FDA Adverse Event
Malfunction
Summary report: N
OMNICELL I.V.STATION ONCO
MDR report key: 9758495
·
Received February 26, 2020
Report
- Report Number
- 3011278888-2020-00005
- Event Type
- Malfunction
- Date Received
- February 26, 2020
- Date of Event
- February 4, 2020
- Report Date
- May 19, 2021
- Manufacturer
- OMNICELL, INC.
- Product Code
- NEP
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
AS OF JANUARY 2020, THE ESTABLISHMENT REGISTRATION AND LISTING FOR THIS DEVICE WAS UPDATED TO OMNICELL, INC. FROM AESYNT, INC, WHICH WAS NOT REFLECTED IN THE ORIGINAL REPORT SUBMISSION. THEREFORE, THIS REPORT IS A CORRECTION TO THE MANUFACTURER LISTED IN SECTIONS D3 AND G1.
Description of Event or Problem · 1
ON (B)(6) 2020 A SPILL INVOLVING A CHEMOTHERAPY DRUG PREPARATION OCCURRED INSIDE THE I.V. STATION ONCO DEVICE. THE SPILL WAS IDENTIFIED AND SUBSEQUENTLY CLEANED BY THE USER. NO PRODUCT ISSUE WAS OBSERVED UPON INVESTIGATION. THERE IS NO ADVERSE PATIENT EFFECT RELATED TO THIS DRUG SPILL WITHIN THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 216691 | OMNICELL I.V.STATION ONCO | PHARMACY COMPOUNDING DEVICE | NEP | OMNICELL, INC. | I.V. STATION ONCO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |