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 05/20/2019

Event Type  malfunction  

Event Description

On (b)(6) 2019 a preparation that was compounded by an i.V.Station device had a label affixed that contained incorrect content.The beyond use date (bud) printed on the label exceeded the expiration date provided by the vial manufacturer.Specifically, the drug vial indicated an expiration date of june 30, 2019, while the bud date printed on the compounded sterile preparation was august 18, 2019.The mislabeled preparation was identified and there are no known adverse patient effects.

• 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: 8653753
• MDR Text Key: 146494289
• Report Number: 3011278888-2019-00062
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 08056477790007
• UDI-Public: (01)08056477790007(11)180108
• 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: Other
• Type of Report: Initial
• Report Date: 05/30/2019

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
• Device Operator: Health Professional
• Device Model Number: I.V. STATION
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• 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