MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CUSTOMER DEFINED PRESSURE MONITORING KIT; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number T001691M

Device Problem Cut In Material (2454)

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

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However the complaint could not be confirmed without the completion of the product evaluation.A supplemental report will be forthcoming with the evaluation results.The 510k number is unknown as the model number is a custom defined product.

Event Description

As reported, when opening the package of the dpt (disposable pressure transducer) with the lass valve, it was noticed that the pressure line was cut next to the tubing connector.Another kit was used and worked successfully.There was no allegation of patient injury.The product is available for evaluation.

Manufacturer Narrative

We received one single dpt - vamp plus kit for examination.No priming solution was visible inside of the kit.The pressure tubing was found broken from the female connector that was connected to the dpt zero-stopcock.The tubing was bent near the point of damage.Cross surfaces of the broken tubing appeared uneven and rough.Bonding solvent filled up the gap between the tubing and female connector at the bond area.No other damage was observed from the kit.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.A review of the manufacturing records indicated that the product met specifications upon release.

• Brand Name: CUSTOMER DEFINED PRESSURE MONITORING KIT
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 5513444
• MDR Text Key: 41162461
• Report Number: 2015691-2016-00861
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2017
• Device Model Number: T001691M
• Device Lot Number: 60074598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2015
• 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