|
Model Number MCH-1000(M) |
Device Problem
Microbial Contamination of Device (2303)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/31/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
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 11/15/23.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.
|
|
Event Description
|
Cq technician notified cq service via airtable that the internal tubing of this device was identified as potentially contaminated during an on-site pm.The technician took pictures of the internal tubing of the device, which were to sent to cq for review.Cq director of operations and epidemiologist reviewed the pictures and 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.
|
|
Search Alerts/Recalls
|
|
|