Photos of tubing were submitted by a cardioquip technician and sent to cardioquip epidemiology for investigation during an onsite service visit.Due to the discoloration of the tubing, epidemiology recommended that the device receive hpc testing to provide a quantitative assessment of the water quality.The customer was notified of the potential contamination and recommendation via email on 11/02/23.As of the date of this report, there has been no response to the recommendation.A follow-up will be filed if any additional information or information that corrects this report is obtained.
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Cq technician notified cq service via airtable that the internal tubing of this device was suspect of bacterial contamination during an on-site pm.The technician took pictures of the tubing, which were reviewed by cq director of operations and epidemiologist, who recommended that the device receive hpc testing to gain a quantitative analysis of water quality.This issue was identified on 11/01/2023, no patient involvement was reported.
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