FDA Adverse Event
Malfunction
Summary report: N
GRAVITY ADMINSTRATION SET
MDR report key: 4231884
·
Received October 17, 2014
Report
- Report Number
- 9616066-2014-01024
- Event Type
- Malfunction
- Date Received
- October 17, 2014
- Report Date
- September 29, 2014
- Manufacturer
- CAREFUSION CORP
- Product Code
- FPA
- PMA / PMN Number
- K931173
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
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
CUSTOMER REPORTS PRIMARY GRAVITY SET IS DISCONNECTING FROM MAXPLUS CONNECTOR IN THE OPERATING ROOM. NO PATIENT HARM OR MEDICAL INTERVENTION OCCURRED. NO FURTHER PATIENT/EVENT INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 662001 | GRAVITY ADMINSTRATION SET | IV INFUSION SET | FPA | CAREFUSION CORP | C42013E | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | MAXPLUS CONNECTOR: MODEL/LOT UNK |