FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP ADMINISTRATION SET
MDR report key: 2113597
·
Received May 24, 2011
Report
- Report Number
- 9616066-2011-00246
- Event Type
- Malfunction
- Date Received
- May 24, 2011
- Date of Event
- January 29, 2011
- Report Date
- February 2, 2011
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(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 MANUFACTURING ISSUE DUE TO INSUFFICIENT SOLVENT. THE DISCOLORATION OBSERVED ON THE DRIP CHAMBER IS DUE TO GAMMA STERILIZATION PROCESS.
Description of Event or Problem · 1
CUSTOMER REPORTED IV LINE WAS NOT INFUSING AT TIME OF THE EVENT. IV LINE WAS PRIMED AND RN NOTICED THAT THE WAS WET. THE NURSE NOTICED DISCOLORATION OF DRIP CHAMBER ON IV SET. RN REMOVED LINE THAT WAS UTILIZED ON PT AS A PRECAUTION AND REPLACED IT. CUSTOMER STATES THAT NO FURTHER PATIENT/EVENT INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS PUMP ADMINISTRATION SET | FPA | CAREFUSION CORPORATION | 2420-0007 | 08065553 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |