Blood Pressure Cuff Malfunction Causes Crush Syndrome

This case involves a case of crush syndrome resulting from continuous compression of the upper arm by a dysfunctional automatic cycle blood pressure cuff. The patient was in a postoperative recovery room where he was connected to continuous monitoring devices, which included an automatic blood pressure cuff. The cuff maintained pressure for three full days, and when it was finally removed, the patient’s arm was severely discolored beneath the cuff margins. Despite the wound on his arm, the patient was discharged from the hospital. He followed up with his family doctor who referred him to a burn center. The patient had to undergo several debridement procedures to remove necrotic skin tissue and two skin graft procedures to heal the open wound. Following the procedure, the patient experienced limited range of motion of the limb below the elbow, coupled with sensory nerve deficits.

Question(s) For Expert Witness

1. Would you be able to determine if the malfunctioning of the device is within the standards of practice, as indicated by the label?

Expert Witness Response E-004870

This is an interesting case. I work with automatic BP monitors all the time on FDA submissions. I am qualified to review the device labeling and determine if the warnings were sufficient. If the device did not explain the risk properly for leaving the cuff on too long, than this would be a problem. I have been involved in the field of medical technologies for over thirty years and have ample experience with matters concerning FDA compliance. I am also the vice president of a private medical technologies firm, which would qualify me to comment on the case at hand.