Peritoneal Dialysis Patient is Killed by Overfill of Intraperitoneal Volume

    This case involves a 52-year-old man who was receiving home peritoneal dialysis treatments after suffering from an acute kidney injury after a motorcycle accident. While undergoing dialysis he became ill and his daughter immediately rushed him to the hospital. However, while he was being treated he suffered cardiac arrest and died. Following his death, the family received a product information warning from the company that made the dialysis machine, dated a month after his death. In the warning, the company stressed the risk of overfill of intraperitoneal volume that can result in death. The family wanted to review the information from the machine’s software that may indicate wrongful death, but did not have the necessary software package to read the data.

    Question(s) For Expert Witness

    • 1. Do you have access to the necessary software?
    • 2. Have you ever extracted this type of data, using the software package?

    Expert Witness Response E-007774

    I have over 30 years of experience in complex medical technology, including device software development, regulatory compliance, risk analysis and consulting. Whether or not we can read the software depends on what information is needed. Historical operation logs may be available from the machine in question. Some analysis needs to be done for us to determine what information is needed and how it would be best obtained. That would be part of the research engagement. We would start with the information already in possession and what is available publicly.

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