NaturaLyteRecalls & reported problems across all models

We found 17 models of NaturaLyte by Fresenius Medical Care Renal Therapies Group, LLC in the FDA's device registry (GUDID). Together they are named in 190 adverse event reports in the FDA's MAUDE database, received between Oct 12, 2017 and Dec 6, 2021 — classified as 2 deaths, 8 injuries, 180 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (180 reports).

5 FDA recall records name at least one of these models by its device identifier, 2 still open.

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.

1. Jul 14, 2026Class IIOpen, Classified

   Complaints of blue-green discoloration in product

   Z-3092-2026 · Root cause: Material/Component Contamination · names 8 of these models · Recall details · FDA record ↗

2. Oct 4, 2022Class IIOpen, Classified

   The "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl (calcium chloride) content. The product remains potassium free.

   Z-0181-2023 · Root cause: Error in labeling · Recall details · FDA record ↗

3. Jun 1, 2022Class IITerminated

   The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection.

   Z-1311-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Apr 28, 2021Class IITerminated

   Exposed to freezing temperatures due to refrigerated truck malfunctions

   Z-2086-2021 · Root cause: Environmental control · names 2 of these models · Recall details · FDA record ↗

5. Sep 29, 2017Class IITerminated

   The label specifies the potassium concentration is 2.0 mEq/L. Some of the product in the affected lot was found to have a potassium concentration of 2.25 mEq/L.

   Z-1010-2018 · Root cause: Release of Material/Component prior to receiving test results · Recall details · FDA record ↗

Most reported NaturaLyte problems

NaturaLyte models

17 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NaturaLyte 08-3251-9

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  2 recalls78 reports
• NaturaLyte 08-2251-0

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  3 recalls1 death20 reports
• NaturaLyte 08-2301-3

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  2 recalls35 reports
• NaturaLyte 08-1251-1

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  1 recall9 reports
• NaturaLyte 08-3301-2

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  1 recall6 reports
• NaturaLyte 13-2251-0

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  1 recall5 reports
• NaturaLyte 13-3251-9

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  1 recall2 reports
• NaturaLyte 08-0231-4

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  1 recall1 report
• NaturaLyte 13-2201-5

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  1 recall0 reports
• NaturaLyte 08-2201-5

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  19 reports
• NaturaLyte 08-3231-1

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  4 reports
• NaturaLyte 08-1001-0

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  3 reports
• NaturaLyte 08-2351-8

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  2 reports
• NaturaLyte 08-3201-4

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  2 reports
• NaturaLyte 08-4231-0

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  1 death2 reports
• NaturaLyte 08-1231-3

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  1 report
• NaturaLyte 08-1301-4

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  1 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.

• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FRESENIUS BECAME AWARE (VIA AN ARTICLE IN THE JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY) THIS PATIENT WITH RENAL FAILURE (RF) ON HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) WAS HOSPITALIZED (DATE NOT PROVIDED) DUE TO DEPRESSION AND SUICIDAL IDEATIONS. FURTHER REVIEW OF THE ARTICLE ENTITLED ¿CAUSTIC INJURY AFTER INGESTION OF NATURALYTE,¿ REVEALED THE PATIENT PRESENTED TO THE HOSPITAL WITH HYPERTENSION (235/142) AND AGITATION. HEMATOLOGICAL STUDIES DETERMINED THE PATIENT¿S POTASSIUM WAS 3.7 MMOL/L, AND HIS BICARBONATE WAS 25 MMOL/L. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT TO UNDERGO HD THERAPY, AND DURING SETTING UP, THE PATIENT INTENTIONALLY INGESTED 100 ML OF NATURALYTE TO INFLICT SELF-HARM. IMMEDIATELY AFTER INGESTING THE SOLUTION, THE PATIENT BEGAN TO VOMIT. THE PATIENT WAS EMERGENTLY PLACED ON HD, AND LABORATORY STUDIES INDICATED HIS K+ = 4.1 MMOL/L, PH (VENOUS) = 7.4, AND CO2 = 20 MMOL/L. ALTHOUGH THE EXACT TIMELINE IS UNKNOWN, THE PATIENT UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WHICH REVEALED ESOPHAGITIS AND STOMACH ULCERATION. THE PATIENT WAS REPORTEDLY TREATED WITH PANTOPRAZOLE AND A SUBSEQUENT EGD INDICATED THE PATIENT WAS RECOVERING. THE ART

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; High Blood Pressure/ Hypertension; Vomiting

  MAUDE report 12934204 ↗
• MalfunctionApr 7, 2021Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED RECEIVING LOW CONDUCTIVITY VALUES FROM A LOT OF NATURALYTE ACID CONCENTRATE PRIOR TO INITIATING HEMODIALYSIS (HD) TREATMENT. IT WAS REPORTED THE UNSPECIFIED HD MACHINE ALARMED APPROPRIATELY. THE CONDUCTIVITY VALUES RECEIVED WERE NOT REPORTED. HOWEVER, THE BMT INDICATED THAT THEY SWITCHED THE ACID CONCENTRATE TO A DIFFERENT NATURALYTE PRODUCT TO RESOLVE THE ISSUE. THE BMT ALLEGED THE REPORTED PRODUCT WAS A ¿BAD BATCH OF CONCENTRATE¿. THERE WAS NO PATIENT INVOLVEMENT DURING THE REPORTED EVENT. MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE ADDITIONAL INFORMATION, HOWEVER, A RESPONSE WAS NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11631550 ↗
• MalfunctionApr 1, 2021Chemical Problem; Chemical Problem

  A USER FACILITY INVENTORY TECHNICIAN REPORTED THAT A BATCH OF NATURALYTE ACID CONCENTRATE WAS DEFECTIVE AND RESULTING IN CONDUCTIVITY LEVELS OUTSIDE OF THE EXPECTED RANGE. UPON FOLLOW UP WITH THE USER FACILITY ADMINISTRATOR IT WAS REPORTED THEY DID NOT HAVE PATIENT INFORMATION NOR THE EXACT DATE OF THE EVENT. THEY INDICATED THEY WOULD HAVE TO LOOK FOR THAT INFORMATION. THEY CONFIRMED THAT THE LOW CONDUCTIVITY LEVEL WAS FOUND DURING TREATMENT AND WAS READING SOMEWHERE IN THE HIGH 12 MS/CM, YET WELL OUTSIDE OF THE RANGE TO CAUSE THE FRESENIUS K2 HEMODIALYSIS MACHINE TO ALARM. THE PATIENT RECEIVING TREATMENT WAS ABLE TO CONTINUE TREATMENT AFTER THE NEPHROLOGIST WAS CONTACTED AND THE ACID WAS SWITCHED TO A DIFFERENT UNKNOWN ACID. THE REMAINING JUGS OF THE REPORTED LOT WAS SEQUESTERED AND SCHEDULED TO BE PICKED UP AND RETURNED BY FMC CUSTOMER SERVICE. THEY CONFIRMED THERE WERE NO ADVERSE EVENTS, SERIOUS INJURIES, NOR REQUIRED MEDICAL INTERVENTION FOR THE PATIENTS INVOLVED. THE CLINIC USES NATURALYTE BICARB (UNKNOWN LOT). ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, A RESPONSE WAS NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11603457 ↗
• MalfunctionApr 1, 2021Chemical Problem; Chemical Problem

  A USER FACILITY INVENTORY TECHNICIAN REPORTED THAT A BATCH OF NATURALYTE ACID CONCENTRATE WAS DEFECTIVE AND RESULTING IN CONDUCTIVITY LEVELS OUTSIDE OF THE EXPECTED RANGE. UPON FOLLOW UP WITH THE USER FACILITY ADMINISTRATOR IT WAS REPORTED THEY DID NOT HAVE PATIENT INFORMATION NOR THE EXACT DATE OF THE EVENT. THEY INDICATED THEY WOULD HAVE TO LOOK FOR THAT INFORMATION. THEY CONFIRMED THAT THE LOW CONDUCTIVITY LEVEL WAS FOUND DURING TREATMENT AND WAS READING SOMEWHERE IN THE HIGH 12 MS/CM, YET WELL OUTSIDE OF THE RANGE TO CAUSE THE FRESENIUS K2 HEMODIALYSIS MACHINE TO ALARM. THE PATIENT RECEIVING TREATMENT WAS ABLE TO CONTINUE TREATMENT AFTER THE NEPHROLOGIST WAS CONTACTED AND THE ACID WAS SWITCHED TO A DIFFERENT UNKNOWN ACID. THE REMAINING JUGS OF THE REPORTED LOT WAS SEQUESTERED AND SCHEDULED TO BE PICKED UP AND RETURNED BY FMC CUSTOMER SERVICE. THEY CONFIRMED THERE WERE NO ADVERSE EVENTS, SERIOUS INJURIES, NOR REQUIRED MEDICAL INTERVENTION FOR THE PATIENTS INVOLVED. THE CLINIC USES NATURALYTE BICARB (UNKNOWN LOT). ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, A RESPONSE WAS NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11603456 ↗
• MalfunctionApr 1, 2021Chemical Problem; Chemical Problem

  A USER FACILITY INVENTORY TECHNICIAN REPORTED THAT A BATCH OF NATURALYTE ACID CONCENTRATE WAS DEFECTIVE AND RESULTING IN CONDUCTIVITY LEVELS OUTSIDE OF THE EXPECTED RANGE. UPON FOLLOW UP WITH THE USER FACILITY ADMINISTRATOR IT WAS REPORTED THEY DID NOT HAVE PATIENT INFORMATION NOR THE EXACT DATE OF THE EVENT. THEY INDICATED THEY WOULD HAVE TO LOOK FOR THAT INFORMATION. THEY CONFIRMED THAT THE LOW CONDUCTIVITY LEVEL WAS FOUND DURING TREATMENT AND WAS READING SOMEWHERE IN THE HIGH 12 MS/CM, YET WELL OUTSIDE OF THE RANGE TO CAUSE THE FRESENIUS K2 HEMODIALYSIS MACHINE TO ALARM. THE PATIENT RECEIVING TREATMENT WAS ABLE TO CONTINUE TREATMENT AFTER THE NEPHROLOGIST WAS CONTACTED AND THE ACID WAS SWITCHED TO A DIFFERENT UNKNOWN ACID. THE REMAINING JUGS OF THE REPORTED LOT WAS SEQUESTERED AND SCHEDULED TO BE PICKED UP AND RETURNED BY FMC CUSTOMER SERVICE. THEY CONFIRMED THERE WERE NO ADVERSE EVENTS, SERIOUS INJURIES, NOR REQUIRED MEDICAL INTERVENTION FOR THE PATIENTS INVOLVED. THE CLINIC USES NATURALYTE BICARB (UNKNOWN LOT). ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, A RESPONSE WAS NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11603174 ↗
• MalfunctionApr 1, 2021Chemical Problem; Chemical Problem

  A USER FACILITY INVENTORY TECHNICIAN REPORTED THAT A BATCH OF NATURALYTE ACID CONCENTRATE WAS DEFECTIVE AND RESULTING IN CONDUCTIVITY LEVELS OUTSIDE OF THE EXPECTED RANGE. UPON FOLLOW UP WITH THE USER FACILITY ADMINISTRATOR IT WAS REPORTED THEY DID NOT HAVE PATIENT INFORMATION, THE LOT INVOLVED, NOR THE EXACT DATE OF THE EVENT. THEY INDICATED THEY WOULD HAVE TO LOOK FOR THAT INFORMATION. THEY CONFIRMED THAT THE LOW CONDUCTIVITY LEVEL WAS FOUND DURING TREATMENT AND WAS READING SOMEWHERE IN THE HIGH 12 MS/CM, YET WELL OUTSIDE OF THE RANGE TO CAUSE THE FRESENIUS K2 HEMODIALYSIS MACHINE TO ALARM. THE PATIENT RECEIVING TREATMENT WAS ABLE TO CONTINUE TREATMENT AFTER THE NEPHROLOGIST WAS CONTACTED AND THE ACID WAS SWITCHED TO A DIFFERENT UNKNOWN ACID. THE REMAINING JUGS OF THE REPORTED LOT WAS SEQUESTERED AND SCHEDULED TO BE PICKED UP AND RETURNED BY FMC CUSTOMER SERVICE. THEY CONFIRMED THERE WERE NO ADVERSE EVENTS, SERIOUS INJURIES, NOR REQUIRED MEDICAL INTERVENTION FOR THE PATIENTS INVOLVED. THE CLINIC USES NATURALYTE BICARB (UNKNOWN LOT). ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, A RESPONSE WAS NOT RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11603171 ↗
• MalfunctionMar 26, 2021Chemical Problem; Chemical Problem

  A FRESENIUS USER FACILITY BIOMEDICAL TECHNICAL REPORTED A JUG OF NATURALYTE LIQUID ACID CONCENTRATE WAS RESULTING IN LOW CONDUCTIVITY RESULTS ON AN UNSPECIFIED HEMODIALYSIS (HD) MACHINE. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING TREATMENT. THE REPORTED JUG WAS TAKEN OUT OF SERVICE. THE SAMPLE WAS REPORTEDLY AVAILABLE TO BE RETURNED TO THE MANUFACTURER. MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE ADDITIONAL INFORMATION, HOWEVER, A RESPONSE WAS NOT RECEIVED. IT IS UNKNOWN IF THESE EVENTS RESULTED IN ANY ADVERSE EVENT OR REQUIRED MEDICAL INTERVENTION. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11575566 ↗
• MalfunctionFeb 25, 2021Chemical Problem; Chemical Problem

  A BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A 2008T HEMODIALYSIS (HD) MACHINE WAS ALARMING LOW CONDUCTIVITY WHILE UTILIZING A LOW SODIUM BATCH OF NATURALYTE DURING SETUP. UPON FOLLOW UP, THE BMT CONFIRMED HE OBSERVED THE LOW CONDUCTIVITY ALARM AND VALUES ON ONE MACHINE DURING SETUP. THE THEORETICAL CONDUCTIVITY (TCD) WAS 13.7 MS/CM AND THE ACTUAL CONDUCTIVITY WAS BOUNCING BETWEEN 13.2 ¿ 13.3 MS/CM. THE ISSUE WAS RESOLVED AFTER REPLACING THE NATURALYTE WITH LOT#: 20CXA3044. HE CONFIRMED THERE WAS NO PATIENT INVOLVEMENT. THE BI-BICARB USED WAS PART#: 08-4080-BB, LOT# IS UNKNOWN. THERE WERE 6 GALLONS REMAINING OF THE REPORTED NATURALYTE LOT WHEN THE ISSUE OCCURRED. HE IS UNSURE IF THE CLINIC HAS USED THE REMAINING JUGS. THE BMT INDICATED HE WOULD FOLLOW UP IF SAMPLES WERE AVAILABLE TO RETURN FOR PHYSICAL EVALUATION. THERE WERE NO SERIOUS ADVERSE EVENTS, INJURIES, NOR REQUIRED MEDICAL INTERVENTION ATTRIBUTED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11381713 ↗
• MalfunctionFeb 25, 2021Chemical Problem; Chemical Problem

