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

Model Number I.V.STATION

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 06/08/2016

Event Type  Injury  

Manufacturer Narrative

The manufacturer's investigation determined the action performed by the pharmacy technician can be described as a user error.The device was operating according to its specifications when the pharmacy technician introduced her arm inside the capper door to rotate a vial that was located on the vial cradle, hoping to accelerate the process of turning the vial.According to the device logs and the pharmacy technician's description of the events, the manufacturer understands the sequence of events as follows: the vial was placed by the robot arm in the vial cradle for recognition; the vial needed to be turned by the device in order for the label to be recognized; before the robot arm started the rotation of the vial, the pharmacy technician introduced her arm into the device with the objective of rotating the vial and accelerating the process; the robot arm continued the process of turning the vial, but encountered the pharmacy technician's hand and clipped it causing an injury; and the device emergency stop was activated and the device stopped.The pharmacy technician acknowledged that the action she performed was wrong.

Event Description

A pharmacy technician suffered a minor laceration to her left hand after introducing her arm into the operating device in an attempt to turn a vial inside of the device while it was running.The pharmacy technician was treated with stitches, released and resumed work the same afternoon.

• 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 34100 ; IT 34100
• 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: 5797661
• MDR Text Key: 49628204
• Report Number: 3006153342-2016-00001
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: I.V.STATION
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention