• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE, CATHETER TIP Back to Search Results
Model Number PX260
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 09/06/2018
Event Type  malfunction  
Manufacturer Narrative
The device evaluation is anticipated.However the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.A review of the manufacturing records indicated that the product met specifications upon release.
 
Event Description
While using a disposable pressure transducer (dpt), the diastolic blood pressure (dbp), systolic blood pressure (sbp) and mean arterial pressure (map) were observed to be lower than expected.It was indicated that there was no alarm or error message displayed.The user did not remember the displayed value.The issue was solved by using another transducer.The patient was not monitored with any other devices and no treatment was given.There was no allegation of patient injury.
 
Manufacturer Narrative
The reported event of issue with pressure reading was not confirmed.The dpt zeroed and sensed pressure accurately on a pressure monitor.Pressure readings were stable during 8 hours of an output drift test.Electrical testing showed that both input and output impedances were within specifications.Zero-offset also met specification.No leakage or occlusion was detected from the dpt kit during a pressure test.In addition, no visible damage was observed from the dpt kit.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.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 unknown if user or procedural factors contributed to the stated event.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 part of this monthly review.
 
Manufacturer Narrative
Corrected data: f10, h6.Reference capa-20-00141.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7910176
MDR Text Key122163327
Report Number2015691-2018-03930
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,Followup
Report Date 09/06/2018
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 Expiration Date12/06/2019
Device Model NumberPX260
Device Catalogue NumberPX260
Device Lot Number61179880
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2018
Initial Date Manufacturer Received 09/06/2018
Initial Date FDA Received09/26/2018
Supplement Dates Manufacturer Received10/17/2018
07/23/2020
Supplement Dates FDA Received10/30/2018
01/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-