Citrasate 08-3251-CARecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00840861101351), received between Nov 25, 2020 and Apr 5, 2021 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Chemical Problem” (21 reports).

1 FDA recall record 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-3093-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2021Chemical Problem; Chemical Problem

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A BATCH OF CITRASATE ACID CONCENTRATE WAS NOT ACHIEVING THE DESIRED CONDUCTIVITY. UPON FOLLOW UP, THE BMT INDICATED THEY WERE NOT SURE IF THE LOW CONDUCTIVITY WAS OBSERVED DURING SETUP OR TREATMENT. HE CONFIRMED THE UNSPECIFIED HEMODIALYSIS (HD) MACHINE ALARMED APPROPRIATELY. THE BMT DOES NOT RECALL THE EXACT CONDUCTIVITY LEVELS THAT WERE OBSERVED. IT WAS INDICATED THERE WAS NO ADVERSE EVENT, SERIOUS INJURY, NOR REQUIRED MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE REMAINING JUGS OF THE REPORTED LOT WERE SEQUESTERED AND FRESENIUS CUSTOMER SERVICE SCHEDULED TO RETURN THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11617045 ↗
• MalfunctionFeb 3, 2021Chemical Problem; Chemical Problem

  A REGISTERED NURSE RN REPORTED THAT A 2008T MACHINE SHOWED LOW CONDUCTIVITY LEVELS WHEN USING A 3K CITRASATE ACID CONCENTRATE DURING HEMODIALYSIS (HD) TREATMENT. THE CONDUCTIVITY VALUES OBSERVED DURING TREATMENT WERE NOT REPORTED. IT WAS CONFIRMED THERE WAS NO ADVERSE EVENT, SERIOUS INJURY, NOR MEDICAL INTERVENTION REQUIRED DUE TO THIS EVENT. IT WAS REPORTED THAT OTHER MACHINES THAT USED JUGS FROM THE SAME BOX DID NOT EXPERIENCE THE REPORTED CONDUCTIVITY ISSUE. HE INDICATED THAT THE MACHINE INVOLVED IN THE EVENT HAD LOW CONDUCTIVITY RESULTS WITH JUGS FROM DIFFERENT BOXES. THE RN INDICATED HE SUSPECTS THE CAUSE OF THE REPORTED ISSUES IS THE MACHINE AND NOT THE PRODUCTS. MULTIPLE ATTEMPTS WERE MADE TO REACH THE BMT, BUT NOT RESPONSE WAS RECEIVED.

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

  MAUDE report 11276612 ↗
• MalfunctionFeb 3, 2021Chemical Problem; Chemical Problem

  A BIOMEDICAL TECHNICIAN REPORTED TO TECHNICAL SUPPORT THAT A 2008T MACHINE SHOWED LOW CONDUCTIVITY LEVELS WHEN USING A 3K CITRASATE ACID CONCENTRATE DURING SETUP FOR HEMODIALYSIS (HD) TREATMENT. THE ACTUAL CONDUCTIVITY LEVELS WERE 12.9 - 13.0 MS/CM WITH THE THEORETICAL CONDUCTIVITY VALUE OF 13.5 MS/CM. THERE WAS NO PATIENT INVOLVEMENT. UPON FOLLOW UP WITH A USER FACILITY REGISTERED NURSE (RN) IT WAS REPORTED THAT OTHER MACHINES THAT USED JUGS FROM THE SAME BOX DID NOT EXPERIENCE THE REPORTED CONDUCTIVITY ISSUE. HE INDICATED THAT THE MACHINE INVOLVED IN THE EVENT HAD LOW CONDUCTIVITY RESULTS WITH JUGS FROM DIFFERENT BOXES. THE RN INDICATED HE SUSPECTS THE CAUSE OF THE REPORTED ISSUES IS THE MACHINE AND NOT THE PRODUCTS. MULTIPLE ATTEMPTS WERE MADE TO REACH THE BMT, BUT NOT RESPONSE WAS RECEIVED.

  Patient problems: No Patient Involvement

  MAUDE report 11276610 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931549 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931541 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931529 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931523 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT, AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931522 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT, AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931519 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931517 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931515 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC, WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931506 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931479 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931478 ↗
• MalfunctionDec 2, 2020Chemical Problem; Chemical Problem

  A FACILITY BIOMEDICAL TECHNICIAN (BIOMED) FOR A HEMODIALYSIS (HD) USER FACILITY WAS NOTIFIED BY THE FACILITY THAT THEY USED A CITRASATE CONCENTRATE LOT THAT RESULTED IN LOW CONDUCTIVITY VALUES DURING SETUP OF THE HD MACHINE. THE ACTUAL CONDUCTIVITY VALUES FORM THE CITRASATE AND THE THEORETICAL CONDUCTIVITY VALUES PROGRAMMED IN THE MACHINE WERE NOT REPORTED. WHEN THEY USED A DIFFERENT CONCENTRATE LOT, THE CONDUCTIVITY VALUE FELL WITHIN THE ACCEPTABLE RANGE. THE BIOMED CONFIRMED THAT THIS OCCURRED PRIOR TO TREATMENT AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE 26 CASES OF THE REPORTED CITRASATE LOT AT THE CLINIC WHICH WERE RETURNED TO THE MANUFACTURER.

  Patient problems: No Patient Involvement

  MAUDE report 10931476 ↗
• MalfunctionDec 1, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY RECEIVED AN HD MACHINE ALARM FOR LOW CONDUCTIVITY VALUES FROM CITRASATE DURING TESTING OF AN HD MACHINE. UPON FOLLOW UP, THE BMT REPORTED THAT HE WAS CALLED IN TO SERVICE MACHINES AT THE CLINIC. WHILE TESTING THE BATCH OF CITRASATE THE CONDUCTIVITY VALUE WAS AT 13.2 MS/CM ALTHOUGH THE THEORETICAL CONDUCTIVITY VALUE (TCD) WAS SET TO 13.7 MS/CM. THE BMT CONFIRMED THIS TEST WAS TO DETERMINE THE CAUSE OF PREVIOUS CONDUCTIVITY ISSUES; THE MACHINE WAS NOT BEING SETUP FOR TREATMENT. ALL REMAINING CASES OF THE REPORTED BATCH WERE PICKED UP BY FRESENIUS CUSTOMER SERVICE. THE CLINIC IS CURRENTLY USING NATURALYTE DRY BI-CARB LOT 20LXBC007.

  Patient problems: No Patient Involvement

  MAUDE report 10931269 ↗
• MalfunctionNov 29, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BMT) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THEY RECEIVED AN HD MACHINE ALARM FOR LOW CONDUCTIVITY VALUES FROM CITRASATE DURING A PATIENT¿S TREATMENT. UPON FOLLOW UP, THE BMT REPORTED THAT DURING ONE PATIENT¿S HD TREATMENT, THE HD MACHINE ALARMED FOR LOW CONDUCTIVITY AND RESULTED IN AN EXTRA HOUR OF TREATMENT TIME. THE THEORETICAL AND ACTUAL CONDUCTIVITY VALUES ARE NOT AVAILABLE. THE BMT INDICATED THAT THERE WAS NO INFORMATION CAPTURED FOR THE PATIENT THAT EXPERIENCED THIS ISSUE BECAUSE THE PATIENT WAS ABLE TO COMPLETE THEIR TREATMENT WITH THE SAME CITRASATE BATCH AFTER ADJUSTING THE CONDUCTIVITY LIMITS ON THE MACHINE. THERE WERE NO ADVERSE EVENTS, SERIOUS INJURY, NOR REQUIRED MEDICAL INTERVENTION. ALL REMAINING CASES OF THE REPORTED BATCH WERE PICKED UP BY FRESENIUS CUSTOMER SERVICE. THE CLINIC IS CURRENTLY USING NATURALYTE DRY BI-CARB LOT 20LXBC007.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10916323 ↗
• MalfunctionNov 27, 2020Chemical Problem; Chemical Problem

