MAUDE Adverse Event Report: OMNICELL, INC. OMNICELL I.V. STATION; PHARMACY COMPOUNDING DEVICE

Model Number i.v.STATION

Device Problem Expiration Date Error (2528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

Upon evaluation of the device, it was determined that the device was on the incorrect version of software which caused the error.The device was updated to software version (b)(4) which resolved the issue; the bag label was updated with the correct beyond use date.No additional information is available at this time.

Event Description

It was reported that the device printed an incorrect beyond use date (bud) on the label during preparation.The customer prepared succinylcholine 200 mg/10 ml syringe that was labeled with label with an expiration date of 8/14; however but the vial used in creating the prep expires 8/1.No adverse events were reported as a result of this malfunction.

• Brand Name: OMNICELL I.V. STATION
• Type of Device: PHARMACY COMPOUNDING DEVICE
• Manufacturer (Section D): OMNICELL, INC.; 51 pennwood place; warrendale PA 15086
• Manufacturer (Section G): OMNICELL S.R.L; piazzale legnami 1/b edificio; 9 comprensorio gasilini; trieste, trieste 34145 ; IT 34145
• Manufacturer Contact: david vanella ; 500 cranberry woods drive; cranberry twp, PA 16066
• MDR Report Key: 12116461
• MDR Text Key: 263506504
• Report Number: 3011278888-2021-00009
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 08056477790007
• UDI-Public: (01)08056477790007(11)200207
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• 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: 06/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1