FDA Adverse Event
Malfunction
Summary report: N
ALARIS GEMINI ADMINISTRATION SET
MDR report key: 3043437
·
Received March 13, 2013
Report
- Report Number
- 9616066-2013-00141
- Event Type
- Malfunction
- Date Received
- March 13, 2013
- Date of Event
- February 12, 2013
- Report Date
- February 22, 2013
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ADMINISTRATION SET INVOLVED IN THIS EVENT WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE CUSTOMER. NO FAILURE INVESTIGATION COULD BE PERFORMED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT FOLLOWING A CHEMOTHERAPY INFUSION, "THE SILICON SEGMENT (UPPER) HAS SPLIT/DETACHED FROM THE MAIN LINE WHEN THE LINE WAS BEING REMOVED FROM THE GEMINI PUMP". FROM THE REPORTED INFO, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PT OR USER AS A RESULT OF THIS INCIDENT. NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106155 | ALARIS GEMINI ADMINISTRATION SET | FPA | CAREFUSION CORP. | 2200-0500 | 12106230 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | ALARIS GEMINI PUMP, SN UNKNOWN |