MAUDE Adverse Event Report: HEALTH ROBOTICS S.R.L. I.V.STATION; PHARMACY COMPOUNDING DEVICE

Model Number I.V.STATION ONCO

Device Problems Computer Software Problem (1112); Nonstandard Device (1420); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: I.V.STATION
• Type of Device: PHARMACY COMPOUNDING DEVICE
• Manufacturer (Section D): HEALTH ROBOTICS S.R.L.; via san francesco,22; trieste, trieste 34133 ; IT 34133
• Manufacturer (Section G): HEALTH ROBOTICS S.R.L. SLOVENSKA PODRUZNICA; kraska ulica 2; sezana, 6210 ; SI 6210
• Manufacturer Contact: raffaella tolusso ; via san francesco, 22; trieste, trieste 34100 ; IT 34100 ; 0403498456
• MDR Report Key: 6138402
• MDR Text Key: 61553127
• Report Number: 3006153342-2016-00002
• Device Sequence Number: 0
• Product Code: NEP
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: I.V.STATION ONCO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2015
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1