FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE ADMINISTRATION SET
MDR report key: 3134001
·
Received May 1, 2013
Report
- Report Number
- 9616066-2013-00316
- Event Type
- Malfunction
- Date Received
- May 1, 2013
- Report Date
- April 11, 2013
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE HAS BEEN RECEIVED BUT IT HAS NOT BEEN EVALUATED YET. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHEN THE PATIENT WENT TO THE REST ROOM, A WET MARK WAS NOTED ON THE BEDSHEET. WHEN CHECKED, A LEAK WAS FOUND AT THE ALARIS FILTER BASE. THE PATIENT'S CLOTHING SHOWED NO SIGN OF CONTAMINATION. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 190987 | ALARIS PUMP MODULE ADMINISTRATION SET | FPA | CAREFUSION CORPORATION | 10015048 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |