NaturaLyte 08-2301-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00840861101702), received between Nov 25, 2020 and Apr 1, 2021 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (35 reports).

2 FDA recall records name this device's identifier, 1 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, 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.

Recalls naming this device

1. Jul 14, 2026Open, Classified

   Complaints of blue-green discoloration in product

   Z-3092-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

2. Jun 1, 2022Terminated

   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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED VIA FAX THAT THE HEMODIALYSIS (HD) MACHINES ARE HAVING CONDUCTIVITY ISSUES WITH THE USE OF NATURALYTE. UPON FOLLOW UP, THE CUSTOMER PROVIDED DETAILS OF ONE LOW CONDUCTIVITY OCCURRENCE DURING TREATMENT, HOWEVER, SPECIFICS DETAILS ON THE LOW CONDUCTIVITY EXPERIENCED BY OTHER MACHINES WERE NOT PROVIDED. THIS RECORD CAPTURES THE ALLEGED NATURALYTE BATCH LOW CONDUCTIVITY RESULTS EXPERIENCED ON THE OTHER MACHINES. IT IS UNKNOWN IF THESE OCCURRENCES WERE DURING TREATMENT OR SETUP. FIVE CASES WERE AFFECTED. THE BMT HAS NOT BEEN IN TOUCH WITH CUSTOMER SERVICE TO RETURN ANY AFFECTED PRODUCT. NO REPAIRS TO THE MACHINES WERE PERFORMED. THE CLINIC USES NATURALYTE BICARBONATE LOT 20HXBC010. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, A RESPONSE WAS NOT RECEIVED. A SAMPLE RETURN IS NOT EXPECTED.

  Patient problems: No Patient Involvement

  MAUDE report 10933203 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED A NATURALYTE BATCH RESULTED IN LOW CONDUCTIVITY VALUES. UPON FOLLOW UP, THE BIOMED REPORTED THAT BEFORE USE, THE CONDUCTIVITY WAS 12.8 MS/CM. THE THEORETICAL CONDUCTIVITY VALUE PROGRAMMED IN THE HD MACHINE WAS NOT PROVIDED. THE BIOMED IS UNSURE IF THE BATCH WAS EVER USED FOR HD TREATMENT, HOWEVER, HE INDICATED HE HAS NOT BEEN MADE AWARE OF ANY ADVERSE EVENT OR SERIOUS INJURY ATTRIBUTED TO LOW CONDUCTIVITY LEVELS OF THE REPORTED BATCH. HE CONFIRMED THE CLINIC USED A DIFFERENT BATCH OF NATURALYTE (LOT # UNKNOWN) TO AVOID CONDUCTIVITY ISSUES. PER THE BIOMED, 22 CASES OF NATURALYTE WERE AFFECTED. PER THE BIOMED THERE HAS NOT BEEN A RETURN GOODS AUTHORIZATION ISSUED FOR THIS PRODUCT. THE BIOMED REPORTED THAT THERE HAS NOT BEEN ANY SERVICE TO THE MACHINES. THE CLINIC USES NATURALYTE BICARBONATE, THE TYPE AND LOT OF THE PRODUCT WAS UNKNOWN. A SAMPLE RETURN IS NOT EXPECTED FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 10932945 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. UPON FOLLOW UP, THE BIOMED REPORTED THAT BEFORE USE, THE NATURALYTES CONDUCTIVITY VALUE WOULD NOT GO ABOVE 12.9 MS/CM AND WAS BELOW THE MINIMUM THEORETICAL CONDUCTIVITY VALUE. NO PATIENTS WERE TREATED WITH THE LOT. PER THE BIOMED, 1 JUG IS AFFECTED, AND THEY ARE CURRENTLY USING NATURALYTE LOT 20DXAC106 WITHOUT ANY ISSUES. THE BIOMED REPORTED THAT THERE HAS NOT BEEN ANY RECENT SERVICE TO THE MACHINES, AND THEY USE BICARBONATE 4000RX12 LOT NUMBER: 20KXBC004. SAMPLES OF THE REPORTED BATCH OF NATURALYTE ARE AVAILABLE. FURTHER FOLLOW UP WAS MADE TO ATTEMPT TO SCHEDULE A PICKUP, AND RETURN OF THE SAMPLE, HOWEVER, A RESPONSE WAS NOT RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 10932719 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY THE NATURALYTE THAT HAD LOW CONDUCTIVITY VALUES WHILE TESTING ON AN HD MACHINE. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER TO DATE HAS NOT BEEN PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10932692 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY THE NATURALYTE THAT HAD LOW CONDUCTIVITY VALUES WHILE TESTING ON AN HD MACHINE. UPON FOLLOW UP, THE BIOMED REPORTED THE LOT OF NATURALYTE HAS AN UNSPECIFIED CONDUCTIVITY VALUE THAT WAS AT OR BELOW THE THEORETICAL CONDUCTIVITY VALUE SETTING ON THE MACHINE. NO PATIENTS WERE TREATED WITH THE PRODUCT. THE BIOMED STATED THAT MORE THAN ONE JUG WAS AFFECTED, HOWEVER DID NOT SPECIFY THE AMOUNT. PER BIOMED THEY HAVE SUCCESSFULLY USED NATURALYTE LOTS 20NXAC013 AND 20LXAC038. THE BIOMED REPORTED THAT THERE WAS NO SERVICE TO THE MACHINES AND THAT THEY USE BICARBONATE NATURALYTE RX-12, LOT 20HXBC010.

  Patient problems: No Patient Involvement

  MAUDE report 10932631 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. UPON FOLLOW UP, THE BIOMED REPORTED THAT BEFORE USE, THE CONDUCTIVITY WAS AT OR BELOW THE LOWER THEORETICAL CONDUCTIVITY (TCD) LIMIT. NO PATIENTS WERE TREATED WITH THE PRODUCT. THE BIOMED STATED THAT MORE THAN ONE JUG WAS AFFECTED, HOWEVER, DID NOT SPECIFY THE AMOUNT. PER BIOMED THEY HAVE SUCCESSFULLY USED NATURALYTE LOTS: 20NXAC013 AND 20LXAC038. THE BIOMED REPORTED THAT THERE WAS NO SERVICE TO THE MACHINES AND THAT THEY USE BICARBONATE NATURALYTE RX-12, LOT : 20HXBC010.

  Patient problems: No Patient Involvement

  MAUDE report 10932562 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED A NATURALYTE BATCH RESULTED IN LOW CONDUCTIVITY VALUES. UPON FOLLOW UP, THE BIOMED REPORTED THAT BEFORE USE, THE CONDUCTIVITY WAS 12.8. THE BIOMED DID NOT KNOW IF ANY PATIENTS WERE TREATED AND THEY STATED THAT THEY DID NOT HAVE ANY KNOWLEDGE OF ANY ADVERSE EVENTS RELATED TO THE REPORTED EVENT. THE BIOMED DID NOT KNOW WHAT LOT OF NATURALYTE WAS USED SUCCESSFULLY. PER THE BIOMED, EIGHT CASES OF NATURALYTE WERE AFFECTED. PER THE BIOMED THERE HAS NOT BEEN A RETURN GOODS AUTHORIZATION ISSUED FOR THIS PRODUCT. THE BIOMED REPORTED THAT THERE HAS NOT BEEN ANY SERVICE TO THE MACHINES. THE CLINIC USES NATURALYTE BICARBONATE, THE TYPE AND LOT OF THE PRODUCT WAS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 10932403 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT SOME NATURALYTE HAD LOW CONDUCTIVITY AND FOUR CASES WERE PULLED FROM THE SHELF. UPON FOLLOW UP, THE CUSTOMER SAID THAT THE CONDUCTIVITY WAS AT 13.2-13.3 AND THE MACHINE ALARMED LOW CONDUCTIVITY. THE BIOMED STATED THE PRODUCT WAS WITHIN RANGE, SO IT WAS USED FOR PATIENT TREATMENT WITHOUT ISSUES. THERE WAS NO PATIENT ADVERSE EVENT. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Patient Involvement

