MAUDE Adverse Event Report: DATASCOPE CORP CUSTOMER PERFUSION PACK; CARDIOPULMONARY

Catalog Number 701052579

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 09/30/2014

Event Type  malfunction  

Event Description

The customer is questioning the pack's sterility.

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: CUSTOMER PERFUSION PACK
• Type of Device: CARDIOPULMONARY
• Manufacturer (Section D): DATASCOPE CORP; fairfield NJ
• Manufacturer Contact: tina evancho ; 45 barbour pond dr; wayne, NJ 07470 ; 9737097256
• MDR Report Key: 4320453
• MDR Text Key: 5132311
• Report Number: 2248146-2014-00441
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/07/2014

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 Expiration Date: 05/31/2016
• Device Catalogue Number: 701052579
• Device Lot Number: 17310-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1