NaturaLyteRecalls & reported problems across all models
Fresenius Medical Care Holdings, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 25
- Deaths reported
- 2
- Injuries reported
- 23
- Recalls
- 1
We found 2 models of NaturaLyte by Fresenius Medical Care Holdings, Inc. in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Jun 26, 2017 and Jul 19, 2019 — classified as 2 deaths, 23 injuries.
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
NaturaLyte recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 28, 2021Class IITerminated
Exposed to freezing temperatures due to refrigerated truck malfunctions
Z-2087-2021 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported NaturaLyte problems
Device problems
- Adverse Event Without Identified Device or Use Problem25
Patient problems
- Hemolysis14
- Cardiac Arrest3
- Nausea3
- Cramp(s)2
- Death2
- Low Blood Pressure/ Hypotension2
- Vomiting2
- Loss of consciousness1
NaturaLyte models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NaturaLyte 08-4112-2DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)1 recall1 death24 reports
- NaturaLyte 08-4000-LB 6.4LDIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)1 death1 report
Recent NaturaLyte adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT¿S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 9.0 TO 6.7. THE PATIENT REQUIRED A BLOOD TRANSFUSION ON (B)(6) 2019; HOWEVER, THEY WERE NOT ADMITTED TO THE HOSPITAL. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS 160 DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2.5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH ANY OF THE FRESENIUS PRODUCTS USED, AS WELL AS NO MACHINE ALARMS, CLOTTING EVENTS AND/OR DIALYZER LEAKS IN RELATION TO THE HEMOLYSIS EVENT. IT WAS REPORTED THERE WAS NOTHING UNUSUAL IN ANY OF THE HEMODIALYSIS TREATMENTS. THERE WERE NO VIS
Patient problems: Hemolysis
MAUDE report 8808478 ↗InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT¿S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 12.8 TO 11.2. THE PATIENT REQUIRED A BLOOD TRANSFUSION ON (B)(6) 2019 OUTPATIENT DUE TO AN UNKNOWN SURGICAL PROCEDURE; HOWEVER, THEY WERE NOT ADMITTED TO THE HOSPITAL. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2.5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH ANY OF THE FRESENIUS PRODUCTS USED, AS WELL AS NO MACHINE ALARMS, CLOTTING EVENTS AND/OR DIALYZER LEAKS IN RELATION TO THE HEMOLYSIS EVENT. IT WAS REPORTED THERE WAS NOTHING UNUSUAL IN ANY OF
Patient problems: Hemolysis
MAUDE report 8808204 ↗InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT¿S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 10.6 TO 8.4. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2019 WITH A HEMOGLOBIN OF 6.7 AND REQUIRED A BLOOD TRANSFUSION. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. FURTHER DETAILS REGARDING THE PATIENT¿S HOSPITALIZATION ARE CURRENTLY UNKNOWN. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2.5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH ANY OF THE FRESENIUS PRODUCTS USED, AS
Patient problems: Hemolysis
MAUDE report 8807855 ↗InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT¿S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 12.5 TO 11.1. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2019 WITH A HEMOGLOBIN OF 8.6 AND REQUIRED A BLOOD TRANSFUSION. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. FURTHER DETAILS REGARDING THE PATIENT¿S HOSPITALIZATION ARE CURRENTLY UNKNOWN. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2.5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH ANY OF THE FRESENIUS PRODUCTS USED, A
Patient problems: Hemolysis
MAUDE report 8807225 ↗InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT WAS NOT DIALYZING IN THE CLINIC ON (B)(6) 2019 AND (B)(6) 2019 BECAUSE THE PATIENT WAS IN THE HOSPITAL DUE TO A PLANNED LOWER EXTREMITY AMPUTATION (NOT RELATED TO HEMODIALYSIS OR ANY FRESENIUS PRODUCTS). THE PATIENT¿S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. THE PATIENT¿S HEMOGLOBIN WAS 10.2 ON (B)(6) 2019. THE PATIENT WAS REPORTED DIALYZING ON (B)(6) 2019 AND (B)(6) 2019 WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS 180 DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2.5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN TO 8.8. THE PATIENT REQUIRED A BLOOD TRANSFUSION ON (B)(6) 2019; HOWEVER, THEY WERE NOT ADMITTED TO THE HOSPITAL. THE PATIENT¿S HEMOGLOBI
Patient problems: Hemolysis
MAUDE report 8806776 ↗InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT¿S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 12 TO 9.6. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2019 WITH A HEMOGLOBIN OF 7.7 AND REQUIRED A BLOOD TRANSFUSION. FURTHER DETAILS REGARDING THE PATIENT¿S HOSPITALIZATION ARE CURRENTLY UNKNOWN. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2.5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH ANY OF THE FRESENIUS PRODUCTS USED, AS WELL AS NO MACHINE ALARMS, CLOTTING EVENTS A
Patient problems: Hemolysis
MAUDE report 8804873 ↗InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT¿S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 9.9 TO 8.1. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2019 WITH A HEMOGLOBIN OF 7.1 AND POSITIVE SCHISTOCYTES. THE PATIENT REQUIRED A BLOOD TRANSFUSION. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. FURTHER DETAILS REGARDING THE PATIENT¿S HOSPITALIZATION ARE CURRENTLY UNKNOWN. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS 160 DIALYZER, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2.5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH A
Patient problems: Hemolysis
MAUDE report 8804729 ↗InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT¿S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD S HEMOGLOBIN OF 9 ON (B)(6) 2019 AND (B)(6) 2019. THE PATIENT WAS ADMITTED INTO THE HOSPITAL WITH HEMOGLOBIN OF 8.9 ON (B)(6) 2019 AND REQUIRED A BLOOD TRANSFUSION. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. FURTHER DETAILS REGARDING THE PATIENT¿S HOSPITALIZATION ARE CURRENTLY UNKNOWN. THE PATIENT¿S HEMOGLOBIN IMPROVED TO 9.9 ON (B)(6) 2019. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS 180 DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2.5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING
Patient problems: Hemolysis
MAUDE report 8804584 ↗InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT¿S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 8.7 TO 8.4. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2019 AND REQUIRED A BLOOD TRANSFUSION. THE PATIENT ALSO HAS A HISTORY OF UNSPECIFIED BLOOD DISORDER AND PREVIOUS BLOOD TRANSFUSION ON (B)(6) 2019.THE PATIENT WAS DISCHARGED ON (B)(6) 2019. FURTHER DETAILS REGARDING THE PATIENT¿S HOSPITALIZATION ARE CURRENTLY UNKNOWN. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2.5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO
Patient problems: Hemolysis
MAUDE report 8804202 ↗InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT¿S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 8.9 TO 7.2. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2019 WITH A HEMOGLOBIN OF 5.9 AND POSITIVE SCHISTOCYTES. THE PATIENT REQUIRED A BLOOD TRANSFUSION. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. FURTHER DETAILS REGARDING THE PATIENT¿S HOSPITALIZATION ARE CURRENTLY UNKNOWN. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS 160 AND 180 DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2.5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECT
Patient problems: Hemolysis
MAUDE report 8804112 ↗InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT¿S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 10.8 TO 6.4. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2019 AND REQUIRED A BLOOD TRANSFUSION. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. FURTHER DETAILS REGARDING THE PATIENT¿S HOSPITALIZATION ARE CURRENTLY UNKNOWN. THE PATIENT¿S HEMOGLOBIN IMPROVED TO 9.9 ON (B)(6) 2019. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2.5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH ANY OF
Patient problems: Hemolysis
MAUDE report 8803380 ↗InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT¿S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 11 TO 9.5. THE PATIENT REQUIRED A BLOOD TRANSFUSION; HOWEVER, THEY WERE NOT ADMITTED TO THE HOSPITAL. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS 180 DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2.5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH ANY OF THE FRESENIUS PRODUCTS USED, AS WELL AS NO MACHINE ALARMS, CLOTTING EVENTS AND/OR DIALYZER LEAKS IN RELATION TO THE HEMOLYSIS EVENT. IT WAS REPORTED THERE WAS NOTHING UNUSUAL IN ANY OF THE HEMODIALYSIS TREATMENTS. THERE WERE NO VISIBLE SIGNS OF HE
Patient problems: Hemolysis
MAUDE report 8802844 ↗InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT¿S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 10.5 TO 9.3. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2019 AND REQUIRED A BLOOD TRANSFUSION. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. FURTHER DETAILS REGARDING THE PATIENT¿S HOSPITALIZATION ARE CURRENTLY UNKNOWN. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2.5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH ANY OF THE FRESENIUS PRODUCTS USED, AS WELL AS NO MACHINE ALARM
Patient problems: Hemolysis
MAUDE report 8802423 ↗InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT A HEMODIALYSIS PATIENT EXPERIENCED HEMOLYSIS EVENT. UPON FOLLOW UP, THE HEMOLYSIS EVENT APPEARS TO HAVE OCCURRED BETWEEN (B)(6) 2019. THE PATIENT¿S PRE-HEMODIALYSIS TREATMENT LABS WERE DRAWN ON (B)(6) 2019 WITHOUT ANY REPORTED ISSUES WITH THE LAB SPECIMEN. ON (B)(6) 2019, THE CLINIC MANAGER REVIEWED THE LAB RESULTS WHICH WERE DRAWN POST HEMODIALYSIS TREATMENT AND NOTICED THE PATIENT HAD A DROP IN THEIR BASELINE HEMOGLOBIN FROM 11 TO 9. THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2019 AND REQUIRED A BLOOD TRANSFUSION. FURTHER DETAILS REGARDING THE PATIENT¿S HOSPITALIZATION ARE CURRENTLY UNKNOWN. REPORTEDLY, THE PATIENT CONTINUES TO RECEIVE HEMODIALYSIS TREATMENTS. THE PATIENT WAS REPORTED DIALYZING WITH A FRESENIUS 2008T HEMODIALYSIS MACHINE, FRESENIUS BLOODLINES, FRESENIUS 180 DIALYZERS, FRESENIUS GRANUFLO ACID (2551) 2.0 POTASSIUM/2.5 CALCIUM, FRESENIUS NATURALYTE 4000 BICARBONATE, FRESENIUS CLIC BLOOD CHAMBER AND FRESENIUS NORMAL SALINE. IT WAS REPORTED THERE WERE NO VISUAL DEFECTS OR ANYTHING UNEXPECTED WITH ANY OF THE FRESENIUS PRODUCTS USED, AS WELL AS NO MACHINE ALARMS, CLOTTING EVENTS AND/OR DIALYZER LEAKS IN
Patient problems: Hemolysis
MAUDE report 8802150 ↗InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED NAUSEA DURING HEMODIALYSIS TREATMENT. A BIOMED TECHNICIAN REPORTED THAT THE BATCH OF NATURALYTE WAS MIXED IMPROPERLY AND CAUSED THE SYMPTOMS IN THE PATIENT. DURING FOLLOW UP WITH THE BIOMED TECHNICIAN IT WAS REPORTED THAT THE NATURALYTE WAS MIXED DURING THE MORNING SHIFT, AND WAS POSSIBLE THERE WERE INCORRECT QUANTITIES MIXED. THERE WERE NO ALARMS. THE CONDUCTIVITY OF THE MACHINE WAS CHECKED AND READ 13.0-13.1. THE CLINIC MANAGER STATED THAT THE PATIENT WAS ABLE TO COMPLETE TREATMENT. THE CLINIC MANAGER STATED THAT A BLOOD TEST WAS PERFORMED AND REVEALED THAT THE BICARBONATE LEVELS WERE SIGNIFICANTLY LOWERED.
Patient problems: Nausea
MAUDE report 7443772 ↗
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- 2008T BlueStar Hemodialysis Machine4 models · 767 reports · 11 recalls
- CombiSet10 models · 819 reports · 1 recall
- stay.safe8 models · 187 reports · 6 recalls
- Bibag2 models · 0 reports · 1 recall
- Crit-Line2 models · 30 reports
- Hemoflow4 models · 29 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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