Bayer Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System 의 리콜

Recall

RC-2015-RN-01195-1

Class II

2015-12-07

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01195-1

Bayer medical care inc. has identified that certain batches of the source administration sets (sas) used with the medrad intego pet infusion system may contain out-of-specification saline tubing and/or solvent occluding the radio pharmaceutical (rp) tubing.The inner diameter of the saline tubing is out-of-specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. the occluded sas tubing may impair the priming function and prompt an “rp prime failed. check sas and vial installation, then reprime.” error message. although unlikely, these situations may lead to procedure delay, false negative result due to incomplete dose, inaccurate dose reporting in the patient record, overdose of rp delivered and in rare situations additional radiation exposure for the operator.

The sponsor Imaxeon is advising the users to inspect stock and quarantine the affected units prior to their return to the sponsor. There may be a delay in replacing the affected stock due to limited new inventory. This action has been clsoed-out on 29/08/2016.