FDA Adverse Event
Malfunction
Summary report: N
ALARIS PRIMARY ADMINISTRATION SET
MDR report key: 2082565
·
Received April 27, 2011
Report
- Report Number
- 9616066-2011-00158
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Report Date
- March 31, 2011
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER'S REPORT DATE: APRIL 27, 2011. (B)(4). THE SET WAS DISCARDED AT THE FACILITY. THE MODEL AND THE LOT NUMBER WERE NOT IDENTIFIED.
Description of Event or Problem · 1
CUSTOMER'S ANECDOTAL REPORT OF A TUBING SEPARATION WHICH OCCURRED SOMETIME IN 2010, THE DATE IS UNKNOWN. THE NURSE EXPERIENCED REOCCURRING AIR IN THE LINE ALARMS EVEN AFTER ENSURING THAT ALL OF THE AIR HAD BEEN REMOVED. SHE PULLED UP ON THE TUBING AT THE UPPER FITMENT TO "FLICK" OUT ANY POTENTIAL AIR WHEN IT SEPARATED AT THE SAFETY CLAMP. IT WAS STATED THE TUBING CAME APART VERY EASILY. THE PRODUCT WAS ON A PATIENT AT THE TIME OF THE EVENT. FROM THE REPORTED INFORMATION, THERE ARE NO INDICATIONS OF SERIOUS INJURY AS A RESULT OF THIS INCIDENT. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS PRIMARY ADMINISTRATION SET | FPA | CAREFUSION CORPORATION | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |