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

Device Problems Device Emits Odor (1425); Filtration Problem (2941)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/14/2014

Event Type  No Answer Provided  

Event Description

Facility personnel observed a strong smell of sulfur coming from the mcp central water platform's filtration carbon media.Patient treatment was delayed.

Manufacturer Narrative

Customer notified mar cor (mcp) that the carbon bedding in their water purification system smelt strongly of sulfur.The odor permeated the entire clinic and patient treatment was delayed.After investigation, the root cause was determined to be that the customer did not do the required disinfection prior to rebedding the tanks as per mcp manual me 12565 (automatic carbon tank).Proper procedure for disinfecting the machine were not being followed and the carbon bedding should be replaced.To date, there were no reports of patient injury or other adverse patient impact; however, dialysis treatment was delayed.This complaint will continue to be monitored within mcp complaint system.

• Brand Name: MAR COR COMPLETE WATER TREATMENT SYSTEM
• Type of Device: WATER PURIFICATION SYSTEM
• Manufacturer (Section D): MAR COR PURIFICATION; 14550 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MAR COR PURIFICATION; 14550 28th ave n; minneapolis MN 55447
• Manufacturer Contact: megan dickey ; 14550 28th ave n; minneapolis, MN 55447 ; 7635533300
• MDR Report Key: 3793897
• MDR Text Key: 17611226
• Report Number: 3019131-2014-00019
• 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: User Facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1