FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE
MDR report key: 2890634
·
Received November 21, 2012
Report
- Report Number
- 2016493-2012-00499
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Date of Event
- October 2, 2012
- Report Date
- November 5, 2012
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K950419
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE AFFECTED PRODUCT HAS BEEN REC'D AND THE INVESTIGATION IS PENDING. A F/U REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
CUSTOMER REPORTED UNREGULATED FLOW, STATED A BAG OF CARDIAC MEDICATION EMPTIED ALL AT ONCE. NO REPORT OF PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. THE CUSTOMER DID NOT PROVIDE ANY ADD'L PT OR EVENT INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS PUMP MODULE | FRN | CAREFUSION CORPORATION | 8100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ALARIS PC UNIT, SN UNK| ALARIS PUMP MODULE ADMIN SET, MODEL/LOT # UNK |