Bayer—Source Administration Sets Used with Medrad Intego PET Infusion Systems: Saline Tubing May Be Out of Specification; Radio Pharmaceutical Tubing May Be Occluded by Solvent

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In a November 30, 2015, Urgent Medical Device Field Corrective Action letter submitted by an ECRI Institute member hospital, Bayer states that the inner diameter of the saline tubing of the administration sets listed below may be out of specification, potentially resulting in the system failing to position the dose correctly during extraction and possibly leading to a low measurement of the extracted dose or to a higher dose being extracted. Bayer also states that the occluded SAS tubing may impair the priming function and prompt an "RP radio pharmaceutical prime failed. Check SAS and vial installation, then reprime" error message. These problems may result in inaccurate dose reporting in the patient record. Bayer further states that it has received no reports of patient or user injury as a result of this problem. The manufacturer has not confirmed the...