MAUDE Adverse Event Report: AESYNT 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	11/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019 an i.V.Station produced drug preparations with labels that contained incorrect content.Two labels were produced for each preparation.One label contained the correct content and indicated succinylcholine drug; a second label contained incorrect content mislabeling the preparation as rocuronium.The incorrect barcode was due to an error in the label configuration, which was fixed.The mislabeled preparations were identified and as such there is no known adverse patient effect.

• Brand Name: OMNICELL I.V.STATION
• Common Device Name: PHARMACY COMPOUNDING DEVICE
• Manufacturer (Section D): AESYNT INCORPORATED; 51 pennwood place; warrendale PA 15086
• MDR Report Key: 9415981
• Report Number: 3011278888-2019-00103
• Device Sequence Number: 533653
• Product Code: NEP
• UDI-Device Identifier: 08056477790007
• UDI-Public: (01)08056477790007(11)180227
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 12/05/2019

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: 11/11/2019
• Initial Report FDA Received Date: 12/05/2019
• 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