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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 12/18/2020
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation as it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.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.It is not known if user or procedural factors may have contributed to the stated event.In this event, there was no patient compromise noted.
 
Event Description
It was reported that after few minutes of use in patient of this disposable pressure transducer (dpt), there was an unexplained drop of blood pressure measurements.The blood pressure was initially displayed correctly for 3 minutes.The value provided was 3 or 4 points below the expected value.The values were compared to a blood pressure cuff.The values coming from the cuff were good and as expected.Which were the same values given by this sensor at first of the measurement before the sudden drop.The measurements taken by the dpt sensors were those of arterial pressure while those taken by the blood pressure cuff corresponded to the blood pressure from the arm.There was no allegation of any error message or alert displayed.The patient was treated according to the values obtained from the blood pressure cuff.The issue solved after replacing this dpt by another one from a different lot number.There was no allegation of patient injury.The involved device was not available for evaluation, as it have not been retained by the service.Another dpt from the same lot number but with a different patient has been reported for the same issue.
 
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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 
Manufacturer (Section G)
EDWARDS LIFESCIENCES DR
parque industrial de itabo
carr. sanchez km 18.5
haina, san cristobal
DR  
Manufacturer Contact
samantha eveleigh
1 edwards way
irvine, CA 92614
9492503939
MDR Report Key11143262
MDR Text Key227068976
Report Number2015691-2021-00088
Device Sequence Number1
Product Code DXO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K925638
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/18/2020
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 Number63325659
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/18/2020
Initial Date FDA Received01/08/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age75
Patient Weight74
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