PERFUSION REPORTS

REPORT
043
DATE
1/7/2019
TITLE
Getinge Mal-Position Of IABP Catheter
DETAILS OF INCIDENT

A mal-positioned Intra-Aortic Balloon catheter was punctured by the surgeon's blade when preparing for aortic cannulation and cardiopulmonary bypass. The puncture hole in the catheter was of 5-8mm in length and allowed the full Helium contents of the balloon itself to be purged into the ascending aorta of the patient.

DETAILS OF INJURY TO PATIENT

On reducing sedation on Intensive Care, the patient developed a seizure. A CT of the head revealed extensive cerebral infarcts consistent with helium embolization. Unfortunately, the patient did not recover neurologically and sadly passed away six days post-op.

TYPE OF DEVICE/MANUFACTURER

Maquet/Getinge

Size And Type: 7.5 Linear

ACTION TAKEN

Review of all Trust IAB Policies with a particular focus on insertion and removal guidelines; Review of Gas Embolism guidelines to ensure they are current; formalise IAB training across surgical team; perform MDT scenario training; Getinge have interrogated their own product complaints/reports and determined that the relevant Lot Numbered product was not involved any similar reports.

MHRA - Informed

NPSA - informed

Local Risk Group - Informed

RESPONSE FROM MANUFACTURER
ADDTIONAL INFORMATION
SUPPORTING VISUALS/VIDEO
SUPPORTING DOCUMENT

OTHER PERFUSION
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