FDA Adverse Event
Malfunction
Summary report: N
OMNICELL I.V.STATION ONCO
MDR report key: 10417824
·
Received August 17, 2020
Report
- Report Number
- 3011278888-2020-00019
- Event Type
- Malfunction
- Date Received
- August 17, 2020
- Date of Event
- July 21, 2020
- Report Date
- May 21, 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 (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 A SPILL INVOLVING THE CHEMOTHERAPY DRUG PREPARATION PACLITAXEL OCCURRED INSIDE THE I.V. STATION ONCO DEVICE. THE SPILL, WHICH WAS CREATED AS A RESULT OF MISALIGNMENT BETWEEN THE SYRINGE AND INJECTION POINT DURING DOSING, WAS IDENTIFIED AND SUBSEQUENTLY CLEANED BY THE USER. ADJUSTMENTS WERE MADE TO THE ROBOT POINT FOR SYRINGE INSERTION TO PREVENT RECURRENCE. 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 |
|---|---|---|---|---|---|---|---|
| 878040 | OMNICELL I.V.STATION ONCO | PHARMACY COMPOUNDING DEVICE | NEP | OMNICELL, INC. | I.V. STATION ONCO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |