MAUDE Adverse Event Report: OMNICELL, INC. OMNICELL I.V.STATION; 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 02/11/2020

Event Type  malfunction  

Event Description

On (b)(6) 2020 an i.V.Station device passed an underdosed syringe preparation.The syringe was mishandled after it was weighed and marked acceptable by the device due to improper functionality of the needle remover and robot pincers.The needle remover sensor and needle gripper pincers were replaced and calibrated to prevent recurrence of this issue.The underfilled preparation was identified and there are no known adverse patient effects.

Manufacturer Narrative

As of january 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.

• Brand Name: OMNICELL I.V.STATION
• Type of Device: PHARMACY COMPOUNDING DEVICE
• Manufacturer (Section D): OMNICELL, INC.; 51 pennwood place; warrendale PA 15086
• MDR Report Key: 9787295
• MDR Text Key: 190362252
• Report Number: 3011278888-2020-00008
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 08056477790007
• UDI-Public: (01)08056477790007(11)180227
• 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: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• 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
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other