Post by Chuck Weddle on Jun 2, 2023 11:00:10 GMT
We've recently had 5 incidences where the pressure line from the arterial POD was obstructed/glued shut (Lot #00VL862418).
To compound this problem, because of the programing, the system passes the blood side pressure test and allows the treatment to be started. Shortly after the treatment is started the machine detects that there is no pulsation in the arterial pressure and alarms (as it should). The alarm can be reset to restart the blood pump which naturally alarms again. Depending on how many times the clinician resets the alarm trying to troubleshoot the the issue, the blood loss could be substantial.
You can easily simulate this by setting up a machine to do a mock treatment and putting a clamp on the arterial pressure line. Note that if there is a problem with the venous pressure line, the machine will not pass the blood side pressure test.
The machine is operating as designed but IMHO, that design is flawed and allows patient injury.
A PIR is filed with Braun and I will wait to see how it is handled before filing MedWatch reports.
To compound this problem, because of the programing, the system passes the blood side pressure test and allows the treatment to be started. Shortly after the treatment is started the machine detects that there is no pulsation in the arterial pressure and alarms (as it should). The alarm can be reset to restart the blood pump which naturally alarms again. Depending on how many times the clinician resets the alarm trying to troubleshoot the the issue, the blood loss could be substantial.
You can easily simulate this by setting up a machine to do a mock treatment and putting a clamp on the arterial pressure line. Note that if there is a problem with the venous pressure line, the machine will not pass the blood side pressure test.
The machine is operating as designed but IMHO, that design is flawed and allows patient injury.
A PIR is filed with Braun and I will wait to see how it is handled before filing MedWatch reports.
