MAUDE Adverse Event Report: AEYSNT INCORPORATED 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 03/26/2019

Event Type  malfunction  

Event 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
• Type of Device: PHARMACY COMPOUNDING DEVICE
• Manufacturer (Section D): AEYSNT INCORPORATED; 51 pennwood place; warrendale PA 15086
• Manufacturer (Section G): AESYNT INCORPORATED; 51 pennwood place; warrendale PA 15086
• Manufacturer Contact: david vanella ; 500 cranberry woods drive; suite 400; cranberry township, PA 16066 ; 7247418115
• MDR Report Key: 8555708
• MDR Text Key: 147322575
• Report Number: 3011278888-2019-00050
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 08056477790007
• UDI-Public: (01)08056477790007(11)170728
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• 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: 03/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other