One single dpt kit with vamp plus system was returned for examination.The reported event of ¿one of the connections broke¿ was confirmed.As received the pressure tubing was found detached from the solvent bond joint with a proximal sample site.Indications of what appears to be bonding solvent were evident on some locations of tubing bond surface area.The tubing outer diameter was measured near the point of detachment and was found to be within specification.No other visible damage or defect was observed from the kit.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.It is common clinical practice to inspect all products before usage.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.In addition, they are used in critical care units or ors where patients are closely monitored.If the pressure tubing becomes detached during use, it will affect the pressure waveform, which will immediately alert the clinician to begin the troubleshooting process.In this case, there were no patient complications noted.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 a part of the monthly review.
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