FDA Adverse Event
Malfunction
Summary report: N
PRIMARY PLUMSET¿, CLAVE¿ PORT, CLAVE¿ Y-SITE
MDR report key: 3242258
·
Received July 15, 2013
Report
- Report Number
- 3242258
- Event Type
- Malfunction
- Date Received
- July 15, 2013
- Date of Event
- June 11, 2013
- Report Date
- July 11, 2013
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MA, US
Narratives
Description of Event or Problem · 1
PATIENT RECEIVED 3 PRE-MEDS THROUGH SECONDARY LINE. WHEN CHEMO CONNECTED, WOULD NOT RUN. THIS HAS HAPPENED TWICE BEFORE AND WE HAVE ELIMINATED THE DIFFERENT SOURCES (PUMP, AIR IN LINE, TUBING ON CHEMO, ETC). IT SEEMS AS IF THE PRIMARY TUBING IS MALFUNCTIONING AT THE SECONDARY CLAVE. ONCE THE PRIMARY TUBING IS CHANGED, THE INFUSION CONTINUES WITHOUT PROBLEM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?MEDICATION FOR CANCER PATIENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 327505 | PRIMARY PLUMSET¿, CLAVE¿ PORT, CLAVE¿ Y-SITE | IV ADMINISTRATION SET | FPA | HOSPIRA, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | HAS HAPPENED TWICE BEFORE AND WE HAVE ELIMINATED| IS MALFUNCTIONING AT THE SECONDARY CLAVE. ONCE THE| ON CHEMO, ETC). IT SEEMS AS IF THE PRIMARY TUBING| WERE REPLACED UNTIL ISSUE WAS RESOLVED. "THIS| THERE WERE OTHER DEVICES BEING USED. ALL DEVICES| THE DIFFERENT SOURCES (PUMP, AIR IN LINE, TUBING| WITHOUT PROBLEM."| PRIMARY TUBING IS CHANGED, THE INFUSION CONTINUES |