Optiflux® 0500320NRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00840861100132), received between Jun 18, 2018 and Oct 14, 2020 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2020Fluid/Blood Leak; Fluid/Blood Leak

  A USER FACILITY REPORTED THAT A DIALYZER BLOOD LEAK OCCURRED APPROXIMATELY 10 MINUTES INTO A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A BAXTER GAMBRO ARTIS MACHINE, ALARMED WITH A BLOOD LEAK ALARM. THE LEAK WAS CONFIRMED TO BE INTERNAL AND VISUALLY OBSERVED WITHIN THE FIBERS OF THE DIALYZER BY THE REGISTERED NURSE (RN). THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. ADDITIONAL PATIENT DETAILS WERE REQUESTED BUT COULD NOT BE PROVIDED PER CANADIAN PATIENT PRIVACY GUIDELINES. THE COMPLAINT DEVICE WAS REPORTED TO BE UNAVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10681324 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINIC RESPONSE ON AN UNRELATED CUSTOMER EXPERIENCE INDICATES THAT THE HEMODIALYSIS PATIENT ENCOUNTERED A DIALYZER REACTION, CHILLS, FATIGUE, GASTROINTESTINAL BLEEDING AND THROMBOCYTOPENIA AFTER 27 HEMODIALYSIS TREATMENTS. EXACT DATES UNKNOWN. DOCUMENTATION IN RELATED FILES STATES THE PATIENT BECAME THROMBOCYTOPENIC WITH EACH DIALYSIS TREATMENT AND WOULD BLEED FROM HIS ARTERIAL/VENOUS (AV) MALFORMATIONS (SPECIFICS UNKNOWN). THE COMMUNICATION REVEALED THE PATIENT WAS RECEIVING HD (TREATMENT DETAILS UNKNOWN) THERAPY UTILIZING AN OPTIFLUX 200NR DIALYZER. IT WAS REPORTED A ¿BLUE TOP TUBE¿ (DATE OF COLLECTION AND TEST(S) UNKNOWN) WAS UTILIZED TO CONFIRM THE LOW PLATELET COUNT (VALUE UNKNOWN) WAS NOT CAUSED BY ¿CLUMPING.¿ THE NEPHROLOGIST ATTRIBUTES THE DECREASED PLATELET COUNT TO A DIALYZER (POLYSULFONE) REACTION AS THE PATIENT¿S PLATELET COUNT WAS WITHIN NORMAL LIMITS (NORMAL RANGE = 150,000 TO 450,000 MCL) PRIOR TO BEGINNING HD IN (B)(6) 2017. ADDITIONALLY, IT WAS REPORTED THE PATIENT RECEIVES NO HEPARIN BEFORE OR DURING DIALYSIS. AT THE TIME OF THE EVENT(S) THE PATIENT HAD RECENTLY UNDERWENT A CORONARY ARTERY STENT, AND WAS TAKING PLAVIX (DOSAGE AND FREQUENCY UNKNOWN) AND ASPIRIN (DO

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7616145 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINIC RESPONSE ON AN UNRELATED CUSTOMER EXPERIENCE INDICATES THAT THE HEMODIALYSIS PATIENT ENCOUNTERED A DIALYZER REACTION, CHILLS, FATIGUE, GASTROINTESTINAL BLEEDING AND THROMBOCYTOPENIA AFTER 27 HEMODIALYSIS TREATMENTS. EXACT DATES UNKNOWN. DOCUMENTATION IN RELATED FILES STATES THE PATIENT BECAME THROMBOCYTOPENIC WITH EACH DIALYSIS TREATMENT AND WOULD BLEED FROM HIS ARTERIAL/VENOUS (AV) MALFORMATIONS (SPECIFICS UNKNOWN). THE COMMUNICATION REVEALED THE PATIENT WAS RECEIVING HD (TREATMENT DETAILS UNKNOWN) THERAPY UTILIZING AN OPTIFLUX 200NR DIALYZER. IT WAS REPORTED A ¿BLUE TOP TUBE¿ (DATE OF COLLECTION AND TEST(S) UNKNOWN) WAS UTILIZED TO CONFIRM THE LOW PLATELET COUNT (VALUE UNKNOWN) WAS NOT CAUSED BY ¿CLUMPING.¿ THE NEPHROLOGIST ATTRIBUTES THE DECREASED PLATELET COUNT TO A DIALYZER (POLYSULFONE) REACTION AS THE PATIENT¿S PLATELET COUNT WAS WITHIN NORMAL LIMITS (NORMAL RANGE = 150,000 TO 450,000 MCL) PRIOR TO BEGINNING HD IN (B)(6) 2017. ADDITIONALLY, IT WAS REPORTED THE PATIENT RECEIVES NO HEPARIN BEFORE OR DURING DIALYSIS. AT THE TIME OF THE EVENT(S) THE PATIENT HAD RECENTLY UNDERWENT A CORONARY ARTERY STENT, AND WAS TAKING PLAVIX (DOSAGE AND FREQUENCY UNKNOWN) AND ASPIRIN (DO

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7616116 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINIC RESPONSE ON AN UNRELATED CUSTOMER EXPERIENCE INDICATES THAT THE HEMODIALYSIS PATIENT ENCOUNTERED A DIALYZER REACTION, CHILLS, FATIGUE, GASTROINTESTINAL BLEEDING AND THROMBOCYTOPENIA AFTER 27 HEMODIALYSIS TREATMENTS. EXACT DATES UNKNOWN. DOCUMENTATION IN RELATED FILES STATES THE PATIENT BECAME THROMBOCYTOPENIC WITH EACH DIALYSIS TREATMENT AND WOULD BLEED FROM HIS ARTERIAL/VENOUS (AV) MALFORMATIONS (SPECIFICS UNKNOWN). THE COMMUNICATION REVEALED THE PATIENT WAS RECEIVING HD (TREATMENT DETAILS UNKNOWN) THERAPY UTILIZING AN OPTIFLUX 200NR DIALYZER. IT WAS REPORTED A ¿BLUE TOP TUBE¿ (DATE OF COLLECTION AND TEST(S) UNKNOWN) WAS UTILIZED TO CONFIRM THE LOW PLATELET COUNT (VALUE UNKNOWN) WAS NOT CAUSED BY ¿CLUMPING.¿ THE NEPHROLOGIST ATTRIBUTES THE DECREASED PLATELET COUNT TO A DIALYZER (POLYSULFONE) REACTION AS THE PATIENT¿S PLATELET COUNT WAS WITHIN NORMAL LIMITS (NORMAL RANGE = 150,000 TO 450,000 MCL) PRIOR TO BEGINNING HD IN (B)(6) 2017. ADDITIONALLY, IT WAS REPORTED THE PATIENT RECEIVES NO HEPARIN BEFORE OR DURING DIALYSIS. AT THE TIME OF THE EVENT(S) THE PATIENT HAD RECENTLY UNDERWENT A CORONARY ARTERY STENT, AND WAS TAKING PLAVIX (DOSAGE AND FREQUENCY UNKNOWN) AND ASPIRIN (DO

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7616055 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINIC RESPONSE ON AN UNRELATED CUSTOMER EXPERIENCE INDICATES THAT THE HEMODIALYSIS PATIENT ENCOUNTERED A DIALYZER REACTION, CHILLS, FATIGUE, GASTROINTESTINAL BLEEDING AND THROMBOCYTOPENIA AFTER 27 HEMODIALYSIS TREATMENTS. EXACT DATES UNKNOWN. DOCUMENTATION IN RELATED FILES STATES THE PATIENT BECAME THROMBOCYTOPENIC WITH EACH DIALYSIS TREATMENT AND WOULD BLEED FROM HIS ARTERIAL/VENOUS (AV) MALFORMATIONS (SPECIFICS UNKNOWN). THE COMMUNICATION REVEALED THE PATIENT WAS RECEIVING HD (TREATMENT DETAILS UNKNOWN) THERAPY UTILIZING AN OPTIFLUX 200NR DIALYZER. IT WAS REPORTED A ¿BLUE TOP TUBE¿ (DATE OF COLLECTION AND TEST(S) UNKNOWN) WAS UTILIZED TO CONFIRM THE LOW PLATELET COUNT (VALUE UNKNOWN) WAS NOT CAUSED BY ¿CLUMPING.¿ THE NEPHROLOGIST ATTRIBUTES THE DECREASED PLATELET COUNT TO A DIALYZER (POLYSULFONE) REACTION AS THE PATIENT¿S PLATELET COUNT WAS WITHIN NORMAL LIMITS (NORMAL RANGE = 150,000 TO 450,000 MCL) PRIOR TO BEGINNING HD IN (B)(6) 2017. ADDITIONALLY, IT WAS REPORTED THE PATIENT RECEIVES NO HEPARIN BEFORE OR DURING DIALYSIS. AT THE TIME OF THE EVENT(S) THE PATIENT HAD RECENTLY UNDERWENT A CORONARY ARTERY STENT, AND WAS TAKING PLAVIX (DOSAGE AND FREQUENCY UNKNOWN) AND ASPIRIN (DO

