MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PX260

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Code Available (3191)

Event Date 03/26/2015

Event Type  malfunction  

Event Description

As reported, while using a disposable pressure transducer (dpt) on the patient, there was an erroneous pressure displayed on the monitor.Further information revealed that all the air was removed from the bag and all lines before use, the solution bag was pressurized at 300 mmhg, and the transducer was leveled at heart (atrium) level.The measured value with the hand cuff was 180 mmhg, while the expected value was 140 mmhg and the real value measured was 70 mmhg.There was an alert on the monitor when the monitor displayed 70 mmhg.However, the patient was treated unnecessarily and had high blood pressure.Trouble-shooting was performed.The dpt was changed and the monitor displayed 180 mmhg measurement.The vented caps were replaced by the non-vented caps and the monitor was adjusted to read zero mmhg.No other details were provided.

Manufacturer Narrative

Unnecessary patient treatment for high blood pressure evaluation summary: customer report of erroneous values was not confirmed.The dpt zeroed and sensed pressure accurately on a pressure monitor.No error message was noted on the monitor.Pressure did not show any drift during output drift testing and the device met all specifications.No leakage or occlusion was detected from the dpt kit during pressure testing.No visible defect was observed from the dpt kit.Additional manufacturer narrative: the dpt instructions for use (ifu) provide the following information and guidance related to abnormal pressure readings: pressure readings can change quickly and dramatically because of loss of proper calibration, loose connection, or air in the system.Warning: abnormal pressure readings should correlate with the patient¿s clinical manifestations.Verify transducer function with a known amount of pressure before instituting therapy.Caution: significant distortion of the pressure waveform or air emboli can result from air bubbles in the setup.Note: poor dynamic response can be caused by air bubbles, clotting, excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.It could not be determined if any clinical factors may have contributed to the event with the available information.No issues were found with the subject device.No further actions will be taken at this time.

• Brand Name: PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: lynn selawski ; 1 edwards way; ms: jamb b 2; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4737922
• MDR Text Key: 5824296
• Report Number: 2015691-2015-00971
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/31/2015

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: PX260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 04/29/2015
• 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