Model Number PXVJ050M |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 11/03/2021 |
Event Type
malfunction
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Event Description
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As reported, during use with patient of a disposable pressure transducer with vamp junior, the pressure tubing suddenly came away, resulting in patient bleeding into the bed (medwatch #09719).It is unknown how much blood leaked.Two new transducers were tried as replacement and the same issue occurred, although there was no blood loss at that time (medwatch #09785 and medwatch #09787).There were no complications or additional interventions needed.There was no allegation of patient injury.Patient demographics unable to be obtained.The product is expected to be returned for analysis; however, it has not yet been received.
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Manufacturer Narrative
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The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.
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Manufacturer Narrative
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One pressure monitoring set with vamp jr was received by our product evaluation laboratory for full examination.Customer report of tubing issue was confirmed.However, the pressure tubing was found completely broken from the proximal bond joint with vamp jr reservoir instead of being detached.Cross surfaces of broken tubing appeared rough and uneven.Broken mating tubing was visible at vamp jr reservoir bond joint.Residual adhesive visible on the broken tubing.Pressure tubing was found partially broken from the distal bond joint with vamp jr reservoir.Pressure tubing was found completely broken from the bond joint with male connector.Cross surfaces of broken tubing appeared rough and uneven.Broken mating tubing was visible at connector bond joint.Residual adhesive was visible on the broken tubing.No other visible damage was observed from returned kit.An engineering investigation has been initiated to consider any potential factors that may have contributed to this complaint.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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Based on further engineering investigation, it could be concluded that the type of fracture found indicates that plasticizer of the tubing material migrated to the surface causing the tubing fracture.Potential causes could be related to environment, time (tubing ageing), solvent (chemical reaction with tubing), tubing material and contact of the tubing with chemical agents.Pra was generated for this condition and edwards is initiating actions to further investigate the failure mode to eliminate the root cause(s) and to prevent recurrence of this type of complaint.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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Search Alerts/Recalls
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