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7616011 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINIC RESPONSE ON AN UNRELATED CUSTOMER EXPERIENCE INDICATES THAT THE HEMODIALYSIS PATIENT ENCOUNTERED A DIALYZER REACTION, CHILLS, FATIGUE, GASTROINTESTINAL BLEEDING AND THROMBOCYTOPENIA AFTER 27 HEMODIALYSIS TREATMENTS. EXACT DATES UNKNOWN. DOCUMENTATION IN RELATED FILES STATES THE PATIENT BECAME THROMBOCYTOPENIC WITH EACH DIALYSIS TREATMENT AND WOULD BLEED FROM HIS ARTERIAL/VENOUS (AV) MALFORMATIONS (SPECIFICS UNKNOWN). THE COMMUNICATION REVEALED THE PATIENT WAS RECEIVING HD (TREATMENT DETAILS UNKNOWN) THERAPY UTILIZING AN OPTIFLUX 200NR DIALYZER. IT WAS REPORTED A ¿BLUE TOP TUBE¿ (DATE OF COLLECTION AND TEST(S) UNKNOWN) WAS UTILIZED TO CONFIRM THE LOW PLATELET COUNT (VALUE UNKNOWN) WAS NOT CAUSED BY ¿CLUMPING.¿ THE NEPHROLOGIST ATTRIBUTES THE DECREASED PLATELET COUNT TO A DIALYZER (POLYSULFONE) REACTION AS THE PATIENT¿S PLATELET COUNT WAS WITHIN NORMAL LIMITS (NORMAL RANGE = 150,000 TO 450,000 MCL) PRIOR TO BEGINNING HD IN (B)(6) 2017. ADDITIONALLY, IT WAS REPORTED THE PATIENT RECEIVES NO HEPARIN BEFORE OR DURING DIALYSIS. AT THE TIME OF THE EVENT(S) THE PATIENT HAD RECENTLY UNDERWENT A CORONARY ARTERY STENT, AND WAS TAKING PLAVIX (DOSAGE AND FREQUENCY UNKNOWN) AND ASPIRIN (DO

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7615980 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINIC RESPONSE ON AN UNRELATED CUSTOMER EXPERIENCE INDICATES THAT THE HEMODIALYSIS PATIENT ENCOUNTERED A DIALYZER REACTION, CHILLS, FATIGUE, GASTROINTESTINAL BLEEDING AND THROMBOCYTOPENIA AFTER 27 HEMODIALYSIS TREATMENTS. EXACT DATES UNKNOWN. DOCUMENTATION IN RELATED FILES STATES THE PATIENT BECAME THROMBOCYTOPENIC WITH EACH DIALYSIS TREATMENT AND WOULD BLEED FROM HIS ARTERIAL/VENOUS (AV) MALFORMATIONS (SPECIFICS UNKNOWN). THE COMMUNICATION REVEALED THE PATIENT WAS RECEIVING HD (TREATMENT DETAILS UNKNOWN) THERAPY UTILIZING AN OPTIFLUX 200NR DIALYZER. IT WAS REPORTED A ¿BLUE TOP TUBE¿ (DATE OF COLLECTION AND TEST(S) UNKNOWN) WAS UTILIZED TO CONFIRM THE LOW PLATELET COUNT (VALUE UNKNOWN) WAS NOT CAUSED BY ¿CLUMPING.¿ THE NEPHROLOGIST ATTRIBUTES THE DECREASED PLATELET COUNT TO A DIALYZER (POLYSULFONE) REACTION AS THE PATIENT¿S PLATELET COUNT WAS WITHIN NORMAL LIMITS (NORMAL RANGE = 150,000 TO 450,000 MCL) PRIOR TO BEGINNING HD IN (B)(6) 2017. ADDITIONALLY, IT WAS REPORTED THE PATIENT RECEIVES NO HEPARIN BEFORE OR DURING DIALYSIS. AT THE TIME OF THE EVENT(S) THE PATIENT HAD RECENTLY UNDERWENT A CORONARY ARTERY STENT, AND WAS TAKING PLAVIX (DOSAGE AND FREQUENCY UNKNOWN) AND ASPIRIN (DO

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7615974 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINIC RESPONSE ON AN UNRELATED CUSTOMER EXPERIENCE INDICATES THAT THE HEMODIALYSIS PATIENT ENCOUNTERED A DIALYZER REACTION, CHILLS, FATIGUE, GASTROINTESTINAL BLEEDING AND THROMBOCYTOPENIA AFTER 27 HEMODIALYSIS TREATMENTS. EXACT DATES UNKNOWN. DOCUMENTATION IN RELATED FILES STATES THE PATIENT BECAME THROMBOCYTOPENIC WITH EACH DIALYSIS TREATMENT AND WOULD BLEED FROM HIS ARTERIAL/VENOUS (AV) MALFORMATIONS (SPECIFICS UNKNOWN). THE COMMUNICATION REVEALED THE PATIENT WAS RECEIVING HD (TREATMENT DETAILS UNKNOWN) THERAPY UTILIZING AN OPTIFLUX 200NR DIALYZER. IT WAS REPORTED A ¿BLUE TOP TUBE¿ (DATE OF COLLECTION AND TEST(S) UNKNOWN) WAS UTILIZED TO CONFIRM THE LOW PLATELET COUNT (VALUE UNKNOWN) WAS NOT CAUSED BY ¿CLUMPING.¿ THE NEPHROLOGIST ATTRIBUTES THE DECREASED PLATELET COUNT TO A DIALYZER (POLYSULFONE) REACTION AS THE PATIENT¿S PLATELET COUNT WAS WITHIN NORMAL LIMITS (NORMAL RANGE = 150,000 TO 450,000 MCL) PRIOR TO BEGINNING HD IN (B)(6) 2017. ADDITIONALLY, IT WAS REPORTED THE PATIENT RECEIVES NO HEPARIN BEFORE OR DURING DIALYSIS. AT THE TIME OF THE EVENT(S) THE PATIENT HAD RECENTLY UNDERWENT A CORONARY ARTERY STENT, AND WAS TAKING PLAVIX (DOSAGE AND FREQUENCY UNKNOWN) AND ASPIRIN (DO

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7615707 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "."

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7615621 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "."

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7615616 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "."

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7615579 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "."

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7615559 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINIC RESPONSE ON AN UNRELATED CUSTOMER EXPERIENCE INDICATES THAT THE HEMODIALYSIS PATIENT ENCOUNTERED A DIALYZER REACTION, CHILLS, FATIGUE, GASTROINTESTINAL BLEEDING AND THROMBOCYTOPENIA AFTER 27 HEMODIALYSIS TREATMENTS. EXACT DATES UNKNOWN. DOCUMENTATION IN RELATED FILES STATES THE PATIENT BECAME THROMBOCYTOPENIC WITH EACH DIALYSIS TREATMENT AND WOULD BLEED FROM HIS ARTERIAL/VENOUS (AV) MALFORMATIONS (SPECIFICS UNKNOWN). THE COMMUNICATION REVEALED THE PATIENT WAS RECEIVING HD (TREATMENT DETAILS UNKNOWN) THERAPY UTILIZING AN OPTIFLUX 200NR DIALYZER. IT WAS REPORTED A ¿BLUE TOP TUBE¿ (DATE OF COLLECTION AND TEST(S) UNKNOWN) WAS UTILIZED TO CONFIRM THE LOW PLATELET COUNT (VALUE UNKNOWN) WAS NOT CAUSED BY ¿CLUMPING.¿ THE NEPHROLOGIST ATTRIBUTES THE DECREASED PLATELET COUNT TO A DIALYZER (POLYSULFONE) REACTION AS THE PATIENT¿S PLATELET COUNT WAS WITHIN NORMAL LIMITS (NORMAL RANGE = 150,000 TO 450,000 MCL) PRIOR TO BEGINNING HD IN (B)(6) 2017. ADDITIONALLY, IT WAS REPORTED THE PATIENT RECEIVES NO HEPARIN BEFORE OR DURING DIALYSIS. AT THE TIME OF THE EVENT(S) THE PATIENT HAD RECENTLY UNDERWENT A CORONARY ARTERY STENT, AND WAS TAKING PLAVIX (DOSAGE AND FREQUENCY UNKNOWN) AND ASPIRIN (DO

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7615470 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINIC RESPONSE ON AN UNRELATED CUSTOMER EXPERIENCE INDICATES THAT THE HEMODIALYSIS PATIENT ENCOUNTERED A DIALYZER REACTION, CHILLS, FATIGUE, GASTROINTESTINAL BLEEDING AND THROMBOCYTOPENIA AFTER 27 HEMODIALYSIS TREATMENTS. EXACT DATES UNKNOWN. DOCUMENTATION IN RELATED FILES STATES THE PATIENT BECAME THROMBOCYTOPENIC WITH EACH DIALYSIS TREATMENT AND WOULD BLEED FROM HIS ARTERIAL/VENOUS (AV) MALFORMATIONS (SPECIFICS UNKNOWN). THE COMMUNICATION REVEALED THE PATIENT WAS RECEIVING HD (TREATMENT DETAILS UNKNOWN) THERAPY UTILIZING AN OPTIFLUX 200NR DIALYZER. IT WAS REPORTED A ¿BLUE TOP TUBE¿ (DATE OF COLLECTION AND TEST(S) UNKNOWN) WAS UTILIZED TO CONFIRM THE LOW PLATELET COUNT (VALUE UNKNOWN) WAS NOT CAUSED BY ¿CLUMPING.¿ THE NEPHROLOGIST ATTRIBUTES THE DECREASED PLATELET COUNT TO A DIALYZER (POLYSULFONE) REACTION AS THE PATIENT¿S PLATELET COUNT WAS WITHIN NORMAL LIMITS (NORMAL RANGE = 150,000 TO 450,000 MCL) PRIOR TO BEGINNING HD IN (B)(6) 2017. ADDITIONALLY, IT WAS REPORTED THE PATIENT RECEIVES NO HEPARIN BEFORE OR DURING DIALYSIS. AT THE TIME OF THE EVENT(S) THE PATIENT HAD RECENTLY UNDERWENT A CORONARY ARTERY STENT, AND WAS TAKING PLAVIX (DOSAGE AND FREQUENCY UNKNOWN) AND ASPIRIN (DO

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7611098 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "."

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7611064 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINIC RESPONSE ON AN UNRELATED CUSTOMER EXPERIENCE INDICATES THAT THE HEMODIALYSIS PATIENT ENCOUNTERED A DIALYZER REACTION, CHILLS, FATIGUE, GASTROINTESTINAL BLEEDING AND THROMBOCYTOPENIA AFTER 27 HEMODIALYSIS TREATMENTS. EXACT DATES UNKNOWN. DOCUMENTATION IN RELATED FILES STATES THE PATIENT BECAME THROMBOCYTOPENIC WITH EACH DIALYSIS TREATMENT AND WOULD BLEED FROM HIS ARTERIAL/VENOUS (AV) MALFORMATIONS (SPECIFICS UNKNOWN). THE COMMUNICATION REVEALED THE PATIENT WAS RECEIVING HD (TREATMENT DETAILS UNKNOWN) THERAPY UTILIZING AN OPTIFLUX 200NR DIALYZER. IT WAS REPORTED A ¿BLUE TOP TUBE¿ (DATE OF COLLECTION AND TEST(S) UNKNOWN) WAS UTILIZED TO CONFIRM THE LOW PLATELET COUNT (VALUE UNKNOWN) WAS NOT CAUSED BY ¿CLUMPING.¿ THE NEPHROLOGIST ATTRIBUTES THE DECREASED PLATELET COUNT TO A DIALYZER (POLYSULFONE) REACTION AS THE PATIENT¿S PLATELET COUNT WAS WITHIN NORMAL LIMITS (NORMAL RANGE = 150,000 TO 450,000 MCL) PRIOR TO BEGINNING HD IN (B)(6) 2017. ADDITIONALLY, IT WAS REPORTED THE PATIENT RECEIVES NO HEPARIN BEFORE OR DURING DIALYSIS. AT THE TIME OF THE EVENT(S) THE PATIENT HAD RECENTLY UNDERWENT A CORONARY ARTERY STENT, AND WAS TAKING PLAVIX (DOSAGE AND FREQUENCY UNKNOWN) AND ASPIRIN (DO

