TAH Portable Driver: It's Alarming, but is It Broken?

Purpose This report describes an analysis of the complete experience using the Total Artificial Heart (TAH) Portable Driver (PD). Methods Comprehensive de-identified data were obtained from the TAH manufacturer. A review of customer complaints reported to the manufacturer and subsequent failure investigation findings relating to the TAH PD worldwide was conducted for the period 2010 through Q2 2019. A total of 316 PDs entered clinical service to support a total of 403 TAHs during this interval. 1375 PD complaints (835 included reported alarms) were analyzed and grouped by finding, component failure and patient impact. Demographics and outcomes were also reviewed. Results There were over 290 patient years observed. PD complaints: 54.8% (753/1375) were not associated with PD-malfunction, 39.3% (540/1375) were PD malfunctions and 6.0% (82/1375) were related to improper use. Electronic/Electrical components accounted for 51.9% (280/540) with 61.1% (171/280) caused by failure of a humidity-sensitive pressure sensor (replaced by a hermetically-sealed sensor) and 5.7% (31/540) by failure of the piston cylinder assembly. 60.7% (835/1375) of PD complaints reported device alarms: 55.2% (461/835) were not associated with malfunction, 6.3% (53/835) were attributed to improper use, and 38.4% (321/835) were device malfunctions. 64.8% (261/403) of patients were discharged. 74.9% (302/403) of all PD patients and 77% (201/261) of discharged PD patients were alive on device or had been transplanted. Of 540 confirmed driver malfunctions, 92.4% (1271/1375) had no patient impact, 4.1% (57/1375) reported an adverse event (AE), 2.6% (36/1375) reported a serious AE and 0.07% (11/1375) reported a death. Conclusion The majority of alarms and complaints are not associated with device malfunction. Overall safety and durability of the TAH Portable Driver is demonstrated by the low incidence of negative patient impact when device malfunctions do occur and an excellent BTT rate for PD patients.