EDWARDS LIFESCIENCES CLEARSIGHT PRESSURE CONTROLER KIT; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
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Model Number PC2K |
Device Problems
Incorrect Measurement (1383); Decrease in Pressure (1490)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The pressure controller was returned a technical service center for testing and it failed; receiving a value of 260.10mmhg out of 300mmhg.The product is expected to be returned to the manufacturer for further analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.A device history record review was completed and documented that the device met all specifications upon distribution.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.
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Event Description
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As reported, during testing at a local service provider of this pressure controller, it was found that during the review test, the pressure in one channel did not stay at the level set on the tester level of 300mmhg.It decreased to the value of 268.51 mmhg.There was no allegation of patient injury.The pressure controller was returned a technical service center for testing and it failed; receiving a value of 260.10mmhg out of 300mmhg.
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Manufacturer Narrative
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The pressure controller was returned to the manufacturer for further evaluation.When it was connected to a known working system there were no errors.When a patient simulator was attached to cuff 2 and set to 120/80 the values returned were 130/80.When the same simulator was connected to cuff 1 it returned a reading of 121/81.When tested on the functional tester it failed several leak tests.Failed pressure cuff 2-1: at 233.1672 mmhg, (limits 300 to 350).Failed air leakage 1 at 32.4, (limits 0 to 12).Failed pressure cuff 2-2 at 241.5573 (limit 300 to 350).Failed air leakage 2 at 32.4, (limit 0 to 12).When a known working valve was installed on the cuff 2 side of the board, it passed all of the leak tests and calibration tests.It was then connected to the patient simulator and it gave a reading of 124/80.An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.These devices are typically used in intensive care units or operating rooms where patients are closely monitored.It is unknown whether any user or procedural factors contributed to this event.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.
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Manufacturer Narrative
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Corrected data: f10, h6.Reference capa-20-00141.
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