2008® Series Hemodialysis Machines 190630Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840861100866), received between Jul 25, 2017 and Apr 7, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

1 FDA recall record name this device's identifier.

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 18, 2026.

Recalls naming this device

1. Dec 14, 2017Class IITerminated

   When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.

   Z-1278-2018 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO FRESENIUS THAT THE BLOOD PUMP ON A 2008K2 MACHINE MADE AN INCISION IN THE TUBING OF THE BLOODLINES DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT RESULTING IN BLOOD LOSS. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE PATIENT WAS APPROXIMATELY 2 HOURS INTO TREATMENT WHEN THE MACHINE ALARMED WITH AN AIR DETECTION MESSAGE. THE REGISTERED NURSE (RN) REMOVED AIR FROM THE VENOUS CHAMBER OF THE BLOODLINES TO CONTINUE TREATMENT BUT THE MESSAGE REOCCURRED. BLOOD WAS VISUALLY OBSERVED TO BE DRIPPING. UPON INSPECTION AN INCISION WAS IDENTIFIED IN THE TUBING OF THE BLOODLINES LOCATED NEAR THE BLOOD PUMP. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) COULD NOT BE PROVIDED. THE PATIENT WAS ABLE TO COMPLETE TREATMENT ON A DIFFERENT MACHINE WITH NEW SUPPLIES (MANUFACTURER UNKNOWN). THE MACHINE WAS REMOVED FROM SERVICE FOLLOWING THE EVENT AND A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ON SITE. THE FST DETERMINED THE ROTORS OF THE BLOOD PUMP WERE WORN AND BENT. THE BLOOD PUMP WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE MACHINE HAS BEEN RETURNED T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702819 ↗
• MalfunctionApr 6, 2023Material Split, Cut or Torn; Air/Gas in Device

  THE PATIENTS MACHINE ALARMED. REGISTERED NURSE (RN) GOT THE AIR OUT OF THE VENOUS CHAMBER AND TREATMENT WAS CONTINUED. THE MACHINE ALARMED AGAIN, FOR THE AIR DETECTOR. LINES WERE OBSERVED AND A SMALL INCISION IN THE TUBING AROUND THE BLOOD PUMP WAS NOTED. THE MACHINE WAS SWITCHED OUT AND AN ENTIRE NEW SYSTEM WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16688852 ↗
• InjurySep 29, 2017Calibration Problem; Adverse Event Without Identified Device or Use Problem; Pumping Problem; Calibration Problem; Adverse Event Without Identified Device or Use Problem; Pumping Problem

  A FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES) WAS CALLED ONSITE TO REPAIR A 2008K HEMODIALYSIS (HD) MACHINE WITH ULTRAFILTRATION (UF) PUMP OUT OF SPECIFICATION. IT WAS REPORTED A HEMODIALYSIS (HD) PATIENT CODED WHILE RECEIVING TREATMENT ON THE MACHINE. THE RES RECALIBRATED THE UF PUMP TO RESOLVE THE ISSUE. THE MACHINE WAS RETURNED TO SERVICE. FOLLOW-UP WAS MADE WITH THE FACILITY REGISTERED NURSE (RN), WHO STATED SHE WAS UNWILLING TO DISCLOSE ANY PATIENT INFORMATION DUE TO PATIENT PRIVACY/CONFIDENTIALITY. THE RN STATED THE MACHINE DID NOT HAVE ANY ISSUES DURING SET-UP AND THAT THE MACHINE DID NOT ALARM AT THE TIME THE PATIENT EXPIRED. THE RN STATED THE FACILITY USED FRESENIUS DIALYZERS, BLOODLINES, ACID CONCENTRATE AND BICARB CONCENTRATE DELIVERED VIA JUGS. THE CATALOG AND LOT NUMBERS OF THE FRESENIUS PRODUCTS WERE UNKNOWN. NO SAMPLES WERE OBTAINED TO BE RETURNED FOR EVALUATION. ALTHOUGH REQUESTED, NO FURTHER PATIENT SPECIFIC OR EVENT RELATED DETAILS WERE MADE AVAILABLE.

  Patient problems: Cardiac Arrest; Myocardial Infarction

  MAUDE report 6905033 ↗
• MalfunctionSep 29, 2017Programming Issue; Programming Issue

  IT WAS REPORTED BY A CLINICAL SERVICE SPECIALIST THAT THE AFTER THE TREATMENT PARAMETERS WERE ENTERED, THE ULTRAFILTRATION (UF) RATE CHANGED TO 300 ML/HR AND THE UF TIME CHANGED 3 HOURS. THE CLINICAL STAFF NOTICED THIS AS IT HAPPENED AND CORRECTED IT. THE PATIENT COMPLETED TREATMENT ON THE MACHINE WITHOUT ANY ILL EFFECTS OR ADVERSE EVENTS. FOLLOW-UP WAS MADE WITH THE CLINIC BIOMEDICAL ENGINEER, WHO STATED THE ISSUE OCCURRED WHEN THE MACHINE WAS INITIALLY IN TREATMENT MODE AND CONFIRMED THERE WAS NO PATIENT INJURY AND NO ADVERSE EVENT OCCURRED. PER BIOMED TECH THE PATIENT INFORMATION AND MACHINE SERIAL NUMBER WERE UNKNOWN. THE BIOMED TECH STATED THE ISSUE WAS RESOLVED BY HAVING THE MACHINE TURNED OFF AND TURNED BACK ON. THE BIOMED TECH STATED NO COMPONENTS OR REPAIRS WERE NEEDED, AND THE MACHINE REMAINED IN USE WITHOUT FURTHER ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6904702 ↗
• MalfunctionSep 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION IN THE COMPLAINT FILE WAS REVIEWED BY A POST MARKET SURVEILLANCE CLINICIAN. ON (B)(6) 2017, A FACILITY BIOMEDICAL ENGINEER CONTACTED TECHNICAL SUPPORT TO STATE THAT ONE OF THE HEMODIALYSIS (HD) MACHINES WAS BEING REJECTED BY THE HD NURSE DUE TO A PATIENT HAVING EXPIRED WHILE PERFORMING HD TREATMENT ON THAT MACHINE. DURING A FOLLOW UP CALL TO THE HD NURSE ON (B)(6) 2017, IT WAS DOCUMENTED THAT THIS UNIDENTIFIED PATIENT DID EXPIRE ON (B)(6) 2017 (UNKNOWN CAUSE) DURING HD TREATMENT, BUT THAT THE NURSE DID NOT WANT TO PROVIDE ANY PATIENT INFORMATION DUE TO PRIVACY AND CONFIDENTIALITY. THE NURSE DID STATE THAT THERE WAS NO ISSUE WITH THE MACHINE DURING SET-UP AND THERE WERE NO ALARMS. THE PATIENT EXPIRED WHILE CONNECTED TO THE MACHINE. THE EVENTS SURROUNDING THE DEATH ARE UNKNOWN AND IT IS UNKNOWN IF ANY LIFE SUSTAINING MEASURES WERE TAKEN. THE HD NURSE ALSO STATED THAT NO MACHINE REPAIRS WERE NEEDED AND THE MACHINE WAS PLACED BACK IN SERVICE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Death

  MAUDE report 6903718 ↗
• MalfunctionJul 25, 2017Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL ENGINEER (BIOMED) AT A USER FACILITY REPORTED THAT THE FRESENIUS 2008K2 HEMODIALYSIS (HD) MACHINE HAD OBSERVED CONNECTION IC26 ON THE ACTUATOR-TEST BOARD BURNING UP WHEN THE MACHINE POWERS ON. THE BIOMED FOUND SIGNS OF BURN DAMAGE ON THE ACTUATOR-TEST BOARD AT CONNECTION IC26. THERE WAS A BUBBLE ON THE TOP OF THE CONNECTION OF THE TWO LEGS AND ALSO BURN DAMAGE ON THE SIDE OF THE CONNECTION. FOLLOW-UP INFORMATION WITH THE BIOMED REVEALED THAT THE STAFF HAD REPORTED TO HAVE OBSERVED A FAINT BURN SMELL WHEN THE MACHINE WAS POWERED ON. THERE WAS NO SMOKE, FLAME, OR SPARK OBSERVED. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS MALFUNCTION. THE BIOMED REPLACED THE DEAERATION MOTOR AND THE ACTUATOR-TEST BOARD. FOLLOWING THE PART REPLACEMENT, THE SYSTEM WAS RESTORED TO FULL FUNCTIONALITY. THE UNIT IS REPORTED TO BE READY TO BE RETURNED TO SERVICE AT THE USER FACILITY WHEN NEEDED. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6740882 ↗