MAUDE Adverse Event Report: DATASCOPE CUSTOM TUBING PACK ; CARDIOPULMONARY

Model Number BEQ-TOP 4709

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2015

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluations are completed.(b)(4).

Event Description

Kit was opened and primed with saline.Outside of "red lined" arterial tubing was found to have a sticky yellow substance on it.So they opened another and primed it.

Manufacturer Narrative

After examining the kit that was returned it was determined that the residue can be contributed to using etc tape to connect the 3/16" line for the tray spacer and the line being pulled during setup.Corrective actions have been taken.We are unable to determine when this may have occurred.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.

• Brand Name: CUSTOM TUBING PACK
• Type of Device: CARDIOPULMONARY
• Manufacturer (Section D): DATASCOPE; fairfield NJ
• Manufacturer Contact: tina evancho ; 45 barbour pond drive ; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4996183
• MDR Text Key: 22890434
• Report Number: 2248146-2015-00070
• Device Sequence Number: 1
• Product Code: DWE
• 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: company representative,health
• Reporter Occupation: Not Applicable
• Type of Report: Followup
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2016
• Device Model Number: BEQ-TOP 4709
• Device Lot Number: 3000003212
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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