Model Number PXMK2041 |
Device Problems
Contamination (1120); Material Discolored (1170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/09/2022 |
Event Type
malfunction
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Event Description
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As reported, when preparing these two pressure monitoring sets (medwatch ref (b)(4)) before surgery, the transparent saline solution used to flush the devices turned pink.Another pair of sets were used instead.Both sets were from the same box.The same issue did not occur with other sets taken from another box having the same lot.As per hospital process the pressure monitoring sets for the whole or are prepared together to be used on the same day so although a specific patient was not involved the user planned to use these sets on a patient or patients eventually.The devices are available for evaluation.
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Manufacturer Narrative
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One pressure monitoring set was received by our product evaluation laboratory for a full examination; however, the device evaluation has not yet been completed.Upon completion of the product evaluation a supplemental report will be sent with the investigation results.
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Manufacturer Narrative
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One pressure monitoring set was received by our product evaluation laboratory for a full examination.The report "the transparent saline solution used to flush the device turned pink" was unable to be confirmed.As received, there was liquid inside the entire length of the pressure line (coiled and distal lines).Liquid was flushed out and appeared to be transparent in color.However, the red striped pressure tubing from dpt housing to stand-alone stopcock (coiled line) was found tinged in pink.The red striped pressure tubing from stand-alone stopcock to the end of the pressure line (distal line) was not tinged in pink and appeared transparent as usual.Coiled pressure line remained pink after the liquid inside was flushed out.Coiled pressure tubing was flushed with lab saline and remained pink.Flushed out lab saline appeared transparent in color.Distal pressure tubing was also flushed with lab saline and no changes in color were noted in the tubing nor in the flushed out liquid.No visible damage or defect was observed from returned kit.The manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.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 was identified that this issue supplier related.Therefore, the supplier has been notified in order to perform an investigation to avoid the recurrence of this issue.Additionally, there are manufacturing controls to avoid potential causes related to the reported malfunction.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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