Model Number PXVP23X3AT3 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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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Event Description
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It was reported that viscous fluid was found in the reservoir of a truwave vamp during device set up.Hospital staff noticed that a ring in the syringe was left behind from the fluid when pushing the plunger up and back.No patient involvement.
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Manufacturer Narrative
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An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.An image was provided by the customer, which confirmed the reported event.A potential cause could be related to the siliconizing process.Silicone oil, polydimethylsiloxane pdms, is used in the manufacturing process of the vamp plus as a lubricant to the inside walls of the body and plunger or cap interface.During the siliconizing process, the operator is required to insert the plunger into the body and carefully rotate it in and out to distribute the silicone throughout the body.In addition, visual inspection is required to ensure that there is no excess of silicone is observed inside the syringe.Corrections to the h6 codes investigation findings and investigation conclusions were made.
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Manufacturer Narrative
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The device was not returned for evaluation.It was previously reported that the device was available for return, but it was discarded.An image evaluation was initiated for the customer provided photo.The photo showed a vamp plus reservoir.The reported event of ring of fluid inside the vamp reservoir was confirmed.A ring of what appeared to be clear material was visible inside the vamp plus reservoir.However, without the return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.No corrective actions will be taken at this time.A supplemental report for the device history record will be forthcoming when the investigation is completed.
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Search Alerts/Recalls
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