FDA Adverse Event
Malfunction
Summary report: N
OMNICELL I.V.STATION ONCO
MDR report key: 10511441
·
Received September 9, 2020
Report
- Report Number
- 3011278888-2020-00024
- Event Type
- Malfunction
- Date Received
- September 9, 2020
- Date of Event
- August 17, 2020
- Report Date
- May 25, 2021
- Manufacturer
- OMNICELL, INC.
- Product Code
- NEP
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
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 A CHEMOTHERAPY DRUG PREPARATION OCCURRED INSIDE THE I.V. STATION ONCO DEVICE. THE DEVICE IDENTIFIED THE SPILL AND NOTIFIED THE USER WHO SUBSEQUENTLY CLEANED THE SPILL. THE CAUSE OF THE SPILL COULD NOT BE DETERMINED; NO MODIFICATIONS WERE MADE TO THE DEVICE. 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 |
|---|---|---|---|---|---|---|---|
| 972020 | OMNICELL I.V.STATION ONCO | PHARMACY COMPOUNDING DEVICE | NEP | OMNICELL, INC. | I.V. STATION ONCO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |