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

PERFUSION REPORTS

OTHER PERFUSION
REPORTS

SCPS

CCPS

PERFUSION REPORTS

OTHER PERFUSION REPORTS

SCPS

CCPS

OTHER PERFUSION
REPORTS