FDA Adverse Event
Malfunction
Summary report: N
OMNICELL I.V.STATION ONCO
MDR report key: 9758459
·
Received February 26, 2020
Report
- Report Number
- 3011278888-2020-00004
- Event Type
- Malfunction
- Date Received
- February 26, 2020
- Date of Event
- February 4, 2020
- Report Date
- May 18, 2021
- Manufacturer
- OMNICELL, INC.
- Product Code
- NEP
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
AS OF (B)(6) 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 MULTIPLE SPILLS INVOLVING CHEMOTHERAPY DRUG PREPARATIONS OCCURRED INSIDE THE I.V. STATION ONCO DEVICE. THE SPILLS WERE IDENTIFIED AND SUBSEQUENTLY CLEANED BY THE USER. THE NEEDLE GUIDANCE PINCERS USED IN THE BAG INJECTION PROCESS WERE NOT FUNCTIONING CORRECTLY, WERE FOUND TO BE DIRTY AND WERE CLEANED TO RESTORE PROPER FUNCTIONALITY AND PREVENT RECURRENCE. THERE IS NO ADVERSE PATIENT EFFECT RELATED TO THESE DRUG SPILLS WITHIN THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 220261 | OMNICELL I.V.STATION ONCO | PHARMACY COMPOUNDING DEVICE | NEP | OMNICELL, INC. | I.V. STATION ONCO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |