Model Number I.V.STATION ONCO |
Device Problems
Computer Software Problem (1112); Nonstandard Device (1420); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/08/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The i.V.Station onco risk analysis was reviewed for the potential hazardous situation where a mislabeled bag is unloaded by the operator.Based on the information received and confirmed from the site, clinical input, and in accordance to our risk management process the risk associated with the probability of a hazardous situation leading to a harm (mislabeled bag administered to a patient) is not acceptable therefore health robotics has initiated a medical device field correction to advise all affected customers of the potential issue and immediate corrective mitigations.
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Event Description
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During routine use of an i.V.Station onco, an error occurred in the motor of the bags carousel and a mislabeled bag was unloaded by the pharmacy technician.The mislabeled bag was detected and was not delivered to a patient.There was no patient injury as a result of this event.The i.V.Station onco was quarantined until an investigation was completed.In particular, an error occurred in the motor of the bags carousel while the pharmacy technician was unloading the bag preparations on the i.V.Station onco.The error led to a bag to be unloaded by the pharmacy technician with the wrong label.The field service engineer that was onsite intervened when not all bags were unloaded and noticed there was an error with the last bag unloaded and immediately notified the pharmacist onsite.The bag was weighted and it was confirmed it had been mislabeled.The iv bag was not transferred to a patient and was subsequently destroyed.The i.V.Station onco device has been quarantined until an investigation is completed.There was no patient injury as a result of this event.
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Search Alerts/Recalls
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