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

Model Number BO-TOP 27300

Device Problem Misconnection (1399)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2014

Event Type  malfunction  

Event Description

Customer states since migrating to new reservoir, the venous line port cap falls off in packaging and cannot be put back in place.Blue cap on venous inlet port on top of venous reservoir was found to be off in package and or falls of easily.

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 any trends develop.(b)(4).

Manufacturer Narrative

Though the device was not returned for evaluation, a capa was opened to address the issues of caps falling off.Internal complaint number (b)(4).

• Brand Name: CUSTOM TUBING PACK
• Type of Device: CARDIOPULMONARY
• Manufacturer (Section D): DATASCOPE CORP.; fairfield NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR; 45 barbour pond dr; wayne NJ 07470
• Manufacturer Contact: tina evancho ; 45 barbour pond dr; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4502705
• MDR Text Key: 5445140
• Report Number: 2248146-2015-00002
• 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,Company Representative,company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BO-TOP 27300
• Device Lot Number: 17816-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2015
• 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