PERFUSION REPORTS

REPORT

145

DATE

6/8/2026

TITLE

Disposables: Faulty cardioplegia cannula

DETAILS OF INCIDENT

We have identified a defect with a cardioplegia aortic root cannula. The connector component appears to have separated from the cannula assembly. The affected cannula was identified during use, held together by the surgical team during cardioplegia delivery and retained in case it is required for investigation or return.

DETAILS OF INJURY TO PATIENT

No harm to patient

TYPE OF DEVICE/MANUFACTURER

Ga Cardioplegia Cannula REF: AR-11112 LOT: 2607600045 Size: 9 Fr. LOT/Batch number 2607600045, date of manufacture 2026-03-17, expiry date 2029-03-16.

ACTION TAKEN

The cannula was held together by the surgical team during cardioplegia delivery as it did not seem appropriate to replace at the time by the surgical team. The manufacturer has been contacted and informed of this incident. The cardioplegia cannula was retained to send back to manufacturer's upon their request.

RESPONSE FROM MANUFACTURER

ADDTIONAL INFORMATION

The connector component separated from the cannula assembly during use. The cannula remained functional only because the surgical team manually maintained the connection during cardioplegia delivery.

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