CARDIOQUIP MODULAR COOLER HEATER
Received Aug 2, 2023 · Event occurred Jul 6, 2023
Report 3007899424-2023-00313 · MDR key 17441973
Device
Product problems
- Microbial Contamination of Device
- Microbial Contamination of Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional 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 07/06/23. AS OF THE DATE OF THIS REPORT, THERE HAS BEEN NO RESPONSE TO THE RECOMMENDATION.
Description of Event or Problem
UPON INSPECTION OF THE INTERNAL COMPONENTS/TANK, OUR TECHNICIAN IDENTIFIED POTENTIAL CONTAMINATION WITH THE UNIT. THE TECHNICIAN TOOK PICTURES OF THE INTERNAL TUBING OF THE DEVICE AND FORWARDED THEM TO CQ FOR REVIEW. BASED ON OUR FINDINGS, EPIDEMIOLOGY RECOMMENDS PERFORMING HETEROTROPHIC PLATE COUNT (HPC) TESTING ON THE IMPACTED UNIT(S) TO PROVIDE A QUANTITATIVE ASSESSMENT OF WATER QUALITY.
Additional Manufacturer Narrative
A CARDIOQUIP TECHNICIAN SUBMITTED PHOTOS OF TUBING TO EPIDEMIOLOGY FOR INVESTIGATION DURING AN ON-SITE INSPECTION. DUE TO THE DISCOLORATION OF THE TUBING, EPIDEMIOLOGY RECOMMENDED THAT THE DEVICE RECEIVE HPC TESTING TO PROVIDE A QUANTITATIVE ASSESSMENT OF WATER QUALITY. FOLLOWING TEST RESULTS OUTSIDE OF CARDIOQUIP SPECIFICATIONS, CARDIOQUIP RECOMMENDED THAT THE DEVICE RECEIVE AN INTERNAL WATER PATHWAY REPLACEMENT. THE CUSTOMER THEN SENT THE DEVICE TO CARDIOQUIP FOR REPAIR. THE DEVICE WAS RETURNED TO SPECIFICATION VIA AN INTERNAL WATER PATHWAY REPLACEMENT. FOLLOWING THE REPAIR, THE DEVICE PASSED INSPECTION AND IS FULLY FUNCTIONAL.
Description of Event or Problem
UPON INSPECTION OF THE INTERNAL COMPONENTS/TANK, OUR TECHNICIAN IDENTIFIED POTENTIAL CONTAMINATION WITH THE UNIT. THE TECHNICIAN TOOK PICTURES OF THE INTERNAL TUBING OF THE DEVICE AND FORWARDED THEM TO CQ FOR REVIEW. BASED ON OUR FINDINGS, EPIDEMIOLOGY RECOMMENDS PERFORMING HETEROTROPHIC PLATE COUNT (HPC) TESTING ON THE IMPACTED UNIT(S) TO PROVIDE A QUANTITATIVE ASSESSMENT OF WATER QUALITY.
Remedial action
- Inspection
- Repair