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

Model Number 17310-06

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 09/02/2014

Event Type  malfunction  

Event Description

The customer is questioning the pack's sterility.They were not able to clarify if this pack had been palletized or not.

Manufacturer Narrative

Since the device is not available to be returned to us, a technical eval cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not by trends develop.(b)(4).

• Brand Name: CUSTOM 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: 4138723
• MDR Text Key: 4798186
• Report Number: 2248146-2014-00412
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2014

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: 07/01/2016
• Device Model Number: 17310-06
• Device Catalogue Number: 701052579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2014
• Initial Date FDA Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1