30
Device Malfunctions and Failures
Four device malfunctions and no device failures were reported in the clinical studies as shown in Table 13. The one report of device
malfunction during the Pivotal FTW study involved a blood pump stoppage that occurred due to thrombosis in the outflow cannula
during the patient weaning process, rendering lowered pump flow settings and pharmacological anticoagulation. In each of the pilot
studies, a malfunction involving the motor making noises occurred; in each case, the motor and console were switched out with the
backup units, resolving the issue. The final reported device malfunction occurred in the Cardiogenic Shock Pilot Trial, in which a
stopcock on the outflow circuit of the right side pump in a BiVAD patient popped off. The circuit was temporarily clamped off, and the
stopcock was replaced.
Because data on device malfunctions and failures in the clinical studies were limited due to the size of the studies, post-market safety
data for the CentriMag system were also used to evaluate the safety of the device. These data were obtained by analyzing adverse
events associated with marketed CentriMag systems which were reported to Abbott Medical between June 1, 2014, and June 30,
2019. The results from these Medical Device Reports (MDRs) are summarized Table 14.
Over 32,000 CentriMag pumps were distributed during that same time period, providing a reasonable estimate of the number of times
that the CentriMag system is used, the denominator used to calculate the incidence of these events.
Table 14. MDR Reports: CentriMag Circulatory Support System Adverse Events by Component (June 2014 – June 2019)
CentriMag System Component
No. of Events
Motor
Motor cable break
60
System stopped
25
Overheating
20
Abnormal sounds
12
Abnormal operation
4
Variable flow
1
Total
122
Console
System Alarm(s)/Fault (console and/motor)
68
Abnormal operation
10
System stopped
4
Battery
2
Total
84
Pump (Adult and Pediatric)
Thrombus
20
Variable flow
11
Damage
2
Blood leak
1
Death
1
Unknown/Other
1
Total
36
Cannula
Blood leak (cannula connector)
8
Detachment (cannula color band)
4
Decannulation
1
Total
13
Multiple/Indeterminate Component(s)
Stroke
7
Death
5
Unknown/Other
5
Physical Damage
4
Infection
3
Air entrainment
3
Hemolysis
2