  MAUDE report 10931485 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. THE BIOMEDICAL TECHNICIAN STATED THEY CALIBRATED THE MACHINE, HOWEVER THE ISSUE WAS NOT RESOLVED. THE SPECIFIC GRAVITY READING WAS OBTAINED USING A HYDROMETER AND THE READING WAS LOW: 1.188 (UNITS UNKNOWN). THE LOT NUMBER OF THE NATURALYTE USED WAS CHANGED AND THE CONDUCTIVITY WAS WITHIN RANGE. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER TO DATE HAS NOT BEEN RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 10931362 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC FACILITY ADMINISTRATOR REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. THE FACILITY ADMINISTRATOR STATED THEY HAD 8 CASES OF THE EFFECTED LOT. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER TO DATE HAS NOT BEEN PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10931245 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT NATURALYTE HAD LOW CONDUCTIVITY. THE BIOMED REPORTED THAT THERE WAS NO SERVICE TO THE MACHINES, AND THAT THEY USE BICARBONATE NATURALYTE LOT NUMBER: 20LXAC016.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10928841 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC ADMINISTRATIVE ASSISTANT REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY RECEIVED 7 CASES OF NATURALYTE THAT ARE UNABLE TO BE USED DUE TO THE PRODUCT BEING LOW IN CONDUCTIVITY RANGE DURING PRE-TREATMENT SETUP. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER TO DATE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10927221 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT SOME NATURALYTE HAD LOW CONDUCTIVITY AND FOUR CASES WERE PULLED FROM THE SHELF. UPON FOLLOW UP, THE CUSTOMER SAID THAT THE CONDUCTIVITY WAS AT 13.2-13.3 MS/CM AND THE MACHINE ALARMED LOW CONDUCTIVITY. THE BIOMED STATED THE PRODUCT WAS WITHIN THE ACCEPTABLE RANGE, SO IT WAS USED FOR PATIENT TREATMENT WITHOUT ISSUES. THERE WAS NO PATIENT ADVERSE EVENT. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10925951 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMED REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY DURING TREATMENTS AT OTHER CLINICS, HOWEVER HAS NOT BEEN USED AT THE REPORTING CLINIC. A RETURNED GOODS AUTHORIZATION (RGA) WAS ISSUED FOR PRODUCT RETURN. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER TO DATE HAS NOT BEEN PROVIDED. THE NUMBER OF OTHER CLINICS THAT EXPERIENCED LOW CONDUCTIVITY WITH THE REPORTED BATCH IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10925938 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT SOME NATURALYTE HAD LOW CONDUCTIVITY. UPON FOLLOW UP, THE CUSTOMER SAID THAT BEFORE USE, THE CONDUCTIVITY WAS AT 12.9MS/CM. THE THEORETICAL CONDUCTIVITY VALUE (TCD) SETTING ON THE MACHINE WAS NOT PROVIDED, AND THE DIFFERENCE BETWEEN ACTUAL CONDUCTIVITY IS UNKNOWN. THE BIOMED STATED THAT SIX AND A HALF CASES ARE AFFECTED. THE PRODUCT WAS USED FOR PATIENT TREATMENT WITHOUT CONDUCTIVITY ISSUES. THERE WAS NO PATIENT ADVERSE EVENT. THE BIOMED REPORTED THAT THE MACHINES HAVE HAD PRODUCT MAINTENANCE, BUT NO OTHER SERVICE TO ANY OF THE MACHINES. THE BIOMED STATED THEY USED NATURALYTE WITH LOT NUMBER 20DXAC106 SUCCESSFULLY WITH NO FURTHER ISSUES. THE FACILITY WAS USING BICARBONATE BIBAG 400RX12; LOT#: 20KXBC004. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10925929 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. UPON FOLLOW UP, THE BIOMED REPORTED THAT DURING USE, THE CONDUCTIVITY WAS AT 13.0 MS/CM. THE THEORETICAL CONDUCTIVITY VALUE (TCD) SETTING ON THE MACHINE WAS NOT PROVIDED AND THE DIFFERENCE BETWEEN ACTUAL CONDUCTIVITY IS UNKNOWN. THE PATIENT COMPLETED TREATMENT WITH THE PRODUCT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. PER THE BIOMED, 12 JUGS ARE AFFECTED. THE BIOMED REPORTED THAT THERE WAS NO SERVICE TO THE MACHINES AND THAT THEY USE BICARBONATE NATURALYTE 4000RX12, LOT NUMBER 20HXBC011. NO SAMPLES WERE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10925918 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. THE BIOMED REPORTED THAT THE CONDUCTIVITY WOULD NOT GO ABOVE 13.0MS/CM. THE THEORETICAL CONDUCTIVITY VALUE (TCD) SETTING ON THE MACHINE WAS NOT PROVIDED AND THE DIFFERENCE BETWEEN ACTUAL CONDUCTIVITY IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER TO DATE HAS NOT BEEN PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10925909 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC REGISTERED NURSE REPORTED BY FAX THAT THEY PULLED ASIDE A LOT OF NATURALYTE SUSPECTED TO HAVE LOW CONDUCTIVITY. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER TO DATE HAS NOT BEEN PROVIDED. IT IS UNKNOWN IF THE PRODUCT WAS DISCOVERED TO HAVE LOW CONDUCTIVITY DURING TREATMENT OR TESTING.

