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

Model Number	I.V. STATION
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: PHARMACY COMPOUNDING DEVICE
• Manufacturer (Section D): AESYNT INCORPORATED; 51 pennwood place; warrendale PA 15086
• MDR Report Key: 8901874
• Report Number: 3011278888-2019-00088
• Device Sequence Number: 10819799
• Product Code: NEP
• UDI-Device Identifier: 08056477790007
• UDI-Public: (01)08056477790007(11)190118
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2019

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
• Operator of Device: Health Professional
• Device Model Number: I.V. STATION
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other