FDA Adverse Event
Malfunction
Summary report: N
ONE LINK NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLAC
MDR report key: 3893464
·
Received June 13, 2014
Report
- Report Number
- 3893464
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Date of Event
- June 3, 2014
- Report Date
- June 13, 2014
- Manufacturer
- BAXTER HEALTHCARE CORP.
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
PATIENT'S BLOOD PRESSURE DROPPED. ADMINISTERED LEVOPHED AS THE MAXIMUM DOSE AROUND 100ML/HR, USING IV PUMP THROUGH CENTRAL LINE. PATIENT DID NOT RESPOND; BLOOD PRESSURE CONTINUED TO DROP. IV PUMP FAILED TO ALARM DOWNSTREAM OCCLUSION. REMOVED ONE LINK NEEDLE-FREE IV CONNECTOR; PATIENT'S BLOOD PRESSURE IMPROVED. ABLE TO TITRATE DOWN ON MEDICATION.THIS FACILITY HAS HAD MULTIPLE PROBLEMS WITH THE ONE-LINK DEVICE. LINE PATENCY IS CONFIRMED, BUT WITH THE ONE-LINK IN PLACE, FLUIDS WILL NOT INFUSE VIA PUMP AND STAFF HAVE DIFFICULTY PUSHING IV MEDS/FLUID VIA SYRINGE. WHEN THE ONE-LINK IS REMOVED, THERE IS NO DIFFICULTY DELIVERING THE FLUIDS/MEDICATIONS IN THE SAME LINES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351385 | ONE LINK NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLAC | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE CORP. | 7N8399 | * | |
| 351386 | BAXTER SIGMA SPECTRUM | PUMP, INFUSION | FPA | BAXTER HEALTHCARE CORP. | 35700 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |