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

Model Number I.V. STATION

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 07/18/2019

Event Type  malfunction  

Event Description

On july 18, 2019 an i.V.Station device passed multiple underdosed and inadequately reconstituted vials used for final drug preparation.Sandoz vials used for cefazolin preparations were not effectively weighed during preparation, causing vials to be underfilled with diluent, not fully reconstituted after shaking and outside of the allowed percentage of error for vial preparation.All vials were identified and there are no known adverse patient effects.

• 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: 8901874
• MDR Text Key: 159198528
• Report Number: 3011278888-2019-00088
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 08056477790007
• UDI-Public: (01)08056477790007(11)190118
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• 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: 07/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2017
• 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