NaturaLyte 08-2251-0Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00840861101696), received between Nov 25, 2020 and Apr 7, 2021 — classified as 1 death, 19 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (20 reports).

3 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. Apr 28, 2021Terminated

   Exposed to freezing temperatures due to refrigerated truck malfunctions

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

3. Sep 29, 2017Terminated

   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 problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 10933253 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC¿S AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY HAVE FEW CASES OF NATURALYTE WITH LOW CONDUCTIVITY DETECTED DURING SETUP. UPON FOLLOW UP, THE ATOM REPORTED THAT BEFORE TREATMENT, THE CONDUCTIVITY WAS AT 12.8.MS/CM. THE PARAMETERS FOR THE THEORETICAL CONDUCTIVITY VALUE PROGRAMMED INTO THE MACHINE WERE NOT PROVIDED. THE ATOM CONFIRMED NO PATIENTS WERE TREATED WITH THIS LOT. PER THE ATOM 24 CASES ARE AFFECTED. THE ATOM DOES NOT KNOW THE LOT NUMBER OF NATURALYTE THAT THEY WERE CURRENTLY USING. THERE WAS NO RECENT SERVICE ON THE MACHINE. THE CLINIC IS USING BIBAG 4000RX12 BICARBONATE (LOT NUMBER UNKNOWN). NO SAMPLE IS EXPECTED TO RETURN FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 10932808 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, ADVERSE EVENT, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS REPORTED EVENT. MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE ADDITIONAL INFORMATION, HOWEVER, A RESPONSE WAS NOT RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 10932713 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC DIRECTOR OF OPERATIONS REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY VALUES ON THE HD MACHINE. PER THE DIRECTOR OF OPERATIONS, THE CONDUCTIVITY WAS 13.3 MS/CM. THE THEORETICAL CONDUCTIVITY VALUE WAS NOT REPORTED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, ADVERSE EVENT, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, A RESPONSE WAS NOT RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 10932637 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC MANAGER REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. UPON FOLLOW UP, THE MANAGER REPORTED THAT BEFORE USE, THE CONDUCTIVITY WAS AT 13.3 TO 13.2. PER THE MANAGER, 15 CASES ARE AFFECTED. THE MANAGER 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 10929469 ↗
• 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. UPON FOLLOW UP, THE BIOMED REPORTED THAT DURING USE, THE CONDUCTIVITY WAS AT 10.9. THE PATIENT COMPLETED THE TREATMENT USING THIS PRODUCT. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION. PER THE BIOMED, 20 CASES ARE AFFECTED, AND NOW THEY ARE USING NATURALYTE LOT 20LXAC016 WITHOUT ANY ISSUES. 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 10928809 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED VIA FAX THAT THE NATURALYTE HAD LOW CONDUCTIVITY. THE BIOMED REPORTED THAT THE CONDUCTIVITY WOULD NOT GO ABOVE 13.1. THE BIOMED STATED THAT THE ISSUE WAS DISCOVERED BEFORE USE AND THE CONDUCTIVITY WAS AT 12.9. THE BIOMED REPORTED THAT 4 JUGS OF 20LXAC101 WERE SET ASIDE. NO PATIENTS WERE TREATED WITH THIS LOTS. THE LOT NUMBER FOR THE NATURALYTE THAT IS CURRENTLY BEING USED WAS NOT PROVIDED. THE BIOMED STATED THAT THERE HAS NOT BEEN ANY SERVICE TO THEIR MACHINES BESIDES PREVENTATIVE MAINTENANCE (PM) AND THAT THE CLINIC USES BIBAGS FOR BICARBONATE THE LOT NUMBER IS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 10928284 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED VIA FAX THAT THE NATURALYTE HAD LOW CONDUCTIVITY. THE BIOMED REPORTED THAT THE CONDUCTIVITY WOULD NOT GO ABOVE 13.1. UPON FOLLOW UP, THE BIOMED REPORTED THAT THE ISSUE WAS DISCOVERED BEFORE USE AND THE CONDUCTIVITY WAS AT 12.9. THE BIOMED REPORTED THAT 30 JUGS OF THIS LOT NUMBER WERE SET ASIDE. NO PATIENTS WERE TREATED WITH THIS LOT NUMBER. THE LOT NUMBER FOR THE NATURALYTE THAT IS CURRENTLY BEING USED WAS NOT PROVIDED. THE BIOMED STATED THAT THERE HAS NOT BEEN ANY SERVICE TO THEIR MACHINES BESIDES PREVENTATIVE MAINTENANCE (PM) AND THAT THE CLINIC USES BIBAGS FOR BICARBONATE THE LOT NUMBER IS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 10928277 ↗
• 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. PER THE BIOMED THE CONDUCTIVITY WILL NOT GO PAST 13.2. ONCE THE PRODUCT WAS SWITCHED TO A NEW LOT, THE CONDUCTIVITY RAISED TO 13.6. THE EVENT OCCURRED DURING PATIENT TREATMENT AND THE CONDUCTIVITY WAS RUNNING LOW ON 13.2. UPON FOLLOW UP, THE BIOMED REPORTED THAT THE TCD WAS SET FOR 13.5 OR 13.6 ON A FRESENIUS 2008T BLUE STAR MACHINE. THE PRODUCT WAS ONLY USED FOR ONE PATIENT TREATMENT, ALTHOUGH 16 JUGS WERE AFFECTED. THE PATIENT WAS SWITCHED ANOTHER JUG TO COMPLETE TREATMENT. THE PATIENT DID NOT EXPERIENCE ANY ILL EFFECTS, ADVERSE EVENTS, OR REQUIRE MEDICAL INTERVENTION. PER THE BIOMED, IT IS UNKNOWN WHAT LOT OF NATURALYTE WAS USED SUCCESSFULLY AND THAT THERE HAS NOT BEEN ANY RECENT SERVICE TO THE MACHINES. THE CLINIC IS USING LIQUID BICARBONATE, LOT NUMBER 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 10927220 ↗
• 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 DURING TESTING. PER THE BIOMED THE CONDUCTIVITY WILL NOT GO PAST 13.2. ONCE THE PRODUCT WAS SWITCHED TO A NEW LOT, THE CONDUCTIVITY RAISED TO 13.6. THE CLINIC IS USING LIQUID BICARBONATE, LOT NUMBER UNKNOWN, AND 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 Known Impact Or Consequence To Patient

  MAUDE report 10927216 ↗
• MalfunctionNov 30, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A LOT OF NATURALYTE HAD LOW CONDUCTIVITY. UPON FOLLOW UP, THE ATOM REPORTED THAT BEFORE USE, THE CONDUCTIVITY WAS AT 13.1MS/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. THE ATOM STATED THEY USED ONE JUG FROM THE LOT, HOWEVER THEY HAD EIGHT AND A HALF CASES THAT WOULD NOT BE USED. THE ATOM REPORTED THAT THEY USE BIBAGS FOR BICARBONATE. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Patient Involvement

  MAUDE report 10924330 ↗
• 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 TREATMENT. THERE WAS NO REPORTED ADVERSE EVENT, SERIOUS INJURY, NOR REQUIRED MEDICAL INTERVENTION RELATED TO THE EVENT. UPON FOLLOW UP, THE BMT REPORTED THAT DURING TREATMENT THE CONDUCTIVITY WAS AT 13.5 MS/CM ALTHOUGH THE THEORETICAL CONDUCTIVITY VALUE (TCD) WAS SET TO 14.1 MS/CM. THE PATIENT WAS SWITCHED TO ANOTHER LOT OF NATURALYTE MID-TREATMENT WITHOUT ANY ILL EFFECTS OR ADVERSE EVENTS. 20 CASES OF 3251 AND 10 CASES OF 2251 ARE AFFECTED. THE BMT PREVIOUSLY SCHEDULED A PICK UP FOR THE REMAINING CASES SO THEY CAN BE RETURNED TO THE MANUFACTURER. THERE HAS NOT BEEN ANY RECENT SERVICE TO THE MACHINE. THEY USE BIBAG BICARBONATE LOT 20JK01011.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10916194 ↗
• 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 TREATMENT. THERE WAS NO REPORTED ADVERSE EVENT, SERIOUS INJURY, NOR REQUIRED MEDICAL INTERVENTION RELATED TO THE EVENT. UPON FOLLOW UP, THE BMT REPORTED THAT DURING TREATMENT THE CONDUCTIVITY WAS AT 13.5 MS/CM ALTHOUGH THE THEORETICAL CONDUCTIVITY VALUE (TCD) WAS SET TO 14.1 MS/CM. THE PATIENT WAS SWITCHED TO ANOTHER LOT OF NATURALYTE MID-TREATMENT WITHOUT ANY ILL EFFECTS OR ADVERSE EVENTS. 20 CASES OF 3251 AND 10 CASES OF 2251 ARE AFFECTED. THE BMT PREVIOUSLY SCHEDULED A PICK UP FOR THE REMAINING CASES SO THEY CAN BE RETURNED TO THE MANUFACTURER. THERE HAS NOT BEEN ANY RECENT SERVICE TO THE MACHINE. THEY USE BIBAG BICARBONATE LOT 20JK01011.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10916193 ↗
• MalfunctionNov 29, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT A THREE BATCHES OF NATURALYTE WERE RESULTING IN LOW CONDUCTIVITY DURING TESTING/SET-UP PRIOR TO INITIATING TREATMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. UPON FOLLOW UP, THE BMT REPORTED DURING SETUP THE CONDUCTIVITY WAS AT 13.2 MS/CM ALTHOUGH THE THEORETICAL CONDUCTIVITY VALUE (TCD) WAS SET TO 13.6 MS/CM. HE CONFIRMED NO PATIENTS WERE TREATED WITH THIS BATCH. THERE WAS NO RECENT SERVICE TO THE MACHINE. THERE WERE A TOTAL OF 2 CASES OF EACH REPORTED LOT, HOWEVER, THEY WERE DISCARDED. THE HD CLINIC IS UTILIZING BIBAGS FOR BICARBONATE (UNKNOWN PRODUCT AND LOT NUMBERS).

  Patient problems: No Patient Involvement

  MAUDE report 10916191 ↗
• MalfunctionNov 25, 2020Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED VIA EMAIL THAT THE FINAL CONDUCTIVITY WAS 0.4 TO 0.5 LESS THAN TCD WHICH PUT CONDUCTIVITY AT A LOWER LIMIT OR BELOW. THE BIOMED REPORTED THAT MULTIPLE MACHINES WERE CHECKED WITH A KNOWN GOOD CONCENTRATE, SAME PRODUCT BUT DIFFERENT LOT NUMBER, AND THE CONDUCTIVITY WAS WITHIN 0.15 TO 0.10 OF THE TCD. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER TO DATE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10906965 ↗
• MalfunctionNov 25, 2020Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED VIA EMAIL THAT THE FINAL CONDUCTIVITY WAS 0.4 TO 0.5 LESS THAN TCD WHICH PUT CONDUCTIVITY AT A LOWER LIMIT OR BELOW. THE BIOMED REPORTED THAT MULTIPLE MACHINES WERE CHECKED WITH A KNOWN GOOD CONCENTRATE, SAME PRODUCT BUT DIFFERENT LOT NUMBER, AND THE CONDUCTIVITY WAS WITHIN 0.15 TO 0.10 OF THE TCD. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER TO DATE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10906679 ↗