FDA Adverse Event Malfunction Summary report: N

OMNICELL I.V. STATION ONCO

MDR report key: 11551547 · Received March 23, 2021

Report

Report Number: 3011278888-2021-00005
Event Type: Malfunction
Date Received: March 23, 2021
Date of Event: March 5, 2021
Report Date: May 26, 2021
Manufacturer: OMNICELL, INC.
Product Code: NEP
UDI-DI: 08056477790014
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

AS OF (B)(6) 2020, THE ESTABLISHMENT REGISTRATION AND LISTING FOR THE MANUFACTURER OF THIS DEVICE WAS UPDATED TO OMNICELL, INC. FROM AESYNT, INC, WHICH WAS NOT REFLECTED IN THE ORIGINAL REPORT SUBMISSION. ADDITIONALLY, AS OF (B)(6) 2021, THE ESTABLISHMENT REGISTRATION AND LISTING FOR THE CONTACT OFFICE OF THIS DEVICE WAS UPDATED FROM HEALTH ROBOTICS TO OMNICELL S.R.L, WHICH WAS NOT REFLECTED IN THE ORIGINAL REPORT SUBMISSION. THEREFORE, THIS REPORT IS A CORRECTION TO SECTIONS D3 AND G1.

Additional Manufacturer Narrative · 1

UPON INSPECTION OF THE DEVICE BY THE TECHNICIAN, IT WAS DETERMINED THAT THE NEEDLE WAS COMPLETELY BENT. THE INJECTION POSITION OF THE NEEDLE WAS NOT CENTERED AND THE NEEDLE GRIPPERS WERE OF THE OLD STYLE. THE GRIPPERS WERE REPLACED AND THE NEEDLE WAS REPLACED AND RE-CENTERED. THE DEVICE WAS RETURNED TO OPERATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Description of Event or Problem · 1

ON (B)(3), THE USER ATTEMPTED TO PREPARE A TOXOL PREPARATION AND THE ROBOT MISSED THE IV BAG. THIS RESULTED IN A TAXOL SPILL (~25ML) WITHIN THE DEVICE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
451118	OMNICELL I.V. STATION ONCO	PHARMACY COMPOUNDING DEVICE	NEP	OMNICELL, INC.	I.V. STATION ONCO		08056477790014

Patients

Seq	Age	Sex	Outcome	Treatment
1