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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number PX260
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/24/2020
Event Type  malfunction  
Manufacturer Narrative
One single dpt kit was received for evaluation.The reported event of inaccurate values was confirmed.Dpt sensor did not zero nor sense pressure on ev1000 monitor.Error message "selected cvp zero point out of tolerance.Check dpt" was showed on ev1000 monitor.Electrical testing showed that both input impedance and output impedance of dpt sensor were within specifications.However, zero-offset value did not meet the specification.No visible damage or defect was observed from sensor chip, solder joints, cable and cable connector.Electrical testing and visual examination suggested the out of specification condition was within the sensor chip.Poor dynamic response can be caused by air bubbles, clotting, and excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.The assembly may be tested for dynamic response by observing the pressure waveform on an oscilloscope or monitor.Bedside determination of the dynamic response of the catheter, monitor, kit and transducer system is done after the system is flushed, attached to the patient, zeroed and calibrated.A square-wave test may be performed by pulling the snap tab device and releasing quickly.Pressure readings can change quickly and dramatically because of loss of proper calibration, loose connection, or air in the system.Pressure readings should correlate with the patient¿s clinical manifestations.In this event, there was no patient compromise noted.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
 
Event Description
It was reported that during use in patient of this disposable pressure transducer, the central venous pressure (cvp) displayed was not correct.The expected value according to the clinical patient status was between 0-12 mmhg.However the value showed persistently without any fluctuation was 40 mmhg.Additionally, cvp waveform was not displayed.There was no error message or alarm.Replacing the dpt for another one the issue was solved.There was no allegation of patient injury.The device was available for evaluation.Patient demographics are not available.
 
Manufacturer Narrative
It was initially reported that the cvp value was incorrect without a wave form present.In the case, of physiologic parameter displaying without a waveform present, the user would be prompted to troubleshoot, as a waveform should always be present with the cvp values.This serves as a correction and the complaint no longer meets the criteria as reportable.
 
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Brand Name
PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
Type of Device
TRANSDUCER, PRESSURE, CATHETER TIP
Manufacturer (Section D)
EDWARDS LIFESCIENCES DR
parque industrial de itabo
carr. sanchez km 18.5
haina, san cristobal
DR 
MDR Report Key11040922
MDR Text Key224412749
Report Number2015691-2020-15097
Device Sequence Number1
Product Code DXO
Combination Product (y/n)N
PMA/PMN Number
K925638
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/02/2020
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 NumberPX260
Device Catalogue NumberPX260
Device Lot Number63146873
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2020
Initial Date Manufacturer Received 12/02/2020
Initial Date FDA Received12/18/2020
Supplement Dates Manufacturer Received12/02/2020
Supplement Dates FDA Received12/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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