FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP ADMINISTRATION SET
MDR report key: 2113598
·
Received May 24, 2011
Report
- Report Number
- 9616066-2011-00247
- Event Type
- Malfunction
- Date Received
- May 24, 2011
- Date of Event
- January 29, 2011
- Report Date
- February 2, 2011
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FPA
- PMA / PMN Number
- K5944320
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MFR'S REPORT DATE: (B)(4) 2011. (B)(4). THE CUSTOMER'S COMPLAINT OF A LEAK WAS CONFIRMED. LEAKING WAS OBSERVED AT THE ENGAGEMENT BETWEEN THE NITRO TUBING AND THE UPPER FITMENT. THE ROOT CAUSE OF THE LEAK WAS IDENTIFIED AS A MFG ISSUE DUE TO INSUFFICIENT SOLVENT. THE DISCOLORATION OBSERVED ON THE DRIP CHAMBER IS DUE TO GAMA STERILIZATION PROCESS. CUSTOMER REPORTED LOT 08065553 (MFG 06/2008), HOWEVER, SMARTSITE LASER NUMBER ON SET RECEIVED INDICATES IT WAS MFG 5/2008, LOT UNK.
Description of Event or Problem · 1
CUSTOMER REPORTED DEFECTIVE MAINTENANCE IV SET. LEAKAGE NOTED TO BLUE AREA THAT GETS INSTALLED INTO IV PUMP CHANNEL. DRIP CHAMBER ALSO NOTED TO BE DISCOLORED - BROWN. CUSTOMER STATES THAT NO FURTHER PT/EVENT INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS PUMP ADMINISTRATION SET | FPA | CAREFUSION CORP. | 2420-0007 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |