NaturaLyte 08-2201-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00840861101672), received between Nov 25, 2020 and Apr 1, 2021 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (19 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 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 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 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY RECEIVED LOW CONDUCTIVITY VALUES FROM NATURALYTE DURING TESTING WITH AN HD MACHINE. THE REPORTED CONDUCTIVITY VALUES WERE IN THE RANGE OF 12.8 AND 13.1 MS/CM. THE THEORETICAL CONDUCTIVITY VALUES WERE NOT PROVIDED. THE CONDUCTIVITY VALUES RETURNED WITHIN ACCEPTABLE RANGE AFTER SWITCHING THE ACID BLEND FOR AN UNSPECIFIED PRODUCT. THERE ARE STILL CASES OF THE REPORTED NATURALYTE BATCH SEQUESTERED AT THE CLINIC. THERE WAS NO INDICATION IN THE INITIAL REPORT THAT THE ALLEGED PRODUCT WAS USED IN PATIENT TREATMENT OR CONTRIBUTED TO AN ADVERSE EVENT. MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE ADDITIONAL INFORMATION, HOWEVER, A RESPONSE WAS NOT RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 10933422 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC AREA TECHNICAL OPERATIONS MANAGER (OM) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY RECEIVED LOW CONDUCTIVITY VALUES FROM NATURALYTE DURING TESTING WITH AN UNSPECIFIED NUMBER OF HD MACHINES. SEVERAL MACHINES ALARMED FOR LOW CONDUCTIVITY. THE REPORTED CONDUCTIVITY VALUES WERE IN THE RANGE OF 12.8 AND 13.1 MS/CM. THE THEORETICAL CONDUCTIVITY VALUES WERE NOT PROVIDED. THE CONDUCTIVITY VALUES RETURNED WITHIN ACCEPTABLE RANGE AFTER SWITCHING THE ACID BLEND FOR AN UNSPECIFIED PRODUCT. THERE ARE STILL CASES OF THE REPORTED NATURALYTE BATCH SEQUESTERED AT THE CLINIC. THERE WAS NO INDICATION IN THE INITIAL REPORT THAT THE ALLEGED PRODUCT WAS USED IN PATIENT TREATMENT OR CONTRIBUTED TO AN ADVERSE EVENT. MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE ADDITIONAL INFORMATION, HOWEVER, A RESPONSE WAS NOT RECEIVED. THIS REPORT CAPTURES THE UNSPECIFIED NUMBER OF OCCURRENCE OF NATURALYTE LOW CONDUCTIVITY VALUES FOUND DURING TESTING. THE UNSPECIFIED DATES OF THESE OCCURRENCES WILL BE CAPTURED AS 01-NOV-2020.

  Patient problems: No Patient Involvement

  MAUDE report 10933373 ↗
• 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 VALUES. UPON FOLLOW UP, THE BIOMED REPORTED THAT DURING PATIENT USE, THE CONDUCTIVITY WAS AT 12.7 MS/CM. THE THEORETICAL CONDUCTIVITY PARAMETER ON THE MACHINE WAS NOT REPORTED. PER THE BIOMED, THEY SWITCHED TO NATURALYTE LOT#: 19NTAC083 IN THE MIDDLE OF TREATMENT. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. PER THE BIOMED, 8 CASES OF THE PRODUCT ARE AFFECTED. THE BIOMED REPORTED THAT THERE WAS NO SERVICE TO THE MACHINES, AND THAT THEY USE BICARBONATE NATURALYTE 4000RX12, LOT 20LTBC001. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10932816 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN(BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT NATURALYTE HAS LOW CONDUCTIVITY AND SPECIFIC GRAVITY. UPON FOLLOW UP, THE BIOMED REPORTED THAT BEFORE USE, THE CONDUCTIVITY WAS AT 13.0. NO PATIENTS WERE TREATED WITH THE LOT. PER THE BIOMED, 2 CASES ARE AFFECTED AND NOW THEY ARE USING NATURALYTE LOT 20KXAC099 WITHOUT ANY ISSUES. THE BIOMED REPORTED THAT THERE WAS NO SERVICE TO THE MACHINES AND THAT THEY USE BICARBONATE NATURALYTE 45X, LOT NUMBER 20LXBC010.

  Patient problems: No Patient Involvement

  MAUDE report 10928706 ↗
• 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 BEFORE USE, THE CONDUCTIVITY WAS 13.0. NO PATIENTS WERE TREATED WITH THESE LOTS. PER THE BIOMED, 24 CASES ARE AFFECTED AND NOW THEY ARE USING NATURALYTE LOT: 20LXAC086. THE BIOMED REPORTED THAT THERE WAS NO SERVICE TO THE MACHINES, AND THAT THEY USE BICARBONATE NATURALYTE 4000RX12, LOT NUMBER KNOW UNKNOWN. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Patient Involvement

  MAUDE report 10928461 ↗
• MalfunctionNov 30, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A BATCH OF NATURALYTE WAS RESULTING IN LOW CONDUCTIVITY DURING TREATMENT. THERE WAS NO REPORTED ADVERSE EVENT, SERIOUS INJURY, NOR REQUIRED MEDICAL INTERVENTION RELATED TO THE EVENT. UPON FOLLOW UP, THE BMT REPORTED THE PATIENT WAS SWITCHED TO ANOTHER LOT OF NATURALYTE MID-TREATMENT WITHOUT ANY ILL EFFECTS OR ADVERSE EVENTS. HE HAS NOT BEEN IN TOUCH WITH CUSTOMER SERVICE. THERE HAS NOT BEEN ANY RECENT SERVICE TO HIS MACHINES. THEY USE NATURALYTE BICARBONATE (PRODUCT AND LOT NUMBERS UNKNOWN). THERE WAS NO RECENT SERVICE TO THE MACHINE. THE BMT HAS NOT BEEN IN CONTACT WITH CUSTOMER SERVICE TO RETURN THE ALLEGED PRODUCT. A PICK UP WAS SCHEDULED FOR A SAMPLE OF THE REPORTED BATCH. THE CLINIC UTILIZES RX-12 NATURALYTE DRY BI-CARB OF UNKNOWN LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10919278 ↗
• MalfunctionNov 29, 2020Chemical Problem; Chemical Problem

  A DISTRIBUTOR COMPLAINT COORDINATOR REPORTED TO FRESENIUS CUSTOMER SERVICE ON BEHALF OF A HEMODIALYSIS (HD) CLINIC THAT A LOT OF NATURALYTE WAS PRODUCING LOW CONDUCTIVITY VALUES OF 0.5 MS/CM. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT, ADVERSE EVENTS, OR MEDICAL INTERVENTION RELATED TO THE REPORTED EVENT. IT IS UNKNOWN IF THE CONDUCTIVITY WAS OBSERVED DURING TREATMENT OR DURING SETUP. THE CLINIC HAS MADE ARRANGEMENTS TO RETURN A SAMPLE OF THE REPORTED PRODUCT. MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE ADDITIONAL INFORMATION, HOWEVER, A RESPONSE WAS NOT RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 10916316 ↗
• MalfunctionNov 29, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A BATCH OF NATURALYTE WAS RESULTING IN LOW CONDUCTIVITY DURING TESTING/SET-UP PRIOR TO INITIATING TREATMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE ARE A TOTAL OF 29 JUGS OF THE SAME BATCH WHICH THE CLINIC HAS REMOVED FROM STOCK AND WILL NOT BE USING. UPON FOLLOW UP, THE BMT CONFIRMED THE REPORTED EVENT. SHE SAID SHE WAS INFORMED THAT A MACHINE HAD LOW CONDUCTIVITY DURING SETUP WHILE USING A PARTICULAR BATCH OF NATURALYTE. SHE REPEATED THE TESTS AND CONFIRMED THE LOW CONDUCTIVITY. SHE DOES NOT RECALL THE CONDUCTIVITY VALUES BUT CLARIFIED THAT IT WAS NOT WITHIN THE ACCEPTABLE LIMITS TO INITIATE TREATMENT WITH THE BATCH. THE REMAINING 29 JUGS OF THE REPORTED BATCH WERE SEQUESTERED. SHE CONFIRMED NO PATIENTS WERE TREATED WITH THIS BATCH. THERE WAS NO SERVICE RECENTLY PERFORMED FOR THE MACHINES INVOLVED. THEY ARE USING NATURALYTE BICARB (PART AND LOT # UNKNOWN). A SAMPLE IS AVAILABLE TO RETURN. THE BMT WAS INFORMED A PICK UP WILL BE SCHEDULED FOR A SAMPLE RETURN.

  Patient problems: No Patient Involvement

  MAUDE report 10916198 ↗
• MalfunctionNov 25, 2020Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED VIA FAX THAT THE NATURALYTE IS GIVING LOW MACHINE CONDUCTIVITY. UPON FOLLOW UP, THE CUSTOMER SAID THAT DURING TREATMENT, THE CONDUCTIVITY WAS AT 12.9 AND TCD 13.5. THE PATIENT WAS SWITCHED TO A DIFFERENT LOT MID-TREATMENT WITHOUT ANY ILL EFFECTS OR ADVERSE EVENTS. PER THE BIOMED, 13 CASES ARE AFFECTED AND THAT THERE HAS NOT BEEN ANY RECENT SERVICE TO THE MACHINES. THEY CLINIC USES NATURALYTE DRY MIX BICARBONATE PRODUCT, LOT NUMBERS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10906844 ↗
• MalfunctionNov 25, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC PRODUCTS COORDINATOR REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. IT WAS REPORTED THAT 4 MACHINES WERE NOT RUNNING PROPERLY DURING PRETREATMENT SETUP AND AFTER DOING A TEST THEY REALIZED IT WAS NOT THE MACHINES BUT A SPECIFIC LOT NUMBER OF NATURALYTE. UPON FOLLOW UP, THE CUSTOMER SAID THAT DURING PATIENT TREATMENT, THE CONDUCTIVITY WAS AT 13-13.1 AND TCD 13.6 ON A FRESENIUS HD MACHINE, RESULTING IN A LOW CONDUCTIVITY ALARM. THE FRESENIUS HD MACHINE WAS SWAPPED OUT FOR A PHOENIX MACHINE, WHICH HAD NO CONDUCTIVITY ALARMS. THIS OCCURRED DURING A PATIENT'S TREATMENT. THE PATIENT COMPLETED TREATMENT WITH THE PRODUCT AND DID NOT EXPERIENCE ANY ILL EFFECTS OR ADVERSE EVENTS AND THAT IT WAS 4 JUGS THAT WERE AFFECTED. PER THE CLINIC, THEY HAVE USED NATURALYTE LOT 20NTAC054 WITHOUT ANY ISSUES AND THE MACHINES HAVE NOT HAVE ANY RECENT SERVICE. THE CLINIC USES BIBAGS WITH LOTS ENDING IN 2-7170 AND 2-6101. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10906798 ↗
• MalfunctionNov 25, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC PRODUCTS COORDINATOR REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. IT WAS REPORTED THAT 4 MACHINES WERE NOT RUNNING PROPERLY DURING PRETREATMENT SETUP AND AFTER DOING A TEST THEY REALIZED IT WAS NOT THE MACHINES BUT A SPECIFIC LOT NUMBER OF NATURALYTE. UPON FOLLOW UP, THE CUSTOMER SAID THAT DURING PATIENT TREATMENT, THE CONDUCTIVITY WAS AT 13-13.1 AND TCD 13.6 ON A FRESENIUS HD MACHINE, RESULTING IN A LOW CONDUCTIVITY ALARM. THE FRESENIUS HD MACHINE WAS SWAPPED OUT FOR A PHOENIX MACHINE, WHICH HAD NO CONDUCTIVITY ALARMS. THIS OCCURRED DURING A PATIENT'S TREATMENT. THE PATIENT COMPLETED TREATMENT WITH THE PRODUCT AND DID NOT EXPERIENCE ANY ILL EFFECTS OR ADVERSE EVENTS AND THAT IT WAS 4 JUGS THAT WERE AFFECTED. PER THE CLINIC, THEY HAVE USED NATURALYTE LOT 20NTAC054 WITHOUT ANY ISSUES AND THE MACHINES HAVE NOT HAVE ANY RECENT SERVICE. THE CLINIC USES BIBAGS WITH LOTS ENDING IN 2-7170 AND 2-6101. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10906794 ↗
• MalfunctionNov 25, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC PRODUCTS COORDINATOR REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. IT WAS REPORTED THAT 4 MACHINES WERE NOT RUNNING PROPERLY DURING PRETREATMENT SETUP AND AFTER DOING A TEST THEY REALIZED IT WAS NOT THE MACHINES BUT A SPECIFIC LOT NUMBER OF NATURALYTE. UPON FOLLOW UP, THE CUSTOMER SAID THAT DURING PATIENT TREATMENT, THE CONDUCTIVITY WAS AT 13-13.1 AND TCD 13.6 ON A FRESENIUS HD MACHINE, RESULTING IN A LOW CONDUCTIVITY ALARM. THE FRESENIUS HD MACHINE WAS SWAPPED OUT FOR A PHOENIX MACHINE, WHICH HAD NO CONDUCTIVITY ALARMS. THE PATIENT COMPLETED TREATMENT WITH THE PRODUCT AND DID NOT EXPERIENCE ANY ILL EFFECTS OR ADVERSE EVENTS AND THAT IT WAS 4 JUGS THAT WERE AFFECTED. PER THE CLINIC, THEY HAVE USED NATURALYTE LOT 20NTAC054 WITHOUT ANY ISSUES AND THE MACHINES HAVE NOT HAVE ANY RECENT SERVICE. THE CLINIC USES BIBAGS WITH LOTS ENDING IN 2-7170 AND 2-6101. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10906756 ↗
• MalfunctionNov 25, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC PRODUCTS COORDINATOR REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. IT WAS REPORTED THAT 4 MACHINES WERE NOT RUNNING PROPERLY DURING PRETREATMENT SETUP AND AFTER DOING A TEST THEY REALIZED IT WAS NOT THE MACHINES BUT A SPECIFIC LOT NUMBER OF NATURALYTE. UPON FOLLOW UP, THE CUSTOMER SAID THAT DURING PATIENT TREATMENT, THE CONDUCTIVITY WAS AT 13-13.1 AND TCD 13.6 ON A FRESENIUS HD MACHINE, RESULTING IN A LOW CONDUCTIVITY ALARM. THE FRESENIUS HD MACHINE WAS SWAPPED OUT FOR A PHOENIX MACHINE, WHICH HAD NO CONDUCTIVITY ALARMS. THIS OCCURRED DURING A PATIENT'S TREATMENT. THE PATIENT COMPLETED TREATMENT WITH THE PRODUCT AND DID NOT EXPERIENCE ANY ILL EFFECTS OR ADVERSE EVENTS AND THAT IT WAS 4 JUGS THAT WERE AFFECTED. PER THE CLINIC, THEY HAVE USED NATURALYTE LOT 20NTAC054 WITHOUT ANY ISSUES AND THE MACHINES HAVE NOT HAVE ANY RECENT SERVICE. THE CLINIC USES BIBAGS WITH LOTS ENDING IN 2-7170 AND 2-6101. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10906753 ↗
• MalfunctionNov 25, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE LOW A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. UPON FOLLOW UP, THE BIOMED STATED THAT BEFORE USE, THE CONDUCTIVITY WAS AT 13.0. THERE WERE NO PATIENTS THAT WERE TREATED WITH THIS LOT. PER THE BIOMED, THERE ARE 2 CASES THAT ARE AFFECTED. THEY CLINIC USED NATURALYTE BICARBONATE 45X, LOT NUMBER 20LXBC010. THERE HAS BEEN NO RECENT SERVICE TO THE MACHINES. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Patient Involvement

