MAUDE Adverse Event Report: AESYNT INCORPORATED OMNICELL I.V.STATION ONCO; PHARMACY COMPOUNDING DEVICE

Model Number I.V. STATION ONCO

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)

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

Event Date 10/15/2019

Event Type  malfunction  

Event Description

On (b)(6) 2019 a spill involving a chemotherapy drug preparation occurred inside the i.V.Station onco device.The spill was identified and subsequently cleaned by the user.There is no adverse patient effect related to this drug spill within the device, however, there is a concern regarding user exposure during clean-up of the spill.

Event Description

The event was originally filed under 3011278888-2019-00097 as follows: on (b)(6) 2019 a spill involving a chemotherapy drug preparation occurred inside the i.V.Station onco device.The spill was identified and subsequently cleaned by the user.There is no adverse patient effect related to this drug spill within the device, however, there is a concern regarding user exposure during clean-up of the spill.The cause of the spill was not yet determined at the time of submission.Since then new information has determined that the spill was due solely to the use of non-configured consumables on the i.V.Station onco.Syringes from a different manufacturer that had not been configured or approved for use on the i.V.Station onco device were being loaded for the drug preparation process.These syringes exhibited different dimensions from the validated syringes.As a result, the syringe needle was not always able to puncture the second membrane of the i.V.Bag.Subsequently, the bag port would fail due to an overpressure of the port causing drug to spill into the device.Event problem and evaluation codes have been updated to reflect this new information.

• Brand Name: OMNICELL I.V.STATION ONCO
• Type of Device: PHARMACY COMPOUNDING DEVICE
• Manufacturer (Section D): AESYNT INCORPORATED; 51 pennwood place; warrendale PA 15086
• Manufacturer (Section G): HEALTH ROBOTICS; kraska ulica, 4; sezana, 6210 ; SI 6210
• Manufacturer Contact: david vanella ; 500 cranberry woods drive; suite 400; cranberry township, PA 16066 ; 7247418115
• MDR Report Key: 9284755
• MDR Text Key: 170486324
• Report Number: 3011278888-2019-00097
• 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,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I.V. STATION ONCO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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
• Patient Outcome(s): Other