Additional information: d11, h3, h6,h10.The device was received for evaluation.A simulated treatment was performed using the heparin pump (calcium mode) without any problem noted.As a proactive measure, the heparin pump was calibrated.The event history log review showed a general system failure (code 6-syringe pump movement) was identified; however, no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue of unintended shutdown.The reported condition of code 6 was verified.The reported condition of unintended shutdown was not verified.An issued general system failure alarm requires that the prismaflex control unit is restarted.No device failure or malfunction was identified as the device functioned as intended.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
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