Model Number PXMKP11359 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/30/2024 |
Event Type
malfunction
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Event Description
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It was reported that there was contamination identified inside the iv tubing of the pressure monitoring kit.This was prior to use.There was a white particulate like material found inside the iv tubing above the roller clamp.There was no patient involvement.
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Manufacturer Narrative
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The device has been received and will be evaluated and the results are pending.Once the results are available, a supplemental submission will be sent.The device history record review is pending.The results will be sent when the results are available.
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Manufacturer Narrative
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The device was received for product evaluation.The evaluation findings confirmed the reported issue.One white particulate was observed in the flow path of the iv tubing at approximately 24cm from the spike.The particulate was approximately 1 mm x 0.5 mm in size.The whole line was flushed continuously for five minutes and the particulate moved to approximately 94 cm from the spike.However, it stayed inside the iv set.There was no other inconsistency observed.Further in depth analysis through the third party supplier found the white particulate material to be consistent with that of latex.After a thorough review, the third party supplier manufacturing processes and associated items are well controlled and devoid of latex.The tubing and components in question are supplied by edwards.As there was a presence of visible solution in the iv set, it is probable that the latex contamination originated from other operations beyond the third partys control.Regardless, the relevant operators will be trained to enhance their awareness and caution regarding this issue.The device history record review was completed and all manufacturing inspections passed with no non conformances.An engineering evaluation has been initiated to assess for any manufacturing related processes within edwards which could be correlated to the complaint.
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Manufacturer Narrative
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As the iv tubing is directly purchased from a third party supplier and the assembly of the iv set is completed by the third party supplier, the engineering evaluation has been completed by the third party supplier.It was concluded that the contamination inside the product was not related to the third party process.The third party manufacturing processes and associated items are well controlled and devoid of latex.It is probably the latex contamination originated from other operations beyond the third party control.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 the monthly review.
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Search Alerts/Recalls
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