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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO C STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. AMSCO C STERILIZER Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/03/2021
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found the view port had been damaged allowing water and steam to leak from the sterilizer.The technician replaced the viewport, tested the unit, confirmed it to be operating according to specifications, and returned it to service.No additional issues have been reported.
 
Event Description
The user facility reported water and steam leaking from their amsco c sterilizer.No report of injury.
 
Manufacturer Narrative
A steris service technician collected water samples to be tested.The results identified that one of the critical chemical attributes of water quality was above the maximum requirements as stated in the amsco c sterilizer operator manual (table 7-3.Required feed water quality for carbon steel steam generators).The user facility is responsible for ensuring that their incoming water supply remains within the electric steam generator's operating requirements.The amsco c sterilizer operator manual states (3-1), "water quality - supplied must be within specifications.Improper water quality adversely affects equipment operation." the technician notified the customer of the water quality test results and that their water quality is not meeting the required operating conditions.The user facility has committed to making the necessary improvements to the facility's incoming water quality.No additional issues have been reported.
 
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Brand Name
AMSCO C STERILIZER
Type of Device
STERILIZER
Manufacturer (Section D)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, 67190
MX  67190
MDR Report Key11898061
MDR Text Key256230631
Report Number3005899764-2021-00026
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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