FDA Adverse Event
Malfunction
Summary report: N
ALARIS EXTENSION SET
MDR report key: 2101926
·
Received May 18, 2011
Report
- Report Number
- 9616066-2011-00245
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Report Date
- April 19, 2011
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FPA
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
MFR'S REPORT DATE: 05/18/2011. (B)(4). PRODUCTS HAVE BEEN RECEIVED BUT NOT YET EVALUATED. A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
PICU CLINICIAN REPORTED "LEAKING" NOTE WAS ALL THE INFO AVAILABLE ON BAG WITH A BUNCH OF TUBING ON HER DESK. IT LOOKS LIKE SET MODEL # 30914. NO EVENT/PT INFO. THERE IS NO DATE/TIME ON THE NOTE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS EXTENSION SET | FPA | CAREFUSION CORP. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ALARIS SYRINGE MODULE: SERIAL # UNK| ALARIS PC UNIT: SERIAL # UNK |