MAUDE Adverse Event Report: HEALTH ROBOTICS S.R.L. OMNICELL® I.V.STATION ONCO; PHARMACY COMPOUNDING ROBOT

Model Number ONCO

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2018

Event Type  malfunction  

Event Description

After a preparation of a 500ml bag was finished (prep id (b)(4)), the operator proceeded to unload it.She complained because she ended up with two different bags with the same label, one punctured 500ml bag and one non-punctured 100ml bag both with the label of the 500ml bag.An analysis of the logs showed that a 100ml bag was never loaded, therefore, since the operator unloaded a 100ml bag, the conclusion is that there was a user error in loading the bag.It was concluded that the operator, while unloading the 500ml bag, which was correctly labeled, loaded a 100ml bag incorrectly.At that point, the device could not have known that the 500ml bag had been unloaded.When the bag in that position was requested to be unloaded, the bag inside the device, at that point, was a 100ml bag.Upon unloading, it was labeled as if it were the 500ml bag.The operator did not follow the correct loading process causing the event described above.

• Brand Name: OMNICELL® I.V.STATION ONCO
• Type of Device: PHARMACY COMPOUNDING ROBOT
• Manufacturer (Section D): HEALTH ROBOTICS S.R.L.; piazzale legnami 1/b edificio9; trieste, trieste 34145 ; IT 34145
• Manufacturer (Section G): HEALTH ROBOTICS S.R.L. SLOVENSKA PRODRUZNICA; health robotics s.r.l.; kraska ulica 2; sezana, sezana 6210 ; SI 6210
• Manufacturer Contact: raffaella tolusso ; piazzale legnami 1/b edificio9; trieste, trieste 34145 ; IT 34145
• MDR Report Key: 7364893
• MDR Text Key: 103569562
• Report Number: 3006153342-2018-00001
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ONCO
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1