MAUDE Adverse Event Report: DATASCOPE CORP. ECC QUADROX-ID 3/8; CARDIOPULMONARY DEVICE

Model Number BEQ-TOP 22600

Device Problem Malfunction (2409)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2014

Event Type  malfunction  

Event Description

It was reported that a patient was placed on the quadrox-id oxygenator and right away the perfusionist noted blood tinged fluid coming out of the gas outlet.Then it became frank blood.The oxygenator was changed and therapy continued with no reported injuries to patient.

Manufacturer Narrative

The device has not yet been returned for evaluation.When the device is returned an evaluation will be performed and a supplemental report will be submitted with the results of the investigation.(b)(4).

• Brand Name: ECC QUADROX-ID 3/8
• Type of Device: CARDIOPULMONARY DEVICE
• Manufacturer (Section D): DATASCOPE CORP.; fairfield NJ
• Manufacturer Contact: jason de sousa ; 15 law dr.; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 3987611
• MDR Text Key: 16556994
• Report Number: 2248146-2014-00090
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2016
• Device Model Number: BEQ-TOP 22600
• Device Catalogue Number: 701049440
• Device Lot Number: 16742-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 86