MAUDE Adverse Event Report: DATASCOPE FAIRFIELD CARDIOPULMONARY TUBING PACK; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 701056869

Device Problem Infusion or Flow Problem (2964)

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

Event Date 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

Update 3/31/2016 01:34 pm (b)(4): the device was returned on 03/30/2016 but have been unable to complete an evaluation of it, when we do, we will send the additional findings in a supplemental report.(b)(4).********************************************************************************************* update 03/30/2016 03:51 pm (b)(4): the device is available however, at this time we have not received it and an evaluation was not possible.We continue to follow up with the customer regarding its' return; if and when its' received we will complete an evaluation and send you the additional findings in a supplemental report.(b)(4).

Event Description

On (b)(6) 2016 09:03 am: while priming the circuit they could not get flow through the plegiox.Nothing would exit the blood outlet.

Manufacturer Narrative

As per the investigation on the device, the evaluation confirmed the reported problem.It was determined that there was no flow through the circuit due to an incorrect luer lock being assembled to the device.No nonconformances were found that are considered to be related to the event.Complaint # (b)(4).

Event Description

While priming the circuit they could not get flow through the plegiox.Nothing would exit the blood outlet.

• Brand Name: CARDIOPULMONARY TUBING 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: 5538933
• MDR Text Key: 41907820
• Report Number: 2248146-2016-00031
• 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: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/03/2017
• Device Catalogue Number: 701056869
• Device Lot Number: 70101081
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2015
• 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