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

Catalog Number 709000078

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 01/11/2019

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.(b)(4).

Event Description

It was reported that during priming of the custom ecc specialty tube pack beq-top 50903 the arterial side luer port loaded with pigtail/stopcock at the apex of the quadroxid was broken when the specialty pack was opened for set-up.Customer reports that this occurred during delivery as the luer port pigtail was already found broken off when pack was initially opened.The quadroxid was replaced and the custom tube pack was used.This occurred prior to priming and therefore there was no patient involvement.

Manufacturer Narrative

Device lot number changed from: 3000073166 to: 3000063290.Expiration date changed from: 05/03/2020 to: 12/06/2019.Device manufacture date changed from: 05/03/2018 to: 12/06/2017.The associated tray and packaging was not returned and could not be reviewed for any damage.The oxygenator was returned for review for the broken port on the quadrox-id.The broken end of the port was still connected in the pigtail.This pigtail is connected to the port.There was also priming fluid present in the oxygenator.Based on the investigation, the most likely root cause of the broken oxygenator port can be attributed to rough handling during use / set up by the customer.At this time the complaint will be recorded in the complaint database for future reference.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint #(b)(4).Record id (b)(4).

Event Description

It was reported that during priming of the custom ecc specialty tube pack beq-top 50903 the arterial side luer port loaded with pigtail/stopcock at the apex of the quadroxid was broken when the specialty pack was opened for set-up.Customer reports that this occurred during delivery as the luer port pigtail was already found broken off when pack was initially opened.The quadroxid was replaced and the custom tube pack was used.This occurred prior to priming and therefore there was no patient involvement.

• Brand Name: CUSTOM ECC SPECIALTY TUBE PACK BEQ-TOP 50903
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8292269
• MDR Text Key: 136302743
• Report Number: 2248146-2019-00063
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K08059223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 3000073166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 04/29/2019
• Supplement Dates FDA Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1