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

Model Number BEQ-T 4961

Device Problems Nonstandard Device (1420); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2014

Event Type  malfunction  

Event Description

Chief of perfusion at the facility stated that the plegiox in his custom plegia set is not cooling below 12c.The plegiox unit used in this kit was reported as being from lot # 70092153.No pt injury or death was associated with this failure.

Manufacturer Narrative

The component was returned by the facility and forwarded to the mfr for evaluation on (b)(4) 2014.A follow-up report will be submitted when the investigation is complete.Maquet has submitted an 806 notification for this component under #8010762-1/31/2014-001c.A "z" number has 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 de sousa ; 15 law dr.; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 3784922
• MDR Text Key: 4438561
• Report Number: 2248146-2014-00004
• 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: 01/08/2014

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 Expiration Date: 11/05/2013
• Device Model Number: BEQ-T 4961
• Device Catalogue Number: 701066914
• Device Lot Number: 16153-07
• Other Device ID Number: 70092153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2014
• Initial Date FDA Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2015
• 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