MAUDE Adverse Event Report: AESYNT INCORPORATED OMNICELL I.V.STATION; PHARMACY COMPOUNDING DEVICE

Model Number I.V. STATION

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 11/19/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018 a report was received from an omnicell employee stating that an i.V.Station had not shaken cefazolin vials because a specific brand of the drug had been incorrectly configured on the device.This drug was used to produce 40 iv bags of csps (compounded sterile preparations).These 40 csps were not shaken and therefore may result in an incorrect dose or particulate in a preparation.The customer was notified of the issue and the drug was turned off in the device.There are no known adverse patient effects at this time.

• Brand Name: OMNICELL I.V.STATION
• Type of Device: PHARMACY COMPOUNDING DEVICE
• Manufacturer (Section D): AESYNT 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: 8194886
• MDR Text Key: 131934556
• Report Number: 3011278888-2018-00001
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 00861441000307
• UDI-Public: (01)00861441000307(11)170306
• 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,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2017
• 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