NaturaLyte 08-3251-9Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00840861101740), received between Nov 25, 2020 and Mar 26, 2021 — classified as 78 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (78 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 18, 2026.

Recalls naming this device

1. Jul 14, 2026Class IIOpen, Classified

   Complaints of blue-green discoloration in product

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

2. Apr 28, 2021Class IITerminated

   Exposed to freezing temperatures due to refrigerated truck malfunctions

   Z-2086-2021 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.

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

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY HAD A NATURALYTE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES. UPON FOLLOW UP THE REGISTERED NURSE (RN) CONFIRMED THE REPORTED EVENT AND REPORTED THAT THE INCIDENT OCCURRED WITH AN UNSPECIFIED NUMBER OF MACHINES ON UNKNOWN DATES. SHE CONFIRMED THAT IN ALL CASES WHERE THEY EXPERIENCED CONDUCTIVITY ISSUES DURING TREATMENT, ALL THE PATIENTS WERE ABLE TO COMPLETE THEIR TREATMENT AFTER SWITCHING THE JUGS OF NATURALYTE MID-TREATMENT. THERE WERE NO ADVERSE EVENTS, SERIOUS INJURIES, NOR REQUIRED MEDICAL INTERVENTION AS A RESULT OF THESE EVENTS. THEY ARE CURRENTLY USING BIBAGS BI-CARB. SAMPLE RETURN PICKUP WAS SCHEDULED. THIS RECORD CAPTURES ALL OF THE CLINICS UNSPECIFIED NUMBER OF INCIDENTS OF LOW CONDUCTIVITY EXPERIENCED DURING TREATMENT WHILE UTILIZING THE REPORTED BATCH. THE EVENT DATE FOR THE MULTIPLE OCCURRENCES WILL BE CAPTURES AS (B)(6) 2020.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10933337 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY RECEIVED LOW CONDUCTIVITY VALUES FROM NATURALYTE DURING SETUP FOR HD TREATMENT. UPON FOLLOW UP WITH THE BMT IT WAS CONFIRMED THAT THE LOW CONDUCTIVITY VALUES WERE RECEIVED DURING TESTING OF NATURALYTE PRIOR TO PATIENT USE. THE THEORETICAL CONDUCTIVITY VALUES WERE SET TO 13.7 MS/CM AND THE ACTUAL CONDUCTIVITY VALUE WAS 13.3 MS/CM. THE CLINIC REVERTED TO USING AN UNKNOWN BATCH OF NATURALYTE THAT DID NOT HAVE LOW CONDUCTIVITY ISSUES. THERE ARE STILL CASES AVAILABLE FOR RETURN. A PICKUP WAS SCHEDULED TO RETURN SAMPLES. THE CLINIC IS CURRENTLY USING MEDAVATORS BICARB (PART AND LOT # ARE UNKNOWN).

  Patient problems: No Patient Involvement

  MAUDE report 10933306 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY RECEIVED LOW CONDUCTIVITY VALUES FROM NATURALYTE DURING SETUP FOR HD TREATMENT. UPON FOLLOW UP WITH THE BMT IT WAS CONFIRMED THAT THE LOW CONDUCTIVITY VALUES WERE RECEIVED DURING TESTING OF NATURALYTE PRIOR TO PATIENT USE. THE THEORETICAL CONDUCTIVITY VALUES WERE SET TO 13.7 MS/CM AND THE ACTUAL CONDUCTIVITY VALUE WAS 13.3 MS/CM. THE CLINIC REVERTED TO USING AN UNKNOWN BATCH OF NATURALYTE THAT DID NOT HAVE LOW CONDUCTIVITY ISSUES. THERE ARE STILL CASES AVAILABLE FOR RETURN. A PICKUP WAS SCHEDULED TO RETURN SAMPLES. THE CLINIC IS CURRENTLY USING MEDAVATORS BICARB (PART AND LOT # ARE UNKNOWN).

  Patient problems: No Patient Involvement

  MAUDE report 10933219 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A (B)(6) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED A LOT OF NATURALYTE WHICH HAD LOW CONDUCTIVITY VALUES DURING TREATMENT. UPON FOLLOW UP, THE BIOMED INDICATED THAT THE ACTUAL CONDUCTIVITY VALUE WAS NOT CAPTURED, HOWEVER, THE VALUE WAS DETERMINED TO BE LOW ENOUGH TO PROMPT THE CLINIC TO SWITCH OUT THE NATURALYTE MID 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, 2 JUGS OF THE PRODUCT ARE AFFECTED. THE BIOMED REPORTED THAT THERE WAS NO SERVICE TO THE MACHINES AND THAT THEY USE BICARBONATE NATURALYTE RX12, LOT 20HXBC011. NO SAMPLE WAS RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10932730 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY RECEIVED LOW CONDUCTIVITY VALUES FROM A SPECIFIC NATURALYTE BATCH ON MULTIPLE HD MACHINES. IT WAS NOT SPECIFIED IF THE MACHINES WERE BEING USED FOR TREATMENT OR WERE BEING SETUP WHEN THE LOW CONDUCTIVITY WAS DETECTED. ADDITIONALLY, THERE WAS NO INFORMATION REPORTED ON THE NUMBER OF OCCURRENCES AND THE DATES. THERE WAS NO REPORTED ADVERSE EVENT, OR SERIOUS INJURY ATTRIBUTED TO THE ALLEGATION. THE UNKNOWN DATE OF EVENT WILL BE CAPTURED AS (B)(6) 2020.

  Patient problems: No Patient Involvement

  MAUDE report 10932710 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY RECEIVED LOW CONDUCTIVITY VALUES FROM A SPECIFIC NATURALYTE BATCH ON AN HD MACHINE. IT WAS NOT SPECIFIED IF THE MACHINE WAS BEING USED FOR TREATMENT OR WAS BEING SETUP WHEN THE LOW CONDUCTIVITY WAS DETECTED. THE MACHINE ALARMED FOR THE LOW CONDUCTIVITY. ADDITIONALLY, THERE WAS NO INFORMATION REPORTED ON THE NUMBER OF OCCURRENCES OF THESE ALARMS AND THE DATES. THERE WAS NO REPORTED ADVERSE EVENT OR SERIOUS INJURY ATTRIBUTED TO THE ALLEGATION. MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE ADDITIONAL INFORMATION; HOWEVER, A RESPONSE WAS NOT RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 10932638 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT THEY RECEIVED LOW CONDUCTIVITY VALUES FROM NATURALYTE DURING SETUP FOR HD TREATMENT . UPON FOLLOW UP WITH THE BMT IT WAS REPORTED THE LOW CONDUCTIVITY WAS FOUND DURING SETUP AND PRIOR TO PATIENT USE. THE ACTUAL CONDUCTIVITY VALUE WAS 13.1 MS/CM. THE BMT BELIEVES THE THEORETICAL CONDUCTIVITY VALUE WAS SET TO 13.5. THE PRODUCT WAS NOT USED DURING PATIENT TREATMENT BECAUSE THEY WERE SWITCHED TO GRANUFLO. THERE ARE STILL CASES AVAILABLE. A PICKUP WAS SCHEDULED TO RETURN SAMPLES. THE BICARB USED WAS BIBAGS, LOT NUMBER UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 10932634 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY RECEIVED LOW CONDUCTIVITY FROM NATURALYTE DURING SETUP FOR HD TREATMENT ON AN UNSPECIFIED NUMBER OF MACHINES. UPON FOLLOW UP THE BMT WAS UNABLE TO IDENTIFY THE NUMBER OF MACHINES THAT HAD LOW CONDUCTIVITY RESULTS WITH NATURALYTE. HE CONFIRMED THE PRODUCT WAS NOT USED DURING PATIENT TREATMENT BECAUSE THEY WERE SWITCHED TO GRANUFLO. THERE ARE STILL CASES OF THE REPORTED LOT AVAILABLE. A PICKUP WAS SCHEDULED TO RETURN SAMPLES. THE BICARB USED WAS BIBAGS, LOT NUMBER UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 10932624 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT THEY RECEIVED LOW CONDUCTIVITY VALUES FROM NATURALYTE DURING SETUP FOR HD TREATMENT . UPON FOLLOW UP WITH THE BMT IT WAS REPORTED THE LOW CONDUCTIVITY WAS FOUND DURING SETUP AND PRIOR TO PATIENT USE. THE ACTUAL CONDUCTIVITY VALUE WAS 13.1 MS/CM. THE BMT BELIEVES THE THEORETICAL CONDUCTIVITY VALUE WAS SET TO 13.5. THE PRODUCT WAS NOT USED DURING PATIENT TREATMENT BECAUSE THEY WERE SWITCHED TO GRANUFLO. THERE ARE STILL CASES AVAILABLE. A PICKUP WAS SCHEDULED TO RETURN SAMPLES. THE BICARB USED WAS BIBAGS, LOT NUMBER UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 10932613 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY RECEIVED LOW CONDUCTIVITY FROM NATURALYTE DURING SETUP FOR HD TREATMENT ON AN UNSPECIFIED NUMBER OF MACHINES. UPON FOLLOW UP THE BMT WAS UNABLE TO IDENTIFY THE NUMBER OF MACHINES THAT HAD LOW CONDUCTIVITY RESULTS WITH NATURALYTE. HE CONFIRMED THE PRODUCT WAS NOT USED DURING PATIENT TREATMENT BECAUSE THEY WERE SWITCHED TO GRANUFLO. THERE ARE STILL CASES OF THE REPORTED LOT AVAILABLE. A PICKUP WAS SCHEDULED TO RETURN SAMPLES. THE BICARB USED WAS BIBAGS, LOT NUMBER UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 10932569 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A (B)(6) 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NO RESPONSES HAVE BEEN RECEIVED. MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE ADDITIONAL INFORMATION, HOWEVER, A RESPONSE WAS NOT RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10932152 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. THE MACHINE ALARMED LOW CONDUCTIVITY. UPON FOLLOW UP, THE CUSTOMER SAID THAT BEFORE USED THE CONDUCTIVITY WAS AT 13.1. PATIENTS WERE TREATED WITH THIS LOT. NO PATIENTS EXPERIENCED ANY ADVERSE EVENTS OR ILL EFFECTS. THE BIOMED STATED THEY DID NOT KNOW HOW MUCH PRODUCT THEY HAVE SET ASIDE. THERE HAS BEEN NO RECENT SERVICE TO THE MACHINES. THEY USE BIBAG 4000RX12 LOT NUMBER UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10931553 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TECHNICAL SUPPORT THAT THE 2008T MACHINE EXPERIENCED LOW CONDUCTIVITY. UPON FOLLOW UP, THE BIOMED CONFIRMED THAT THE MACHINE WAS RETURNED TO SERVICE WITHOUT ANY REPAIRS. THE BIOMED REPORTED THAT THEY EXPERIENCED LOW CONDUCTIVITY WHILE USING NATURALYTE, LOT 20LXAC059. THE BIOMED REPORTED THAT BEFORE USE, THE CONDUCTIVITY WAS AT 12.9. THE PATIENTS THAT WERE TREATED WITH THE LOT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. PER THE BIOMED 9 CASES OF THE PRODUCT ARE AFFECTED AND NOW THEY ARE USING NATURALYTE LOT 20LXAC079 WITHOUT ANY ISSUES. THE BIOMED REPORTED THAT THERE WAS NO SERVICE TO THE MACHINES A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10931428 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TECHNICAL SUPPORT THAT THE 2008T MACHINE EXPERIENCED LOW CONDUCTIVITY. UPON FOLLOW UP, THE BIOMED CONFIRMED THAT THE MACHINE WAS RETURNED TO SERVICE WITHOUT ANY REPAIRS. THE BIOMED REPORTED THAT THEY EXPERIENCED LOW CONDUCTIVITY WHILE USING NATURALYTE, LOT 20LXAC059. THE BIOMED REPORTED THAT BEFORE USE, THE CONDUCTIVITY WAS AT 12.9. THE PATIENTS THAT WERE TREATED WITH THE LOT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. PER THE BIOMED 9 CASES OF THE PRODUCT ARE AFFECTED AND NOW THEY ARE USING NATURALYTE LOT 20LXAC079 WITHOUT ANY ISSUES. THE BIOMED REPORTED THAT THERE WAS NO SERVICE TO THE MACHINES A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10931230 ↗
• 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 THE CONDUCTIVITY WAS AT 13.4. PER THE BIOMED, 6 CASES OF THE PRODUCT ARE AFFECTED. THE BIOMED REPORTED THAT SOME OF THE PRODUCT WAS USED FOR PATIENT TREATMENT. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED 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 10929610 ↗
• 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 10.5 MS/CM. THE PRODUCT WAS USED FOR PATIENT TREATMENT. THE PATIENT WAS CHANGED TO NATURALYTE LOT OFD3231-3B MID-TREATMENT AND COMPLETED TREATMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. PER THE BIOMED SIX CASES OF NATURALYTE WERE AFFECTED. THE BIOMED REPORTED THAT THERE WAS NO SERVICE TO THE MACHINES AND THAT THEY USE BICARBONATE NATURALYTE BAG LOT NUMBER 20KXBC006E. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10929140 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) AREA TECHNICAL OPERATIONS MANAGER REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. UPON FOLLOW UP, THE CUSTOMER REPORTED THAT BEFORE USE, THE CONDUCTIVITY WAS AT 13.4. NO PATIENTS WERE TREATED WITH THE LOT. PER THE CUSTOMER, 6 CASES ARE AFFECTED. THE CUSTOMER REPORTED THAT THERE WAS NO SERVICE TO THE MACHINES AND THAT THEY USE BICARBONATE NATURALYTE, 4000RX12, LOT NUMBER UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 10929087 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. UPON FOLLOW UP, THE CUSTOMER SAID THAT BEFORE USED THE CONDUCTIVITY WAS AT 13.1. PATIENTS WERE TREATED WITH THIS LOT. NO PATIENTS EXPERIENCED ANY ADVERSE EVENTS OR ILL EFFECTS. THE BIOMED STATED THEY DID NOT KNOW HOW MUCH PRODUCT THEY HAVE SET ASIDE. THERE HAS BEEN NO RECENT SERVICE TO THE MACHINES. THEY USED THE BIBAG 4000RX12; LOT NUMBER: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10928584 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  THE CLINIC'S AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED THAT THE CONDUCTIVITY IS BOUNCING OFF THE LOW ALARM LIMIT WHILE USING NATURALYTE. UPON FOLLOW UP, THE CUSTOMER SAID THAT DURING PATIENT USE, THE CONDUCTIVITY WAS AT 13.5, 13.6, AND TCD WAS AT 14.0. THE PATIENT WAS SWITCHED TO ANOTHER LOT OF NATURALYTE MID-TREATMENT WITH NO ADVERSE EVENTS OR ILL EFFECTS. PER THE ATOM, 10 CASES ARE AFFECTED AND DOES NOT KNOW WHAT LOT OF NATURALYTE THE CLINIC IS CURRENTLY USING. PER THE ATOM, THERE HAS NOT BEEN ANY RECENT SERVICE TO THE MACHINES AND THAT THEY USE BIBAG BICARBONATE, LOT NUMBER UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10927226 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED BY FAX THAT SOME NATURALYTE WOULD NOT COME UP TO CONDUCTIVITY. UPON FOLLOW UP, THE CUSTOMER SAID THAT BEFORE USE, THE CONDUCTIVITY WAS AT 10.6 MS/CM. THE BIOMED STATED THAT 20 GALLONS ARE EFFECTED. THE PRODUCT WAS NOT USED FOR PATIENT TREATMENT. THE BIOMED REPORTED THAT THERE WAS NO RECENT SERVICE TO ANY OF THE MACHINES. THE FACILITY WAS USING NATURALYTE BICARBONATE (LOT 20KXBC006). THE CUSTOMER HAS NOT BEEN IN TOUCH WITH CUSTOMER SERVICE TO OBTAIN A RETURNS GOOD AUTHORIZATION (RGA) FOR PRODUCT RETURN.

  Patient problems: No Patient Involvement

  MAUDE report 10927219 ↗