MAUDE Adverse Event Report: DATASCOPE CORP., CUSTOM TUBING PACK; CARDIOPULMONARY

Lot Number 17426-08

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2014

Event Type  malfunction  

Event Description

Pack had multiple caps missing and recirc/cpg tubing was severly kinked.

Manufacturer Narrative

The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.(b)(4).

• Brand Name: CUSTOM TUBING PACK
• Type of Device: CARDIOPULMONARY
• Manufacturer (Section D): DATASCOPE CORP.,; fairfield NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR, LLC; 45 barbour pond dr; wayne NJ 07470
• Manufacturer Contact: tina evancho ; 45 barbour pond dr; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4350901
• MDR Text Key: 18540268
• Report Number: 2248146-2014-00463
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 17426-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2014
• 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