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

Model Number	I.V. STATION
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	08/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019 an iv bag that was prepared by an i.V.Station device had a label affixed that contained incorrect content.The label for a sodium phosphate preparation incorrectly included a bar code for vancomycin.The mislabeled preparation was identified and there are no known adverse patient effects.

• Brand Name: OMNICELL I.V.STATION
• Common Device Name: PHARMACY COMPOUNDING DEVICE
• Manufacturer (Section D): AEYSNT INCORPORATED; 51 pennwood place; warrendale PA 15086
• MDR Report Key: 8964981
• Report Number: 3011278888-2019-00089
• Device Sequence Number: 11393227
• Product Code: NEP
• UDI-Device Identifier: 08056477790007
• UDI-Public: (01)08056477790007(11)180911
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2019

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2019
• Initial Report FDA Received Date: 09/05/2019
• 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