MAUDE Adverse Event Report: DATASCOPE FAIRFIELD ECLS CUSTOM PACK BO-TOP 20705; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 701053486

Device Problems Break (1069); Detachment Of Device Component (1104); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2018

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.(b)(4).

Event Description

It was reported that upon opening of an ecls custom pack bo-top 20705 the product had a cracked inlet connector on oxygenator and a broken off priming pigtail.This was found prior to use on the patient and therefore no patient injury.

Manufacturer Narrative

Correction: serial number changed from: unknown to: n/a as this device does not have a serial #.Device evaluation: the product was returned for evaluation.The tray and packaging were not returned for review.A visual inspection was performed confirming the broken port of quadrox-id adult.The evaluation confirmed the reported event.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 upon opening of an ecls custom pack bo-top 20705 the product had a cracked inlet connector on oxygenator and a broken off priming pigtail.This was found prior to use on the patient and therefore no patient injury.

• Brand Name: ECLS CUSTOM PACK BO-TOP 20705
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 7402093
• MDR Text Key: 104807515
• Report Number: 2248146-2018-00237
• 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: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2019
• Device Catalogue Number: 701053486
• Device Lot Number: 3000061302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Date Manufacturer Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1