Fentanyl Overdose Caused by Malfunction of SynchroMed II Intrathecal Pump

Abstract

We present 2 cases of intrathecal pump malfunction, which most likely led to overinfusion of fentanyl intrathecally. To reduce the risk of this complication, particular attention should be paid to drug reservoir volume discrepancies and overdose symptoms reported by patients.

The Polyanalgesic Consensus Conference (PACC): Recommendations for Intrathecal Drug Delivery: Guidance for Improving Safety and Mitigating Risks

“…The residual volume in the pump was 16 mL instead of the expected 19.6 mL. Examination of the explanted pump revealed residue, moisture and corrosion, with deformity of the inner tube lining around the roller head, with insufficient tube compression preventing continual infusion of drug out of the pump, likely leading to overinfusion . Other causes for residual volume discrepancies include a partial pocket fill and/or a previously improperly measured fill.…”

Tailoring Formulations for Intranasal Nose-to-Brain Delivery: A Review on Architecture, Physico-Chemical Characteristics and Mucociliary Clearance of the Nasal Olfactory Mucosa

“…A chronic drug supply can be provided by implanted medical devices. Although, such techniques are in clinical use, these routes of administration are invasive and their use is predominantly limited to intensive care as the risk of infections is not neglectable [ 5 , 6 , 7 , 8 , 9 ]. Hence, a safe and efficient drug delivery platform technology for CNS active molecules is needed.…”

Best Practices for Intrathecal Baclofen Therapy: Troubleshooting

“…Therefore, premature emptying of the pump reservoir will not trigger the low reservoir alarm. There are rare reports of overinfusion, as manifested by symptoms of overdosing and a lower‐than‐expected reservoir residual volume . Similarly, an increase in reservoir residual volume may suggest an abnormality of the pump rotor or a severely kinked catheter, resulting in underdosing or withdrawal.…”