BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERIWATER (PENTAIR)

    MDR report key: 21379303 · Received February 13, 2025

    Report

    Report Number
    1530185-2025-00001
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    January 13, 2025
    Report Date
    February 12, 2025
    Manufacturer
    AMERIWATER
    Product Code
    FIP
    UDI-DI
    00817927020000
    PMA / PMN Number
    K111740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PENTAIR CHLORPLUS 20 FILTER CARTRIDGES USED AS PRETREATMENT FOR THE REMOVAL OF CHLORINE AND CHLORMANINES IN WATER FEEDING THE AMERIWATER MROS PORTABLE REVERSE OSMOSIS SYSTEM AND THE AMERIWATER CENTURION PORTABLE REVERSE OSMOSIS SYSTEM EXHIBITED PREMATURE TOTAL CHLORINE BREAKTHROUGH AT THE PRIMARY CARBON FILTER IN A TOTAL OF 7 LOTS SUPPLIED TO AMERIWATER LLC BY PENTAIR. NO ADVERSE EVENTS, ILLNESSES, OR INJURIES. 02/11/2025, PENTAIR ISOLATED THE NONCONFORMANCE TO LOTS OF FILTERS PRODUCED WITH CARBON SUPPLIED BY AN ALTERNATE SUPPLIER. ALL NONCONFORMING LOTS HAVE BEEN QUARANTINED AND PENTAIR HAS RESUMED ASSEMBLY WITH CARBON FROM THEIR PRIMARY SUPPLIER WITH KNOWN GOOD QUALITY. PURCHASES OF CARBON FROM THE ALTERNATE SUPPLIER HAVE BEEN SUSPENDED.

    Description of Event or Problem · 0

    AMERIWATER IS SELF-REPORTING AN ISSUE EXPERIENCED WITH THE PENTAIR CHLROPLUS20 CARBON BLOCK FILTER USED AS PRETREATMENT FOR THE AMERIWATER MODEL MROS AND AMERIWATER CENTURION, MODEL MROC. ON (B)(6) 2025, AMERIWATER RECEIVED NOTICE FROM A LOCAL CUSTOMER THAT THE CARBON BLOCK FILTERS (AMERIWATER PART NUMBER: 20-5012) USED IN THE AMERIWATER MODEL MROS PORTABLE REVERSE OSMOSIS SYSTEM WERE EXPERIENCING PREMATURE CHLORINE BREAKTHROUGH. NO ADVERSE EVENTS, INJURY, ILLNESS, OR PATIENT EXPOSURE WAS REPORTED. THE PREMATURE CHLORINE BREAKTHROUGH WAS BELIEVED TO BE THE RESULT OF WATER CONDITIONS AT THE FACILITY. AMERIWATER REPLACED THE FILTERS AND RETURNED THE ALLEGEDLY NONCONFORMING FILTER CARTRIDGES TO OUR FACILITY FOR TESTING. CHLORINE BREAKTHROUGH WAS EXPERIENCED AFTER LESS THAN A WEEK OF USE, WHEN THE FILTER CAPACITY NORMALLY LASTED LONGER THAN 1 MONTH. ON (B)(6) 2025 AMERIWATER REPLACED THE NONCONFORMING FILTERS WITH FILTERS FROM A KNOWN GOOD LOT. 16-JAN-2025, A SECOND REPORT WAS RECEIVED FROM AN END USER IN (B)(6). NO ADVERSE EVENTS, INJURY, ILLNESS, OR PATIENT EXPOSURE WAS REPORTED. AMERIWATER HALTED SHIPMENT OF THE 20-5012 FILTERS, QUARANTINED THE FILTERS, AND BEGAN TESTING SAMPLES FROM EACH LOT IN OUR INVENTORY (TOTAL OF 12 DIFFERENT LOT NUMBERS IN INVENTORY). BY END OF DAY 17-JAN-2025, 4 OF THE 12 LOTS HAD BEEN IDENTIFIED AS POTENTIALLY NONCONFORMING. FILTERS FROM LOTS THAT WERE CONFIRMED GOOD WERE PLACED BACK INTO INVENTORY FOR USE IN ORDER FULFILLMENT. REPLACEMENT FILTERS FROM A KNOWN GOOD LOT WERE SHIPPED TO THE END USER IN (B)(6). 20-JAN-2025, AMERIWATER GENERATED A NONCONFORMANCE REPORT AND RETURNED 4 NONCONFORMING 20-5012 FILTER CARTRIDGES TO PENTAIR FOR EVALUATION WITH A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR). AMERIWATER DETERMINED THAT REPLACEMENT FILTERS SHOULD BE SENT TO CUSTOMERS THAT RECEIVED FILTERS FROM POTENTIALLY NONCONFORMING LOTS TO ENSURE THAT THEY ARE PREPARED SHOULD THEY EXPERIENCE PREMATURE CHLORINE BREAKTHROUGH. 24-JAN-2025, AMERIWATER CONCLUDED TESTING OF ALL 12 LOTS IN INVENTORY WITH 7 OF THE 12 LOTS PRODUCING QUESTIONABLE RESULTS. AMERIWATER NOTIFIED PENTAIR OF THE RESULTS. PENTAIR SENT AN EMAIL TO AMERIWATER CONFIRMING THAT THEIR TESTING ALSO CONFIRMED THAT THE RETURNED FILTER CARTRIDGES DID NOT PERFORM TO PENTAIR'S DESIGN EXPECTATIONS FOR REDUCING CHLORINE IN THE WATER. 27-JAN-2025, AMERIWATER GENERATED A LIST OF CUSTOMERS THAT RECEIVED THE POTENTIALLY NONCONFORMING LOTS OF FILTERS, BOTH WITH NEW MROS OR CENTURION SYSTEMS, OR AS CONSUMABLE REPLACEMENTS, AND RECEIVED REPLACEMENT FILTERS FROM PENTAIR (FROM KNOWN GOOD LOTS). 28-JAN-2025, RETURNED THE BALANCE OF SUSPECT LOTS FROM AMERIWATER'S INVENTORY TO PENTAIR. ON (B)(6) 2025, AMERIWATER CONTACTED CUSTOMERS THAT RECEIVED FILTERS FROM POTENTIALLY NONCONFORMING LOTS TO INFORM THEM THAT AMERIWATER WAS PROACTIVELY SENDING REPLACEMENT FILTERS IN CASE PREMATURE CHLORINE BREAKTHROUGH WAS EXPERIENCED. 31-JAN-2025, REPLACEMENT FILTERS WERE SHIPPED TO ALL CUSTOMERS IDENTIFIED AS HAVING FILTERS FROM POTENTIALLY NONCONFORMING LOTS. THERE WERE NO ADVERSE EVENTS, INJURY, OR ILLNESS REPORTED, AND NO PATIENT INVOLVEMENT. NO FURTHER REPORTS OF PREMATURE CHLORINE BREAKTHROUGH HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168412 AMERIWATER (PENTAIR) MROS PORTABLE REVERSE OSMOSIS SYSTEM (PENTEK CHLORPLUS 20 FILTER) FIP AMERIWATER MROS 095432506 (MULTIPLE SEE B7) 00817927020000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other