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

Catalog Number 701053486

Device Problem Circuit Failure (1089)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.We are unable to confirm the reported event.If additional information is provided we will send a supplemental report with our additional findings.(b)(4).

Event Description

It was reported that during extra corporeal life support (ecls) process, the bladder component in the custom ecls pack bo-top 20705 circuit leaked.The bladder component was removed from the circuit and was returned directly to the original equipment manufacturer by the facility.The facility reported there was no injury to the patient and they would not release any additional patient information.

• 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
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 7310903
• MDR Text Key: 101618079
• Report Number: 2248146-2018-00135
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2018
• Date Device Manufactured: 10/19/2017
• 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