EDWARDS LIFESCIENCES DR VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM WITH ARM MOUNT RESERVOIR; KIT, SAMPLING, ARTERIAL BLOOD
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Model Number 48VMP160 |
Device Problems
Disconnection (1171); Detachment of Device or Device Component (2907)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The facility was not certain of the exact model or lot number but provided what was currently stocked on their shelves.The device evaluation is anticipated.However the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.In this event, there was no patient compromise 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 part of this monthly review.
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Event Description
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It was reported that the disposable pressure transducer/vamp system disconnected from the patient at the vamp reservoir while the patient was sitting in a chair.The rn quickly reacted to the alarm on the monitor and clamped the t-connector coming off of the arterial line.No patient complications were reported.
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Manufacturer Narrative
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One vamp adult system was returned for examination.The reported event of "vamp was disconnected" was confirmed.The tubing detached from the bond joint with a vamp adult reservoir stopcock.The tubing was bent near the point of detachment.Indications of bonding solvent were evident on tubing bond surface area.The tubing outer diameter was measured near the point of detachment and was found to be out of specification.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.A review of the manufacturing records indicated that the product met specifications upon release.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.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.In this event, there was no patient compromise 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 part of this monthly review.
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Manufacturer Narrative
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The investigation of this pressure monitoring kit with vamp adult concluded that a potential root cause could be related to an incorrect solvent bonding execution during the assembly process.Personnel acknowledgement was conducted at the manufacturing site to prevent recurrence of this type of complaint.
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Manufacturer Narrative
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Corrected data: f10, h6.Reference capa-20-00141.
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Search Alerts/Recalls
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