MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOPLEGIA PACK 4:1; CARDIOPULMONARY DEVICE

Model Number BEQ-T 4961

Device Problem Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2014

Event Type  malfunction  

Event Description

Chief of perfusion at the facility reported that the plegiox in his custom plegia set is not cooling below 10c, so he cut out the plegiox and replaced it.It was noticed that the temperature port was not all the way down into the luer port so it was not coming into complete contact with the blood.No pt injury or death was reported in this case.

Manufacturer Narrative

The component was not returned for eval.If the product becomes available, an eval will be performed and a follow-up report submitted.Maquet has submitted an 806 notification for this component under #8010762-1/31/2014-001c.A "z" number had not yet been assigned.

• Brand Name: CARDIOPLEGIA PACK 4:1
• Type of Device: CARDIOPULMONARY DEVICE
• Manufacturer (Section D): DATASCOPE CORP.; fairfield NJ
• Manufacturer Contact: jason sousa ; 15 law dr.; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 3787366
• MDR Text Key: 19584594
• Report Number: 2248146-2014-00006
• Device Sequence Number: 1
• Product Code: DWF
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BEQ-T 4961
• Device Catalogue Number: 701066914
• Device Lot Number: ASKU
• Other Device ID Number: 70092153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 83 YR