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

Model Number	I.V. STATION ONCO
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019 an i.V.Station onco device mislabeled a bag preparation.The label contained illegible content regarding both patient and drug information.The label was identified and there are no known adverse patient effects.

• Brand Name: OMNICELL I.V.STATION ONCO
• Common Device Name: PHARMACY COMPOUNDING DEVICE
• Manufacturer (Section D): AESYNT INCORPORATED; 51 pennwood place; warrendale PA 15086
• MDR Report Key: 8615500
• Report Number: 3011278888-2019-00058
• Device Sequence Number: 13998404
• Product Code: NEP
• UDI-Device Identifier: 08056477790014
• UDI-Public: (01)08056477790014(11)170828
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: I.V. STATION ONCO
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other