  A BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THEY EXPERIENCED LOW CONDUCTIVITY WHEN USING LOT NUMBER 20LXAC051. PER THE BIOMED, DURING TREATMENT THE CONDUCTIVITY WAS AT 12.9 AND THE PATIENTS WERE SWITCHED MID-TREATMENT TO ANOTHER LOT OF NATURALYTE WITHOUT ANY ILL EFFECTS OR ADVERSE EVENTS. THE BIOMED DOES NOT KNOW WHAT LOT THE PATIENTS WERE SWITCHED TO. THE CLINIC USES NATURALYTE BICARBONATE, TYPE AND LOT UNKNOWN. PER THE BIOMED, 4 CASES ARE AFFECTED AND THERE HAS NOT BEEN ANY RECENT SERVICE TO THE MACHINES THAT WOULD AFFECT THE CONDUCTIVITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10913707 ↗
• MalfunctionNov 27, 2020Chemical Problem; Chemical Problem

  A BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THEY EXPERIENCED LOW CONDUCTIVITY WITH LOT NUMBER 20LXAC051. PER THE BIOMED, DURING TREATMENT THE CONDUCTIVITY WAS AT 12.9 AND THE PATIENTS WERE SWITCHED MID-TREATMENT TO ANOTHER LOT OF NATURALYTE WITHOUT ANY ILL EFFECTS OR ADVERSE EVENTS. THE BIOMED DOES NOT KNOW WHAT LOT THE PATIENTS WERE SWITCHED TO. THE CLINIC USES NATURALYTE BICARBONATE, TYPE AND LOT UNKNOWN. PER THE BIOMED, 4 CASES ARE AFFECTED AND THERE HAS NOT BEEN ANY RECENT SERVICE TO THE MACHINES THAT WOULD AFFECT THE CONDUCTIVITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10913704 ↗
• MalfunctionNov 25, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THE CITRASATE WOULD NOT COME UP TO CONDUCTIVITY. UPON FOLLOW UP, IT WAS REPORTED THAT DURING USE, THE CONDUCTIVITY WAS AT 13.0, AND THAT THE PATIENTS WERE SWITCHED TO A GRANUFLO (LOT NUMBER UNKNOWN). PER THE BIOMED, THERE WERE NO ADVERSE EVENTS OR ILL EFFECTS. THERE WAS 1 CASE AFFECTED. THEY CLINIC USES NATURALYTE BICARBONATE 45X, LOT NUMBER 20HXBC010. THE BIOMED REPORTED THAT THERE HAS BEEN NO SERVICE TO THE MACHINE. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10906236 ↗
• MalfunctionNov 25, 2020Chemical Problem; Chemical Problem

  A HEMODIALYSIS (HD) CLINIC BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THE CITRASATE WOULD NOT COME UP TO CONDUCTIVITY. UPON FOLLOW UP, IT WAS REPORTED THAT DURING USE, THE CONDUCTIVITY WAS AT 13.0, AND THAT THE PATIENTS WERE SWITCHED TO A GRANUFLO (LOT NUMBER UNKNOWN). PER THE BIOMED, THERE WERE NO ADVERSE EVENTS OR ILL EFFECTS. THERE WAS 1 CASE AFFECTED. THEY CLINIC USES NATURALYTE BICARBONATE 45X, LOT NUMBER 20HXBC010. THE BIOMED REPORTED THAT THERE HAS BEEN NO SERVICE TO THE MACHINE. A RETURN GOODS AUTHORIZATION (RGA) WAS ISSUED TO THE CLINIC FOR PRODUCT RETURN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10906147 ↗