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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CLEARSIGHT PRESSURE CONTROLLER KIT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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EDWARDS LIFESCIENCES CLEARSIGHT PRESSURE CONTROLLER KIT SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number PC2K
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Patient Involvement (2645)
Event Date 06/22/2017
Event Type  malfunction  
Manufacturer Narrative
Evaluation of the returned device confirmed the observance of inaccurate values. The measured results were out of tolerance; "too high," and all values exceeded the specifications for finger cuff #1 and #2. No physical damage was detected during the visual examination. A definitive root cause for the failure was unable to be determined. If additional information is obtained, a supplemental report will be submitted. With any hemodynamic monitoring, pressure readings can change quickly and dramatically. Pressure readings should correlate with the patient¿s clinical manifestations. These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use. 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.
 
Manufacturer Narrative
The referenced device reported originated as the result of a system-related complaint for an ev1000ni system. During an evaluation performed at an edwards regional service center, while assessing the system-related pump, the pressure controller allegedly provided blood pressures out of range. The evaluation performed at the service center tested 3 different pressure points: 100, 200, and 300 mmhg. The test values exceeded the upper limits of 102, 202. 20, and 302. 20 mmhg. However, these test pressure points and their associated tolerances are not reflective of real-world values or tolerances that would alter treatment decisions. The nominal pressure value expected for adults is 120/80; a deviation of 4 or 6 mmhg, which were observed at the 100 and 200 mmhg test points, would not be sufficient to change treatment decisions. Afterwards, the device was forwarded to the supplier to conduct further testing. The results of the supplier¿s evaluation did not confirm the issue. In addition, for both cuff connectors, the supplier¿s tester observed normal bp values well within the limits of the ft3 tester. The nominal values of 120/80 were tested and found to be normal with no deviations. Based on the aforementioned notes, this complaint was determined to be unconfirmed, and no defect was found.
 
Manufacturer Narrative
Review of the device history record supports that there were no non-conformances or prior service for any reason. The device is expected to be evaluated; however, at the time of this report, the evaluation has not yet been completed. A supplemental report will be submitted to communicate the complaint investigation results.
 
Event Description
It was reported that during maintenance of an ev1000 pump unit, the pump was unable to be switched on. There was no patient involvement as this event occurred during service and testing. During evaluation of the entire ev1000 ni system, the observed values were not compliant with the testing protocol; the inaccurate values were detected and isolated to the pressure controller identified in this report. The inaccurate blood pressure values were: for 100 mmhg, the value should have registered between 98 and 102 mmhg, however it was 103. 08 for 200 mmhg, the value should have registered between 197. 80 to 202. 20 mmhg, however it was 204. 73 for 300 mmhg the value should have registered between 297. 80 to 302. 20 mmhg, however it was 305. 85 mmhg. No error messages were observed and no other system-related devices were identified as suspect.
 
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Brand NameCLEARSIGHT PRESSURE CONTROLLER KIT
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
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
irvine, CA 92614
9497564386
MDR Report Key6752150
MDR Text Key247555100
Report Number2015691-2017-02266
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K140312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Service and Testing Personnel
Device Expiration Date02/01/2021
Device Model NumberPC2K
Device Catalogue NumberPC2K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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