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 08/10/2019

Event Type  malfunction  

Event Description

On (b)(6) 2019 an iv bag that was prepared by an i.V.Station device had a label affixed that contained incorrect content.The label for a sodium phosphate preparation incorrectly included a bar code for vancomycin.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: 8964981
• MDR Text Key: 158635647
• Report Number: 3011278888-2019-00089
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 08056477790007
• UDI-Public: (01)08056477790007(11)180911
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• 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: 08/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2018
• 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