000078

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 02/09/2018

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.Complaint # (b)(4), record: (b)(4).

Event Description

It was reported that during circuit set-up of custom ecc pack, luer access port on arterial apex side of membrane was broken off of membrane oxygenator.There was no patient involvement.

Manufacturer Narrative

The tray and packaging were not returned for review.A visual inspection was performed confirming the broken port of quadrox-id adult.The reported event was confirmed.It was determined that the most likely cause of the port being broken from the filter can be attributed to rough handling during use by the customer.A 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).

Event Description

It was reported that during circuit set-up of custom ecc pack, luer access port on arterial apex side of membrane was broken off of membrane oxygenator.There was no patient involvement.

• Brand Name: CUSTOM ECC PACK BEQ-TOP 50903
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• 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: 7320824
• MDR Text Key: 101995939
• Report Number: 2248146-2018-00146
• Device Sequence Number: 1
• Product Code: DWE
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2019
• Device Catalogue Number: 709000078
• Device Lot Number: 3000063290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2017
• 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