FDA Adverse Event
Malfunction
Summary report: N
GEMINI ADMINISTRATION SET
MDR report key: 2121143
·
Received May 4, 2011
Report
- Report Number
- 9616066-2011-00138
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Date of Event
- December 21, 2010
- Report Date
- December 21, 2010
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K931173
- 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). THE CUSTOMER'S EXPERIENCE WAS CONFIRMED. A LEAKAGE WAS IDENTIFIED FROM A SPLIT IN THE PUMPING SEGMENT TUBING. ROOT CAUSE OF THE LEAK WAS UNDETERMINED.
Description of Event or Problem · 1
THE USER REPORTED NOTICING A POOL OF FLUID UNDER THE PUMP AND LIQUID DRIPPING FROM THE BOTTOM OF THE PUMP. ON CLOSER INSPECTION, THE CLINICIAN NOTICED A LEAK NEAR THE UPPER PUMPING SEGMENT SECTION OF THE SET. FROM THE REPORTED INFORMATION, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEMINI ADMINISTRATION SET | FPA | CAREFUSION CORPORATION | 2200-0500 | 10065007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |