MAUDE Adverse Event Report: AMERIWATER AMERIWATER (PENTAIR); MROS PORTABLE REVERSE OSMOSIS SYSTEM (PENTEK CHLORPLUS 20 FILTER)

Model Number	MROS
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: AMERIWATER (PENTAIR)
• Common Device Name: MROS PORTABLE REVERSE OSMOSIS SYSTEM (PENTEK CHLORPLUS 20 FILTER)
• Manufacturer (Section D): AMERIWATER; 3345 stop 8 road; dayton OH 45414
• Manufacturer (Section G): AMERIWATER; 3345 stop 8 rd; suite a; dayton OH 45414
• Manufacturer Contact: brian bowman ; 3345 stop 8 rd; suite a; dayton, OH 45414 ; 9374618833
• MDR Report Key: 21379303
• Report Number: 1530185-2025-00001
• Device Sequence Number: 21019404
• Product Code: FIP
• UDI-Device Identifier: 00817927020000
• UDI-Public: 00817927020000
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K111740
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MROS
• Device Catalogue Number: 00MROS20
• Device Lot Number: 095432506 (MULTIPLE SEE B7)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown