FDA Adverse Event
Malfunction
Summary report: N
IVAC 597
MDR report key: 3883777
·
Received February 12, 2014
Report
- Report Number
- 2016493-2014-00080
- Event Type
- Malfunction
- Date Received
- February 12, 2014
- Date of Event
- January 27, 2014
- Report Date
- January 29, 2014
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K894037
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PATIENT INFORMATION REQUESTED AND ALL AVAILABLE INFORMATION IS INCLUDED INSPECTION A AND B. THIS REPORT WAS FILED BY THE MANUFACTURER. ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT 1000ML OF 5FU CHEMOTHERAPY INFUSION WAS SET TO INFUSE AT A RATE OF 23 ML/H, HOWEVER, AFTER 36 HOURS THE PATIENT ADVISED THE NURSE THAT THE INFUSION HAD COMPLETED. FROM THE REPORTED INFORMATION, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT. NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 94035 | IVAC 597 | FRN | CAREFUSION CORPORATION | 597 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |