MAUDE Adverse Event Report: DATASCOPE CORP. LIVER TX WITH VHK 31000; CARDIOPULMONARY DEVICE

Model Number BEQ-T 16403

Device Problem Malfunction (2409)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2014

Event Type  malfunction  

Event Description

During use in a non-anticoagulated patient, a clot was observed in the top chamber of the plegiox heat exchanger.Flow through the device was still possible.No adverse events were reported.

Manufacturer Narrative

The device was returned to the manufacturer for evaluation.When the investigation is complete a supplemental report will be submitted.(b)(4).

• Brand Name: LIVER TX WITH VHK 31000
• 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: 3905450
• MDR Text Key: 20784905
• Report Number: 2248146-2014-00083
• 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: Physician
• Type of Report: Initial
• Report Date: 04/29/2014

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 Model Number: BEQ-T 16403
• Device Catalogue Number: 701065315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2014
• Initial Date FDA Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: No
• 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