FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 3052064
·
Received March 29, 2013
Report
- Report Number
- 3052064
- Event Type
- Malfunction
- Date Received
- March 29, 2013
- Date of Event
- January 18, 2012
- Report Date
- March 29, 2013
- Manufacturer
- MEDELA, INC.
- Product Code
- HGX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ, US
Narratives
Description of Event or Problem · 1
MILK WAS NOTED IN THE TUBING AFTER INITIATION OF PUMPING MILK FOR THE PATIENT IN THE NICU. RN TRIED TO REMOVE MILK IN THE TUBING BY FLUSHING WITH WATER AND THEN REPLACED THE TUBING WITH A NEW KIT. THE NEXT DAY, MILK WAS NOTED AGAIN IN THE NEW TUBING. EQUIPMENT INCLUDING PUMP AND TUBING, WAS THEN REMOVED AND REPLACED WITH DIFFERENT DEVICE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?FEEDING AN INFANT IN THE NICU.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 130022 | * | PUMP, BREAST,POWERED | HGX | MEDELA, INC. | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 DA |