MAUDE Adverse Event Report: OMNICELL, INC. OMNICELL I.V.STATION ONCO; PHARMACY COMPOUNDING DEVICE

Model Number I.V. STATION

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 01/13/2020

Event Type  malfunction  

Event Description

On (b)(6) 2020 an i.V.Station mislabeled a syringe preparation.A failure to appropriately feed the label resulted in an unlabeled syringe (the intended drug preparation) and a mislabeled syringe when the incompletely fed label was unintentionally applied to the following syringe.Both the unlabeled and mislabeled preparations were identified and discarded.An adjustment was made to the printer label exit parameter to prevent recurrence.There is no adverse patient effect related to this event.

Manufacturer Narrative

As of (b)(6) 2020, the establishment registration and listing for this device was updated to omnicell, inc.From aesynt, inc, which was not reflected in the original report submission.Therefore, this report is a correction to the manufacturer listed in section d3.

• Brand Name: OMNICELL I.V.STATION ONCO
• Type of Device: PHARMACY COMPOUNDING DEVICE
• Manufacturer (Section D): OMNICELL, INC.; 51 pennwood place; warrendale PA 16066
• MDR Report Key: 9616930
• MDR Text Key: 190361135
• Report Number: 3011278888-2020-00002
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

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
• Device Operator: Health Professional
• Device Model Number: I.V. STATION
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 01/22/2020
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other