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

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.

• Brand Name: MAR COR COMPLETE WATER TREATMENT SYSTEM
• Type of Device: SUBSYSTEM, 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 Key: 6034695
• MDR Text Key: 57682069
• Report Number: 3019131-2016-00001
• Device Sequence Number: 1
• Product Code: FIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• 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 Received: 10/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PVC LOOP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/18/2016
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: MINNCARE
• Patient Outcome(s): Other