FDA Adverse Event
Malfunction
Summary report: N
ALARIS PCA MODULE ADMINISTRATION SET
MDR report key: 3222019
·
Received July 3, 2013
Report
- Report Number
- 9616066-2013-00500
- Event Type
- Malfunction
- Date Received
- July 3, 2013
- Date of Event
- June 13, 2013
- Report Date
- June 14, 2013
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K811885
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SET CRACKED AND LEAKED AT THE PT END. TAPE WAS PUT AROUND THE CRACKED AREA. THE SET WAS IN USE 1-2 HOURS. THEE WAS NO PT HARM OR MEDICAL INTERVENTION. THE CUSTOMER STATED THAT NO FURTHER PT/EVENT INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303541 | ALARIS PCA MODULE ADMINISTRATION SET | FPA | CAREFUSION CORPORATION | 30873 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ALARIS PC UNIT: SN UNK| PCA MODULE: SN UNIK |