Computer Software Expert Evaluates Medical Device Function

This case involves a 50-year-old male patient who was receiving at-home peritoneal dialysis treatments. While undergoing dialysis he became ill, and his wife drove him to the nearest hospital emergency room. Unfortunately, he suffered cardiac arrest and never regained consciousness. A little more than two weeks following his death, the family received an “urgent product information” letter from the medical care company. The company warned about the risk of increased intra-peritoneal volume/overfill that can result in serious injury or death. Sadly, this letter arrived too late to help the decedent. The software that came with the device is now in the attorney’s possession. We understand that a wealth of information can be obtained from the software; in order to retrieve that information, we will need to have the correct software package to access this data. Plaintiff’s counsel seeks an expert who has access to proprietary software that will allow the drive to be read and interpreted.

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 mentioned? 3) Have ever served as an expert witness on a case similar to the one described above?

Expert Witness Response E-007774

I have decades 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. It may be sufficient to know the version number of the installed software. The software, if needed, may be subpoenaed from the manufacture. Some analysis needs to be done for us to determine what information is needed and how it would be best obtained.