DIALOG PLUS
Received Mar 14, 2008 · Event occurred Feb 21, 2008
Report 2523676-2008-00015 · MDR key 1016435
Device
Generic name
Hemodialysis System
Manufacturer
B. Braun Medical, Inc.Model number
NACatalog number
710500K
Lot number
30058
Product problems
- Alarm, audible
- Dislodged
Patient
Not reported
- Therapy/non-surgical treatment, additional
- Treatment with medication(s)
- Blood Loss
Narrative
Description of Event or Problem
AS REPORTED BY THE USER FACILITY: VENOUS NEEDLE BECAME DISLODGED DURING THERAPY AND PATIENT LOST 300CC BLOOD. MACHINE DID ALARM WITH LOW VENOUS PRESSURE ALARM. STAFF RECOGNIZED PROBLEM AND TOOK PROPER ACTION, INCLUDING ADMINISTERING 300CC SALINE. ADDITIONAL INFORMATION PROVIDED BY THE USER FACILITY INDICATED THE NEEDLE WAS NOT PROPERLY SECURED WITH TAPE AND BECAME DISLODGED FROM PATIENT DURING MOVEMENT.
Additional Manufacturer Narrative
SINCE IT WAS REPORTED THE NEEDLE WAS NOT PROPERLY SECURED WITH TAPE AND BECAME DISLODGED FROM THE PATIENT DURING MOVEMENT AND THE MACHINE FUNCTIONED PROPERLY WITH AN ALARM, THIS INCIDENT IS ATTRIBUTED TO USER/PRODUCT INTERACTION.
Remedial action
- Other