  MAUDE report 10906293 ↗
• MalfunctionNov 25, 2020Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED VIA EMAIL THAT THE NATURALYTE HAS LOW CONDUCTIVITY. UPON FOLLOW UP, THE BIOMED REPORTED THAT DURING TREATMENT, THE CONDUCTIVITY WAS AT 13.0. PER THE BIOMED, THE PATIENTS COMPLETED TREATMENT WITH THE LOT WITHOUT ANY ILL EFFECTS OR ADVERSE EVENTS. THE BIOMED REPORTED THAT 1 CASE IS AFFECTED AND THAT THEY DO NOT KNOW WHAT LOT THE CLINIC IS CURRENTLY USING. THE BIOMED STATED THAT THERE HAS NOT BEEN ANY SERVICE TO HIS MACHINES BESIDES PREVENTATIVE MAINTENANCE (PM) AND THAT THE CLINIC USES NATURALYTE BICARBONATE RX12, THE LOT NUMBER IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10906291 ↗
• MalfunctionNov 25, 2020Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED VIA EMAIL THAT THE NATURALYTE HAS LOW CONDUCTIVITY. UPON FOLLOW UP, THE BIOMED REPORTED THAT DURING TREATMENT, THE CONDUCTIVITY WAS AT 13.0. PER THE BIOMED, THE PATIENTS COMPLETED TREATMENT WITH THE LOT WITHOUT ANY ILL EFFECTS OR ADVERSE EVENTS. THE BIOMED REPORTED THAT 1 CASE IS AFFECTED AND THAT THEY DO NOT KNOW WHAT LOT THE CLINIC IS CURRENTLY USING. THE BIOMED STATED THAT THERE HAS NOT BEEN ANY SERVICE TO HIS MACHINES BESIDES PREVENTATIVE MAINTENANCE (PM) AND THAT THE CLINIC USES NATURALYTE BICARBONATE RX12, THE LOT NUMBER IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10906231 ↗
• MalfunctionNov 25, 2020Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED VIA FAX THAT THE MACHINES' CONDUCTIVITY WILL NOT GO ABOVE 13.0 WITH THE NATURALYTE. ONCE THE LOT NUMBER WAS CHANGED, THE MACHINE RAN AT 13.5. UPON FOLLOW UP, THE CUSTOMER SAID THAT DURING TREATMENT, THE CONDUCTIVITY WAS AT 12.9. THE PATIENT WAS SWITCHED TO ANOTHER LOT OF NATURALYTE TO COMPLETE TREATMENT WITHOUT ANY ILL EFFECTS OR ADVERSE EVENTS. PER THE BIOMED, 5 CASES ARE AFFECTED AND THAT THERE HAS NOT BEEN ANY RECENT SERVICE TO THE MACHINES. THE CLINIC USES NATURALYTE BICARBONATE 45X, LOT NUMBER IS UNKNOWN. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10906209 ↗