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	03/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019 an i.V.Station device mislabeled a bag preparation.The label intended for a heparin preparation contained the corrent heparin information, but also contained some information for a separate vancomycin preparation.The label containing duplicative and incorrect content was identified and discarded, and as such there is no adverse patient effect.However, if the malfunction causing incorrect content to print on a label were to recur, there are potential circumstances that would result in the incorrect preparation being used, potentially causing serious injury and/or death.

• 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: 8555708
• Report Number: 3011278888-2019-00050
• Device Sequence Number: 2168696
• Product Code: NEP
• UDI-Device Identifier: 08056477790007
• UDI-Public: (01)08056477790007(11)170728
• 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): 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 03/27/2019
• Initial Report FDA Received Date: 04/26/2019
• 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