MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD CUSTOM TUBING PACK; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 701053361

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

Although the product was not returned for evaluation, a picture was provided.A review of the provided picture confirmed the quick connects were not inside the clamshell.The root cause of the quick connects being outside of the clamshell has been determined to be assembler error.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.(b)(4).

Event Description

It was reported that prior to use of the beq-t 8805 custom tubing pack it was noted that the quick-connects were incorrectly placed outside of the sterile protective clamshell.The pack was used by cutting the tubing inside the sterile pack.This was noted prior to patient use and therefore there was no patient involvement.

• Brand Name: CUSTOM TUBING PACK
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 8703383
• MDR Text Key: 148174018
• Report Number: 2248146-2019-00508
• 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: Other
• Type of Report: Initial
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2021
• Device Catalogue Number: 701053361
• Device Lot Number: 3000093554
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2019
• 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