The international customer reported that the arterial lines of the radial artery pressure monitoring set were dampened and unable to draw blood after being inserted/rewired.The lines were reportedly in place for less than 48 hours, and the accuracy of the lines was limited.The circumstances surrounding the usage and handling of the devices leading up to the reported clotting were not reported.Additional information has been requested from the customer.The product is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
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Additional information: pma/510(k) #: preamendment.Investigation - evaluation: a review of the quality control and specifications was conducted during the investigation.Clinical assessment: it is not certain if ¿overdamping¿ or ¿underdamping¿ is occurring.In either case, the accuracy of the systolic and diastolic pressures would be inaccurate.Often, overdamping is more associated with loose connections, air bubbles, kinks, blood clots, arterial spasms or narrow tubing which would be more consistent with the inability to draw blood from the line.In overdamping, there is a sluggish resonance in the system resulting in an underestimated systolic pressure or overestimated diastolic pressure.The c-pms-300-ra contains the p3.0-18-5-w-ns-0 central venous catheter.There is no information regarding the placement of the device or any difficulty with placement that may have contributed to this event.There is no mention of leaking that may have contributed to this event.There is no information regarding securing the device or any environmental issues that may have contributed to this event.There is no information regarding any human anatomy or physiology that may have contributed to this event.At this time, clinical assessment cannot eliminate any possible causes for this event such as placement, user technique, product handling, environmental, maintenance, device failure, or manufacturing related causes.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The lot number of the device is not known; accordingly, a review of the device history record and complaint lot search could not be conducted.A definitive root cause could not be determined, however; based on the provided information the likely root cause is deemed to be; ¿inconclusive¿.We will continue to monitor similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.
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