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

Model Number BO-TOP 27300

Device Problem Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported that the tubing in custom pack kinked.They had to work kinks/memory bends out of tubing prior to use.Tubing is placed on a connector and twisted before attachment to another connector and can be seen in the red striped tubing, the stripe twists.

Manufacturer Narrative

A capa was opened to address the occurrence of this event.(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: 4804467
• MDR Text Key: 15132797
• Report Number: 2248146-2015-00048
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/28/2015

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 Model Number: BO-TOP 27300
• Device Lot Number: 3000007545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/27/2015
• 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