  A USER FACILITY REPORTED THAT DURING SETUP A HEMODIALYSIS (HD) MACHINE DISPLAYED LOW CONDUCTIVITY VALUES FOR NATURALYTE PRODUCT. THE MACHINE ACTUAL CONDUCTIVITY WAS 12.9 MS/CM WHILE THE NORMAL PARAMETERS WERE 13.5 ¿ 14.5 MS/CM. THE JUG OF NATURALYTE WAS SWITCHED OUT FOR A DIFFERENT JUG OF THE SAME LOT, HOWEVER, THE ISSUE PERSISTED. TO RESOLVE THE ISSUE THEY SWITCHED OUT THE JUG OF NATURALYTE FOR A DIFFERENT LOT. THEY WERE ABLE TO INITIATE AND COMPLETE THE TREATMENT AFTER SWITCHING TO A DIFFERENT LOT OF NATURALYTE. IT WAS CONFIRMED NO OTHER LOW CONDUCTIVITY ISSUES OCCURRED DURING SETUP OR TREATMENT. DURING THE INITIAL FOLLOW UP, THE RISK MANAGEMENT REPRESENTATIVE INDICATED HE WAS UNAWARES OF SAMPLE AVAILABILITY. UPON FURTHER FOLLOW UP, IT WAS REPORTED THERE WERE NO SAMPLES AVAILABLE TO RETURN FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11381383 ↗
• MalfunctionFeb 22, 2021Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A LOT OF NATURALYTE CONCENTRATE ACID HAD CAUSED THE HEMODIALYSIS (HD) MACHINE TO ALARM LOW CONDUCTIVITY DURING HD TREATMENT. THEY SWITCHED THE CONCENTRATES AND WERE ABLE TO CONTINUE TREATMENT. UPON FOLLOW UP, THE BMT CONFIRMED THAT NO ADVERSE EVENTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE TREATMENT WAS COMPLETED WITH THE SAME MACHINE AFTER SWITCHING TO A DIFFERENT LOT OF NATURALYTE ACID. HE INDICATED THAT THE LOT OF NATURALYTE THEY USED WAS LABELED LOW SODIUM, BUT THEY WERE NOT AWARE AT THE TIME OF SETUP. THE BMT INDICATES THAT THE CAUSE OF THE LOW CONDUCTIVITY WAS A STEP THAT WAS MISSED WITH THE BICARB AFTER THE ACID WAS FED TO THE TREATMENT AREA. THEY WERE ABLE TO COMPLETE MORE TREATMENTS WITH THE SAME LOT OF NATURALYTE WITHOUT EXPERIENCING ANY LOW CONDUCTIVITY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11363236 ↗
• MalfunctionFeb 15, 2021Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT ONE OF THE ACID CONCENTRATES (CATALOG # 08-3231-1, LOT # 20LXAC090) HE USES HAS BEEN MANUFACTURED WITH A LOWER SODIUM CONCENTRATION. HE STATED HE IS HAVING DIFFICULTY ADJUSTING THE CONDUCTIVITY ALARM LIMITS SO THAT IT WILL NOT ALARM. TECHNICAL SUPPORT EXPLAINED THAT THE CONCENTRATE IS NOT TO BE USED AND EMAILED FORM FA-2020-41-X RECALL AND FA-2021-02-D, WHICH STATES NOT TO USE IT AND THE AFFECTED LOT NUMBERS. THERE WAS NO PATIENT INVOLVEMENT, NO HARM OR ADVERSE EVENT REPORTED AS THE ISSUE OCCURRED PRIOR TO TREATMENT. DURING FOLLOW UP, THE BMT CONFIRMED THE EVENT OCCURRED PRIOR TO TREATMENT. HE INDICATED THIS LOT NEVER HAD CONDUCTIVITY ISSUES BEFORE. THERE ARE NO SAMPLES OF THE REPORTED LOT AVAILABLE TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11327738 ↗
• MalfunctionFeb 12, 2021Chemical Problem; Chemical Problem

  A BIOMEDICAL TECHNICIAN (BMT) REPORTED LOW CONDUCTIVITY ALARMS FROM A HEMODIALYSIS (HD) MACHINE WHILE UTILIZING A BATCH OF NATURALYTE ACID CONCENTRATE DURING TESTING. THE MACHINE CONDUCTIVITY VALUE WAS READING 13.2 MS/CM AND THE THEORETICAL CONDUCTIVITY VALUE WAS 13.5 MS/CM. AFTER CALIBRATING THE BICARBONATE PUMP, ACID PUMP, CONDUCTIVITY CELLS, AND THE BALANCING CHAMBER, THE CONDUCTIVITY LEVELS REMAINED AT 13.2 MS/CM. THE ISSUE WAS RESOLVED AFTER CHANGING THE ACID TO DIFFERENT LOT. UPON FOLLOW UP, THE BMT CONFIRMED THERE WAS NO PATIENT INVOLVEMENT DURING THE LOW CONDUCTIVITY VALUES HE OBSERVED. UPON FOLLOW UP WITH THE FACILITY MANAGER, IT WAS INDICATED THAT THERE WERE NO SAMPLES AVAILABLE FOR EVALUATION. THE FACILITY MANAGER INDICATED THAT THE REPORTED BATCH WAS ONE OF THE LOTS LISTED ON THE VOLUNTARY RECALL LIST THEY RECEIVED FROM FRESENIUS. THE LOT NUMBER OF THE PRODUCT WAS REQUESTED BUT IS NOT AVAILABLE DUE TO ALL PRODUCT BEING DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11324338 ↗
• MalfunctionFeb 12, 2021Chemical Problem; Chemical Problem

  A BIOMEDICAL TECHNICIAN (BMT) WAS PERFORMING SERVICE ON A HEMODIALYSIS (HD) MACHINE DUE TO LOW CONDUCTIVITY ALARMS. UPON FOLLOW UP WITH THE FACILITY MANAGER, IT WAS REPORTED THAT THE LOW CONDUCTIVITY ALARMS OCCURRED DURING HD TREATMENT. THE ACTUAL AND THEORETICAL CONDUCTIVITY VALUES ARE UNAVAILABLE. THE PATIENT WAS ABLE TO COMPLETE THEIR HD TREATMENT WITH THE SAME MACHINE AND SAME SUPPLIES. THERE WAS NO ADVERSE EVENT, SERIOUS INJURY, NOR MEDICAL INTERVENTION ATTRIBUTED TO THE REPORTED EVENT. PATIENT INFORMATION IS NOT AVAILABLE. THERE ARE NO SAMPLES AVAILABLE TO RETURN FOR EVALUATION. THE FACILITY MANAGER INDICATED THAT THE REPORTED BATCH WAS ONE OF THE LOTS LISTED ON THE VOLUNTARY RECALL LIST THEY RECEIVED FROM FRESENIUS. THE LOT NUMBER OF THE PRODUCT WAS REQUESTED BUT IS NOT AVAILABLE DUE TO ALL PRODUCT BEING DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11324320 ↗
• MalfunctionFeb 12, 2021Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A LOT OF NATURALYTE CONCENTRATE ACID HAD CAUSED THE HEMODIALYSIS (HD) MACHINE TO ALARM LOW CONDUCTIVITY DURING HD TREATMENT. THEY SWITCHED THE CONCENTRATES AND WERE ABLE TO CONTINUE TREATMENT. UPON FOLLOW UP, THE BMT CONFIRMED THAT NO ADVERSE EVENTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE TREATMENT WAS COMPLETED WITH THE SAME MACHINE AFTER SWITCHING TO A DIFFERENT LOT OF NATURALYTE ACID. HE INDICATED THAT THE LOT OF NATURALYTE THEY USED WAS LABELED LOW SODIUM, BUT THEY WERE NOT AWARE AT THE TIME OF SETUP. THE BMT INDICATES THAT THE CAUSE OF THE LOW CONDUCTIVITY WAS A STEP THAT WAS MISSED WITH THE BICARB AFTER THE ACID WAS FED TO THE TREATMENT AREA. THEY WERE ABLE TO COMPLETE MORE TREATMENTS WITH THE SAME LOT OF NATURALYTE WITHOUT EXPERIENCING ANY LOW CONDUCTIVITY ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11324207 ↗
• DeathDec 7, 2020Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED VIA EMAIL THE HEMODIALYSIS (HD) MACHINE CONDUCTIVITY IS RUNNING LOWER THAN EXPECTED WITH A SPECIFIC LOT OF NATURALYTE. PER THE BIOMED, WHEN A NEW LOT WAS USED, THE CONDUCTIVITY INCREASED FROM 13.1MS/CM TO 13.5 MS/CM. UPON FOLLOW UP RECEIVED FROM THE BIOMED ON 16-NOV-2020, THE BIOMED REPORTED DURING USE, THE CONDUCTIVITY WAS AT 13.1 MS/CM AND THEORETICAL CONDUCTIVITY VALUE (TCD) WAS 13.4 MS/CM. THE CONDUCTIVITY ISSUE WAS EXPERIENCED WHILE PERFORMING FUNCTIONAL TESTING ON (B)(6) 2020 ON THE FRESENIUS 2008T HD MACHINE, SERIAL NUMBER (B)(4), AFTER A PATIENT EVENT OCCURRED. THE BIOMED REPORTED THE PRODUCT WAS USED FOR A TREATMENT WHICH ENDED WITH A PATIENT EXPIRING. THE BIOMED USED NATURALYTE 08-2251-0, LOT NUMBER 20NTAC065, TO VERIFY CONDUCTIVITY WHICH CHANGED TO 13.5 MS/CM. THE BIOMED STATED NO SERVICE HAD BEEN DONE TO THE MACHINE RECENTLY AND THE MACHINE WAS REMOVED FROM SERVICE AND PENDING RELEASE AFTER THE EVENT OCCURRED ON (B)(6) 2020. THE TREATMENT WAS PERFORMED USING A BIBAG WHICH WAS DISPOSED OF PRIOR TO RECEIVING THE MACHINE FOR FUNCTIONAL TESTING AND THAT THE NATURALYTE USED DURING TREATMENT WAS DISCARDED. ADDITIONALLY,

  Patient problems: Death

  MAUDE report 10961173 ↗

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