FDA Adverse Event
Malfunction
Summary report: N
ALARIS EXTENSION SET
MDR report key: 5043274
·
Received August 31, 2015
Report
- Report Number
- 9616066-2015-01101
- Event Type
- Malfunction
- Date Received
- August 31, 2015
- Date of Event
- August 18, 2015
- Report Date
- August 18, 2015
- Manufacturer
- CAREFUSION
- Product Code
- FPA
- PMA / PMN Number
- K801614
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CORRECTION TO INITIAL REPORTER ADDRESS.
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: ICU MEDICAL NEEDLE-FREE CONNECTOR, MODEL MP1000 , LOT 3053029, THERAPY DATE: (B)(6) 2015. NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT SEQUESTERED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AN EXTENSION SET WAS FOUND DISCONNECTED FROM A NON-CAREFUSION NEEDLE-FREE CONNECTOR DURING AN INFUSION OF TPN TO THE PATIENT RESULTING IN A SMALL AMOUNT OF LEAKAGE OF THE TPN. THE TUBING AND CONNECTOR WERE REPLACED. THERE WAS NO HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 576212 | ALARIS EXTENSION SET | SET, ADMINISTRATION, INTRAVASCULAR | FPA | CAREFUSION | 20028E | 15046695 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |