DSU-H Quick Connect 70-0285Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00896241002343), received between Dec 13, 2017 and Jun 6, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2022Filtration Problem; Filtration Problem

  ON (B)(6) 2022 IT WAS REPORTED THAT A HEALTHCARE FACILITY RECEIVED A POSITIVE CULTURE DOWNSTREAM OF A DSU-H (70-0285) IN ONE OF THEIR ICE MACHINES. THERE WERE NO REPORTED ADVERSE EVENTS. NEPHROS DSU-H IS AN IN-LINE WATER FILTER, CLASS II MEDICAL DEVICE THAT IS PLACED BEFORE ICE MACHINES IN HEALTH CARE FACILITIES IN ORDER TO RETAIN BACTERIA, VIRUS AND ENDOTOXIN. THE USER FACILITY ROUTINELY TEST THEIR WATER AT THEIR ICE MACHINE AND FOUND THAT THERE WAS POSITIVE BACTERIA DETECTED. A POSITIVE CULTURE CAN BE CAUSED BY AN IMPROPER DISINFECTION OF THE ICE MACHINE OR WATER LINES LEADING TO THE ICE MACHINE, AND/OR A BREACH OF THE FILTER MEMBRANE. THE ROOT CAUSE OF THE POSITIVE CULTURE COULD NOT BE CONFIRMED AS THE FILTER WAS NOT RETURNED FOR ADDITIONAL INVESTIGATION. COMPREHENSIVE REVIEW OF THE SPECIFIC FILTER DEVICE HISTORY RECORD AND MANUFACTURING INSPECTIONS DID NOT IDENTIFY ANY PRODUCT ISSUES. ADDITIONAL INFORMATION INCLUDING CULTURE RESULTS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL/FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14606025 ↗
• MalfunctionJun 6, 2022Filtration Problem; Filtration Problem

  ON (B)(6) 2022 IT WAS REPORTED THAT A HEALTHCARE FACILITY RECEIVED A POSITIVE CULTURE DOWNSTREAM OF A DSU-H (70-0285) IN ONE OF THEIR ICE MACHINES. THERE WERE NO REPORTED ADVERSE EVENTS. NEPHROS DSU-H IS AN IN-LINE WATER FILTER, CLASS II MEDICAL DEVICE THAT IS PLACED BEFORE ICE MACHINES IN HEALTH CARE FACILITIES IN ORDER TO RETAIN BACTERIA, VIRUS AND ENDOTOXIN. THE USER FACILITY ROUTINELY TEST THEIR WATER AT THEIR ICE MACHINE AND FOUND THAT THERE WAS POSITIVE BACTERIA DETECTED. A POSITIVE CULTURE CAN BE CAUSED BY AN IMPROPER DISINFECTION OF THE ICE MACHINE OR WATER LINES LEADING TO THE ICE MACHINE, AND/OR A BREACH OF THE FILTER MEMBRANE. THE ROOT CAUSE OF THE POSITIVE CULTURE COULD NOT BE CONFIRMED AS THE FILTER WAS NOT RETURNED FOR ADDITIONAL INVESTIGATION. COMPREHENSIVE REVIEW OF THE SPECIFIC FILTER DEVICE HISTORY RECORD AND MANUFACTURING INSPECTIONS DID NOT IDENTIFY ANY PRODUCT ISSUES. ADDITIONAL INFORMATION INCLUDING CULTURE RESULTS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL/FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14601899 ↗
• MalfunctionApr 4, 2018Break; Break

  ON (B)(6) 2018 IT WAS REPORTED THAT A HEALTHCARE FACILITY RECEIVED A POSITIVE CULTURE DOWNSTREAM OF A DSU-H (70-0285) IN ONE OF THEIR ICE MACHINES.THERE WAS NO REPORTED ADVERSE EVENTS OR HEALTH ISSUES CONNECTED WITH THE POSITIVE RESULT. NEPHROS DSU-H IS AN IN-LINE WATER FILTER, CLASS II MEDICAL DEVICE THAT IS PLACED BEFORE ICE MACHINES IN HEALTH CARE FACILITIES IN ORDER TO RETAIN BACTERIA, VIRUS AND ENDOTOXIN. THE USER FACILITY ROUTINELY TEST THEIR WATER AT THEIR ICE MACHINE AND FOUND THAT THERE WAS POSITIVE BACTERIA DETECTED. FROM THE INITIAL DISCUSSION, IT IS LIKELY THAT OUR DISINFECTION AND INSTALLATION PROCEDURES WERE NOT FOLLOWED.

  Patient problems: No Patient Involvement

  MAUDE report 7397667 ↗
• MalfunctionDec 13, 2017Break; Material Integrity Problem; Break; Material Integrity Problem

  NEPHROS RECEIVED A REPORT FROM A USER FACILITY ADVISING US THAT ONE OF THEIR ICE MACHINES TESTED POSITIVE WITH AN UNSPECIFIED SPECIES OF BACTERIA. THERE WERE NO REPORTED ADVERSE EVENTS OR HEALTH ISSUES CONNECTED WITH THE POSITIVE RESULT. NEPHROS DSU-H IS AN IN-LINE WATER FILTER, CLASS II MEDICAL DEVICE THAT IS PLACED BEFORE ICE MACHINES IN HEALTH CARE FACILITIES IN ORDER TO RETAIN BACTERIA, VIRUS AND ENDOTOXIN. THE USER FACILITY ROUTINELY TESTS THEIR WATER AT THE ICE MACHINE AND FOUND THAT THERE WAS POSITIVE BACTERIA DETECTED.

  Patient problems: No Patient Involvement

  MAUDE report 7112518 ↗