FDA Adverse Event
Malfunction
Summary report: N
LIFESHIELD VENTED SECONDARY W/BLUNT CANNULA
MDR report key: 1061822
·
Received June 13, 2008
Report
- Report Number
- 9613251-2008-00174
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Date of Event
- April 1, 2008
- Report Date
- May 19, 2008
- Manufacturer
- HOSPIRA LTD
- Product Code
- FPA
- PMA / PMN Number
- K912103
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER INDICATED THE DEVICES WERE DISCARDED.
Description of Event or Problem · 1
GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF NO FLOW. THE SECONDARY TUBING SETS WERE CONNECTED TO THE PROXIMAL PORTS OF UNSPECIFIED PRIMARY TUBING SETS AND WERE BEING USED FOR PIGGYBACK DELIVERIES OF UNSPECIFIED ANTIBIOTICS VIA UNSPECIFIED PUMPS. THE PRIMARY SOLUTION CONTAINERS WERE LOWERED BELOW THE SECONDARY SOLUTION CONTAINERS AND THE DELIVERIES WERE STARTED. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, THE NURSES NOTED THAT THE ANTIBIOTICS HAD NOT DELIVERED. THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESHIELD VENTED SECONDARY W/BLUNT CANNULA | 80-FPA | FPA | HOSPIRA LTD | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | UNSPECIFIED COLLEAGUE PUMPS| UNSPECIFIED PRIMARY TUBING SETS MFG BY BAXTER INTL |