Manufacturer's investigation conclusion: the evaluation of the returned portion of the driveline confirmed wire damage that would have contributed to the reported pump stop events that were captured in the submitted log file.The pump was returned assembled with the driveline (dl) cut approximately 1.25¿ from the pump housing and the distal portion of the dl was returned.The sealed inflow conduit (inlet tube, flex section, and inlet elbow) was returned detached from the pump¿s inlet port.The sealed outflow graft and outflow graft bend relief were not returned.The outflow elbow was returned attached to the pump¿s outlet port.Visual examination of the pump¿s blood-contacting surfaces upon disassembly of (b)(6) revealed no evidence of depositions or thrombus formations.Electrical continuity testing did not reveal any discontinuities.The silicone jacket and clear bionate appeared unremarkable.Visual inspection of the returned portions of the driveline revealed minor breakdown of the metal braided shield throughout the length of the driveline.Visual examination of the underlying wires revealed breaches in the insulation of orange and yellow wires 2.5¿ from the pump housing, exposing the inner conductors.The observed wire damage appeared consistent with fatigue failure due to repetitive flexing and abrasion against the metal braided shield.Both segments of the driveline were then submerged in a saline solution for hi-pot testing to further verify the integrity of each wire's insulation.The test did not reveal any additional breaches.If the exposed conductors of the compromised wires contacted the braided shield while the system was connected to a tethered power source (such as the power module) using a grounded patient cable, the resulting electrical short to ground would have caused the reported pump stoppages as captured in the submitted log file.The system also had the potential for an electrical short to occur on battery power and cause an interruption in pump function if the exposed conductors of both compromised wires made simultaneous contact with the braided shield.No further information was provided.The manufacturer is closing the file on this event.
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