MAUDE Adverse Event Report: DATASCOPE FAIRFIELD BEQ-TOP 21503 ECC PACK; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 701054776

Device Problem Kinked (1339)

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

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

The product is not promised for return.As a result, we are unable to complete an evaluation.A supplemental report will be provided if new information becomes available.(b)(4).

Event Description

During initial set-up of back-up ecc circuit, it was noted that pigtails attached to connectors of ecc circuit were in an extreme "kinked" position.Pigtails were exchanged with pigtails that were not kinked.The circuit was then set-up per institution protocol and stored as back-up ecc circuit for later use.

Manufacturer Narrative

Dates were inadvertently not entered in the initial mdr.Date of this report: 12/14/2016.Manufacturer date: 11/18/2016.

Event Description

During initial set-up of back-up ecc circuit, it was noted that pigtails attached to connectors of ecc circuit were in an extreme "kinked" position.Pigtails were exchanged with pigtails that were not kinked.The circuit was then set-up per institution protocol and stored as back-up ecc circuit for later use.

• Brand Name: BEQ-TOP 21503 ECC PACK
• 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: 6174801
• MDR Text Key: 62707398
• Report Number: 2248146-2016-00096
• 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,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/10/2018
• Device Catalogue Number: 701054776
• Device Lot Number: 3000022646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2016
• Date Device Manufactured: 03/10/2016
• 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): Required Intervention