n
The fibers in the device may leak during use (red discoloration in the filtrate collection bag).
This can lead to blood loss and limit the filtration performance.
–
Replace the device or stop hemoconcentration in the event of leaks, clotting or if blood
escapes.
–
Make sure a replacement device is available at all times.
n
If the active ingredient level of the drugs administered is too high, this can trigger a toxic or
allergic reaction in the patient.
–
Monitor the electrolyte values and the active ingredient level of all drugs administered
during and after the hemoconcentration.
–
Soluble substances administered for therapeutic purposes may be eliminated with the
filtrate.
–
High molecular or protein-bound therapeutic agents may become concentrated in the
blood.
–
An electrolyte imbalance can cause cardiac arrhythmias in the patient.
n
If the collection bag for the filtrate is positioned incorrectly, this can lead to an increase in
transmembrane pressure. This can result in increased hemolysis and reduced filtration per-
formance.
–
Position the collection bag for the filtrate significantly lower than the hemoconcentra-
tor. This increases the filtration performance (due to gravity) and prevents a backflow of
filtrate.
n
Exceeding the permissible minimum and maximum values for the pressures and blood flow
can cause leaks and damage to the device. This can lead to embolisms, hemolysis and infec-
tions in the patient.
–
To ensure effective filtration, make sure there is a sufficient pressure gradient between
the blood-carrying side and the filtrate side.
–
Monitor the pressure at the blood inlet and blood outlet as this can provide an indica-
tion about a possible unwanted increase in transmembrane pressure, if applicable.
–
Configure an alarm or an automatic pump stop in order to avoid the maximum permissi-
ble transmembrane pressure being exceeded, if applicable.
–
Do not allow the blood flow to fall below the minimum blood flow for the hemoconcen-
trator specified by the manufacturer. This prevents hemostasis and reduces clotting.
–
The effectiveness can be increased by applying an adjustable vacuum. Be aware that a
vacuum on the filtrate side increases the transmembrane pressure.
n
Hemostasis can develop in the patient during the procedure.
–
Prevent hemostasis in the patient during the entire procedure.
–
Regularly check whether there are signs of coagulation in the patient.
n
If the balance of fluid is disrupted, this can cause hypervolemia or hypovolemia. This can re-
sult in serious injuries to or death of the patient.
–
Ensure a stable balance of fluid.
–
Control the filtrate volume over the time. Collect the filtrate in a disposable bag with vol-
ume display or measure the weight of the fluid which has accumulated over the time.
n
If the volume and quantity of ultrafiltrate is insufficient, this can, depending on the condition
of the patient, lead to inadequate patient support.
–
The volume and quantity of ultrafiltrate must be closely monitored by the anesthetist,
perfusionist or attending physician.
–
Visually check the volume at the filter bag continuously. The volume cannot be defined
in advance.
–
Measure the hematocrit, hemoglobin and the electrolyte values downstream of the oxy-
genator before the blood is pumped back into the patient.
n
If the device is defective, this can result in serious injuries to or death of the patient.
–
During use, check the filtrate continuously for signs of yellowish or reddish discol-
oration. These are indications of a fiber tear.
–
Replace the device if discoloration of the filtrate is evident.
| BC 20 plus / BC 60 plus / BC 140 plus | 11 |
Instructions for Use | 2.7 | G-153 | 07
en