  Patient problems: No Patient Involvement

  MAUDE report 10925855 ↗
• MalfunctionNov 30, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. UPON FOLLOW UP, THE BIOMED REPORTED THAT THE CONDUCTIVITY WAS AT 13.1 MS/CM. THE THEORETICAL CONDUCTIVITY VALUE (TCD) SETTING ON THE MACHINE WAS NOT PROVIDED AND THE DIFFERENCE BETWEEN ACTUAL CONDUCTIVITY IS UNKNOWN. NO PATIENTS WERE TREATED WITH THE LOT. PER THE BIOMED, SIX JUGS WERE AFFECTED, AND SEVEN CASES WERE SET ASIDE. THE BIOMED REPORTED THAT THERE WAS NO SERVICE TO THE MACHINES AND THAT THEY USE CENTRISOL FOR BICARBONATE. THE BIOMED REPORTED THAT A SAMPLE WAS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 10924533 ↗
• MalfunctionNov 29, 2020Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED VIA FAX THAT THE HEMODIALYSIS (HD) MACHINES ARE HAVING CONDUCTIVITY ISSUES WITH THE USE OF NATURALYTE. UPON FOLLOW UP, THE CUSTOMER SAID THAT DURING TREATMENT, THE CONDUCTIVITY WAS AT 12.9 MS/CM, HOWEVER THE THEORETICAL CONDUCTIVITY VALUE (TCD) WAS SET TO 13.5 MS/CM. THE PATIENT WAS SWITCHED TO ANOTHER LOT OF NATURALYTE MID-TREATMENT WITHOUT ANY ILL EFFECTS OR ADVERSE EVENTS. FIVE CASES WERE AFFECTED. HE HAS NOT BEEN IN TOUCH WITH CUSTOMER SERVICE TO RETURN ANY AFFECTED PRODUCT. NO REPAIRS TO THE MACHINE. THEY USE NATURALYTE BICARBONATE LOT 20HXBC010.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10916197 ↗
• MalfunctionNov 29, 2020Chemical Problem; Chemical Problem

  A FRESENIUS SALES MANAGER (FSM)REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A HEMODIALYSIS (HD) CLINIC REPORTED OUT OF RANGE CONDUCTIVITY LEVELS WITH NATURALYTE DURING TESTING/SET-UP PRIOR TO INITIATING TREATMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. UPON FOLLOW UP, THE FSM REPORTED DURING SETUP THE CONDUCTIVITY WAS AT 13.1 MS/CM AND THE THEORETICAL CONDUCTIVITY VALUE (TCD) WAS SET TO 13.7 MS/CM. HE CONFIRMED NO PATIENTS WERE TREATED WITH THIS BATCH. THERE WAS NO RECENT SERVICE TO THE MACHINE. THERE WERE A TOTAL OF 47 CASES OF THIS REPORTED LOT. THE FSM WAS INFORMED A PICK UP WILL BE SCHEDULED FOR A SAMPLE RETURN. THEY ARE CURRENTLY USING NATURALYTE BICARBONATE, PRODUCT AND LOT NUMBER ARE UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 10916189 ↗
• MalfunctionNov 29, 2020Chemical Problem; Chemical Problem

  A FRESENIUS SALES MANAGER (FSM)REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A HEMODIALYSIS (HD) CLINIC REPORTED OUT OF RANGE CONDUCTIVITY LEVELS WITH NATURALYTE DURING TESTING/SET-UP PRIOR TO INITIATING TREATMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. UPON FOLLOW UP, THE FSM REPORTED DURING SETUP THE CONDUCTIVITY WAS AT 13.1 MS/CM AND THE THEORETICAL CONDUCTIVITY VALUE (TCD) WAS SET TO 13.7 MS/CM. HE CONFIRMED NO PATIENTS WERE TREATED WITH THIS BATCH. THERE WAS NO RECENT SERVICE TO THE MACHINE. THERE WERE A TOTAL OF 47 CASES OF THIS REPORTED LOT. THE FSM WAS INFORMED A PICK UP WILL BE SCHEDULED FOR A SAMPLE RETURN. THEY ARE CURRENTLY USING NATURALYTE BICARBONATE, PRODUCT AND LOT NUMBER ARE UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 10916188 ↗
• MalfunctionNov 29, 2020Chemical Problem; Chemical Problem

  A FRESENIUS SALES MANAGER (FSM)REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A HEMODIALYSIS (HD) CLINIC REPORTED OUT OF RANGE CONDUCTIVITY LEVELS WITH NATURALYTE DURING TESTING/SET-UP PRIOR TO INITIATING TREATMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. UPON FOLLOW UP, THE FSM REPORTED DURING SETUP THE CONDUCTIVITY WAS AT 13.1 MS/CM AND THE THEORETICAL CONDUCTIVITY VALUE (TCD) WAS SET TO 13.7 MS/CM. HE CONFIRMED NO PATIENTS WERE TREATED WITH THIS BATCH. THERE WAS NO RECENT SERVICE TO THE MACHINE. THERE WERE A TOTAL OF 47 CASES OF THIS REPORTED LOT. THE FSM WAS INFORMED A PICK UP WILL BE SCHEDULED FOR A SAMPLE RETURN. THEY ARE CURRENTLY USING NATURALYTE BICARBONATE, PRODUCT AND LOT NUMBER ARE UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 10916187 ↗