MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD BEQ-TOP 9004 1/4 CUSTOM PK W/RF32 & HMOD; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 701054451R01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Unspecified Infection (1930)

Event Date 04/12/2019

Event Type  Death  

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).

Event Description

It was reported that a patient was placed on extracorporeal membrane oxygenation (ecmo )with a beq-top 9004# ecc-pack circuit.One week later the patient had positive wound cultures for candida parapsilosis.Subsequently, the patient had multiple positive cultures from multiple sources.The ecmo coordinator indicated that given the patient¿s medical history, positive cultures were not surprising.They were unable to confirm the source of the exposure.The circuit was in use for approximately one month.It was later reported that the patient has expired.There was no reported malfunction o the device.

• Brand Name: BEQ-TOP 9004 1/4 CUSTOM PK W/RF32 & HMOD
• 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: 8675838
• MDR Text Key: 147234744
• Report Number: 2248146-2019-00459
• 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: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: 701054451R01
• Device Lot Number: 3000083489
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1650-2019
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 12 MO