Hemoflow™ 0500164ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840861100040), received between Dec 29, 2017 and Jan 16, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A HEMODIALYSIS (HD) NURSE REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED TWO MINUTES AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN INTERNAL BLOOD LEAK. THE LEAK WAS NOT VISUALLY OBSERVED. THE MACHINE, A FRESENIUS 4008S MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE NOT USED. THERE WERE BROKEN MEMBRANES NOTED INSIDE THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS UNKNOWN, AS THE CUSTOMER VISUALIZED THE RUPTURE OF MEMBRANES, HOWEVER THERE WAS NO LOSS OF EXTERNAL BLOOD, NOR WAS BLOOD OBSERVED INTERNALLY. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9596660 ↗
• MalfunctionDec 30, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED TEN SECONDS AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN INTERNAL BLOOD LEAK. THE LEAK WAS VISUALLY OBSERVED ON THE UPPER HEAD OF THE DIALYZER ON THE ARTERIAL SIDE. THE MACHINE, A FRESENIUS 4008S MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE NOT USED AS THE LEAK WAS VISUALLY OBSERVED ON THE UPPER HEAD OF THE DIALYZER ON THE ARTERIAL SIDE. THERE WERE BROKEN MEMBRANES OBSERVED NEAR THE UPPER HEAD CAP OF THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS NOT QUANTIFIABLE AS IT WAS NOT POSSIBLE TO RETURN THE EXTRACORPOREAL CIRCUIT IN ITS ENTIRETY. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE DISCARDED AND NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9532504 ↗
• MalfunctionDec 17, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY CLINICAL MANAGER REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED ONE MINUTE AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN INTERNAL BLOOD LEAK. THE LEAK WAS VISUALLY OBSERVED IN THE BODY OF THE DIALYZER. THE NURSING STAFF NOTED SOME BROKEN MEMBRANES IN THE DIALYZER. THE MACHINE, A FRESENIUS 4008S MACHINE, ALARMED APPROPRIATELY WITH A BLOOD LEAK ALARM. BLOOD LEAK TEST STRIPS WERE NOT USED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 3 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9483199 ↗
• MalfunctionSep 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY NURSE REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED ONE HOUR AND FOUR MINUTES INTO THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT TREATMENT WAS RESTARTED WITH NEW SUPPLIES. THE FRESENIUS 4008 MACHINE DID NOT ALARM. FRESENIUS BLOODLINES WERE USED DURING TREATMENT. BLOOD STRIPS WERE NOT USED. THE BLOOD LEAK WAS NOTED AS INTERNAL. THERE WAS NO DEFECT OR DAMAGE SEEN ON THE DIALYZER. THE PATIENT¿S ESTIMATED BLOOD LOSS WAS APPROXIMATELY 5 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE DIALYZER WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9069960 ↗
• MalfunctionAug 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A CLINIC NURSE AT A USER FACILITY REPORTED THAT A DIALYZER LEAKED FROM THE MEMBRANES DURING PRETREATMENT SETUP OF A PATIENT¿S HEMODIALYSIS TREATMENT. A NEW DIALYZER WAS USED TO COMPLETE THE TREATMENT. UPON FOLLOW UP, IT WAS CONFIRMED THAT THERE WAS NO BLOOD LEAK. THERE WAS NO PATIENT INVOLVEMENT. THE PATIENT WAS TREATMENT COMPLETED SUCCESSFULLY ON THE SAME MACHINE WITH NEW SUPPLIES. THE DIALYZER WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 8905330 ↗
• MalfunctionMay 24, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED IMMEDIATELY AFTER THE INITIATION OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THERE WERE NO ALARMS FROM THE FRESENIUS 2008K HEMODIALYSIS MACHINE USED FOR TREATMENT, AS THIS WAS AN EXTERNAL BLOOD LEAK THAT WAS VISUALLY OBSERVED LEAKING FROM THE DIALYZER HEADER CAP. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 3ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH A NEW DIALYZER. THE COMPLAINT DEVICE WAS REPORTEDLY DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8639952 ↗
• MalfunctionDec 29, 2017Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY ADMINISTRATOR REPORTED EXPERIENCING PROBLEMS WITH A DIALYZER DURING HEMODIALYSIS TREATMENT, AND STATED THE MEMBRANES OF THE DIALYZER WERE BREAKING UPON USE AND THAT THE FILTER WAS BEING REJECTED BY THE SYSTEM DUE TO PRESSURE FAILURE. BLOOD LOSS WAS ALSO REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND WAS NOT RECEIVED TO DATE.

  Patient problems: Blood Loss

  MAUDE report 7154605 ↗