Model Number 42648-06 |
Device Problems
Disconnection (1171); Connection Problem (2900)
|
Patient Problem
Chemical Exposure (2570)
|
Event Date 07/29/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device was returned.Visual inspection: the as-received 42648-06 set was primed.The safeset reservoir tubing was found to be disconnected from the pressure tubing.The bonded connection was examined under a microscope and an incomplete solvent ring was found around the tubing connection.Function inspection: the other end of the device was pull tested per the product specification and the tubing met product performance specification.Analysis summary: the reported problem of tubing detachment was confirmed as insufficient solvent.A two year review of complaints database revealed one additional report for 42648-06/similar problem.
|
|
Event Description
|
Safeset reservoir was being pulled back to draw blood.While the reservoir was being drawn back, the tubing connected to the blood sampling port detached.This gave an open area where blood was run out freely from the arterial line.The tubing was quickly reattached, and then changed out completely.No adverse patient consequences were reported.
|
|
Manufacturer Narrative
|
Device was returned.Visual inspection: the as-received 42648-06 set was primed.The safeset reservoir tubing was found to be disconnected from the pressure tubing.The bonded connection was examined under a microscope and an incomplete solvent ring was found around the tubing connection.Function inspection: the other end of the device was pull tested per the product specification and the tubing met product performance specification.Analysis summary: the reported problem of tubing detachment was confirmed as insufficient solvent.A two year review of complaints database revealed one additional report for 42648-06/similar problem.
|
|
Event Description
|
The user facility reports on a medsun report (b)(4) that safeset reservoir was being pulled back to draw blood.While the reservoir was being drawn back, the tubing which is connected to the blood sampling port detached.Blood leaked freely from the arterial line.The tubing was quickly reattached, and then changed out completely.No adverse patient consequences were reported.The device was returned and visual examination confirmed the complaint of tubing separating from the sample port.The bonded connection was examined and found to have an incomplete solvent ring around the tubing.The reported product problem for tubing detachment was confirmed.
|
|
Search Alerts/Recalls
|