Bruce H. Barkalow, Ph.D., PE, CCE
490 Quarterline SE
Newaygo, MI 49337-9201
Tel: (231) 652-2228
Fax: (231) 652-7912
Email: bhbi@riverview.net 
Web page: www.bhbi.com 

No.

Client Type

Anesthetic Overdose Injury - Alleged User Errors

 Year

2 Plaintiff Law Firm Case Basics:  A 3 year-old boy was admitted for routine hernia surgery in a community hospital.  During the procedure he was overdosed with halothane and suffered from low cardiac output.  After resuscitation, the patient was found to have extensive permanent brain damage resulting in spastic quadriplegia.

Plaintiff's Technical Allegations:  The overdose was a result of  a key-filled vaporizer having been over filled by a hospital OR technician.  The over filling technique was taught to him by the manufacturer representative as a means to rapidly fill the vaporizer.  When the vaporizer was over filled, liquid halothane was dispensed into the breathing circuit early in the induction phase.

BME Work:  The first item of interest was the discovery that all 24 vaporizers at the hospital had been overfilled.  There may have been other incidents of anesthetic overdose.  Using one of the anesthesia machines, the vaporizer was filled according to the "short cut" filling technique.  Using a pediatric test lung and a mass spectrometer to monitor gas composition in a breathing circuit, incident simulation revealed a vaporizer setting of 1.5% could deliver over 21% halothane.  Investigation of user training and product labeling revealed inadequacies in adherence to proper filling techniques related to patient safety.  The vaporizer design was found to be defective with respect to lack of a designed but not implemented overfill spill hole.  The hospital did not use anesthetic gas monitors and did not have a thorough appreciation of how to use their existing monitoring equipment properly including non invasive blood pressure, pulse oximetry, and ECG monitors.

Outcome:  After submission of the expert report and those of the consulting physicians, the case went into settlement.  Later, the hospital acquired anesthetic gas monitoring capabilities.  The key-filled vaporizer filling technique was changed in accordance with correct protocols.

Relevance:  Cases where a young patient is seriously brain damaged in a routine medical procedure but who has a long life expectancy are generally the most costly.  The routine use of anesthetic gas monitors and proper training on the other standard monitors for the medical staff is extremely important.  Proper care and good technique for using and maintaining medical devices is a critical part of adequate healthcare delivery.

1991
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