MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR DISPOSABLE PRESSURE TRANSDUCER

Model Number DPTUNKNOWN

Device Problem High Readings (2459)

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

Event Date 02/05/2014

Event Type  malfunction  

Manufacturer Narrative

One single dpt kit without any attached component was received for evaluation.The examination revealed that the dpt performed zeroing but it did not sense pressure accurately.The pressure readings were higher than actual applied pressure.The electrical testing showed that both the input and output impedances of the dpt were unstable.The solder joints area of the dpt sensor chip was found to be corroded with what appeared to be salt like material.An occlusion of the salt crystalized material was noted along the leak path.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.The reported event was confirmed.Further investigation is underway to replicate this event and to identify any potential manufacturing factors that may have contributed to this complaint.A supplemental report will follow.

Manufacturer Narrative

Upon further examination it was observed that there was a dark residue or corrosion on the resistors of the sensor opposite the cable solder joints.The dpt sensor in general was discolored with a dull appearance.In addition, there was no leakage that occurred during the pressure tests.It can be concluded that the corrosion is not the result of a compromised seal between the sensor and the plastic dpt housing.

Event Description

It was reported that the device was zeroed.Then there was a drift upwards of the arterial line reading which was initially treated with drug therapy.The transducer was changed out when it was noticed for the second time that the transducer arterial line drifted.The patient's condition was not compromised due to the drifting arterial line reading.

• Brand Name: DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: DISPOSABLE PRESSURE TRANSDUCER
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo; haina, san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 3651049
• MDR Text Key: 11736750
• Report Number: 2015691-2014-00457
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DPTUNKNOWN
• Device Lot Number: LOT UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2014
• 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