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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAR COR PURIFICATION MAR COR COMPLETE WATER TREATMENT SYSTEM SUBSYSTEM, WATER PURIFICATION

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MAR COR PURIFICATION MAR COR COMPLETE WATER TREATMENT SYSTEM SUBSYSTEM, WATER PURIFICATION Back to Search Results
Model Number PVC LOOP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chemical Exposure (2570); No Known Impact Or Consequence To Patient (2692)
Event Date 09/18/2016
Event Type  Injury  
Manufacturer Narrative
Mar cor (mcp) technician arrived on a sunday to perform a dialysis loop disinfect service. Notified nurses on-site prior to starting the disinfection and received permission to start the monthly disinfect. After the loop disinfection and during the dialysis loop rinse out, the mcp technician was performing a disinfectant residual check of all the patient rooms on the 6th floor. During this rise out/residual check it was discovered a dialysis technician had started a patient on dialysis. The dialysis machine was disconnected from the water loop and the water loop port tested positive for disinfectant. Rinse out of the water loop port was performed until the residual disinfectant check showed negative. The clinic staff was notified immediately of this incident. Mcp has spoken with the clinic and has not been notified of any patient injury or patient requiring medical attention.
 
Event Description
Potential of exposure of one dialysis patient to minncare. No patients were hospitalized.
 
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Brand NameMAR COR COMPLETE WATER TREATMENT SYSTEM
Type of DeviceSUBSYSTEM, WATER PURIFICATION
Manufacturer (Section D)
MAR COR PURIFICATION
14550 28th avenue north
minneapolis MN 55447
Manufacturer (Section G)
MAR COR PURIFICATION
14550 28th avenue north
minneapolis MN 55447
Manufacturer Contact
megan dickey
14550 28th avenue north
minneapolis, MN 55447
7635533300
MDR Report Key6034695
MDR Text Key57682069
Report Number3019131-2016-00001
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K945559
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 10/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPVC LOOP
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/17/2016 Patient Sequence Number: 1
Treatment
MINNCARE
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