FDA Adverse Event
Malfunction
Summary report: N
ALARIS EXTENSION SET
MDR report key: 2140719
·
Received June 15, 2011
Report
- Report Number
- 9616066-2011-00331
- Event Type
- Malfunction
- Date Received
- June 15, 2011
- Report Date
- May 19, 2011
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K790108
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PRODUCT WAS EVALUATED AND CUSTOMER'S COMPLAINT OF LEAKING IS NOT CONFIRMED. THE COMPONENT WAS INSPECTED AND NO ANOMALIES WERE FOUND. FUNCTIONAL TESTING WAS UNABLE TO DUPLICATE THE CUSTOMER'S ISSUE. ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.
Description of Event or Problem · 1
PICU CLINICIAN REPORTED "LEAKING" NOTE ON BAG WITH A BUNCH OF TUBING ON HER DESK. IT APPEARS TO BE SET MODEL 30914. NO EVENT/PATIENT INFORMATION AVAILABLE. THERE IS NO DATE OR TIME ON THE NOTE. A TOTAL OF 3 SETS WERE RECEIVED, THIS IS THE SECOND OF THE THREE SETS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS EXTENSION SET | FPA | CAREFUSION CORPORATION | 30914 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |