FDA Adverse Event
Malfunction
Summary report: N
ALARIS PCA MODULE ADMINISTRATION SET
MDR report key: 3940422
·
Received April 17, 2014
Report
- Report Number
- 9616066-2014-00331
- Event Type
- Malfunction
- Date Received
- April 17, 2014
- Date of Event
- March 14, 2014
- Report Date
- March 21, 2014
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K811885
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER'S REPORT DATE: 04/17/2014. (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORT THAT TUBING WAS LEAKING. THE CUSTOMER STATED THE SET HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED "STEP-DOWN UNIT NURSE (SDU) NOTIFIED PHARMACIST PCA TUBING AND LEAKING AND NEEDED REPLACEMENT. REPLACED TUBING, PT REPORTS GOOD PAIN CONTROL AND HAD NO OTHER COMPLAINTS". THERE WAS NO PT HARM OR MEDICAL INTERVENTION. NO FURTHER PATIENT/EVENT INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235709 | ALARIS PCA MODULE ADMINISTRATION SET | FPA | CAREFUSION CORPORATION | 30853 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ALARIS PC UNIT, SN UNK| PCA MODULE, SN UNK |