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7611009 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "."

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7610948 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "."

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7610897 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "."

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7610828 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "."

  Patient problems: Blood Loss; Chills; Fever; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7610812 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINIC RESPONSE ON AN UNRELATED CUSTOMER EXPERIENCE INDICATES THAT THE HEMODIALYSIS PATIENT ENCOUNTERED A DIALYZER REACTION, CHILLS, FATIGUE, GASTROINTESTINAL BLEEDING AND THROMBOCYTOPENIA AFTER 27 HEMODIALYSIS TREATMENTS. EXACT DATES UNKNOWN. DOCUMENTATION IN RELATED FILES STATES THE PATIENT BECAME THROMBOCYTOPENIC WITH EACH DIALYSIS TREATMENT AND WOULD BLEED FROM HIS ARTERIAL/VENOUS (AV) MALFORMATIONS (SPECIFICS UNKNOWN). THE COMMUNICATION REVEALED THE PATIENT WAS RECEIVING HD (TREATMENT DETAILS UNKNOWN) THERAPY UTILIZING AN OPTIFLUX 200NR DIALYZER. IT WAS REPORTED A ¿BLUE TOP TUBE¿ (DATE OF COLLECTION AND TEST(S) UNKNOWN) WAS UTILIZED TO CONFIRM THE LOW PLATELET COUNT (VALUE UNKNOWN) WAS NOT CAUSED BY ¿CLUMPING.¿ THE NEPHROLOGIST ATTRIBUTES THE DECREASED PLATELET COUNT TO A DIALYZER (POLYSULFONE) REACTION AS THE PATIENT¿S PLATELET COUNT WAS WITHIN NORMAL LIMITS (NORMAL RANGE = 150,000 TO 450,000 MCL) PRIOR TO BEGINNING HD IN (B)(6) 2017. ADDITIONALLY, IT WAS REPORTED THE PATIENT RECEIVES NO HEPARIN BEFORE OR DURING DIALYSIS. AT THE TIME OF THE EVENT(S) THE PATIENT HAD RECENTLY UNDERWENT A CORONARY ARTERY STENT, AND WAS TAKING PLAVIX (DOSAGE AND FREQUENCY UNKNOWN) AND ASPIRIN (DO

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7610772 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINIC RESPONSE ON AN UNRELATED CUSTOMER EXPERIENCE INDICATES THAT THE HEMODIALYSIS PATIENT ENCOUNTERED A DIALYZER REACTION, CHILLS, FATIGUE, GASTROINTESTINAL BLEEDING AND THROMBOCYTOPENIA AFTER 27 HEMODIALYSIS TREATMENTS. EXACT DATES UNKNOWN. DOCUMENTATION IN RELATED FILES STATES THE PATIENT BECAME THROMBOCYTOPENIC WITH EACH DIALYSIS TREATMENT AND WOULD BLEED FROM HIS ARTERIAL/VENOUS (AV) MALFORMATIONS (SPECIFICS UNKNOWN). THE COMMUNICATION REVEALED THE PATIENT WAS RECEIVING HD (TREATMENT DETAILS UNKNOWN) THERAPY UTILIZING AN OPTIFLUX 200NR DIALYZER. IT WAS REPORTED A ¿BLUE TOP TUBE¿ (DATE OF COLLECTION AND TEST(S) UNKNOWN) WAS UTILIZED TO CONFIRM THE LOW PLATELET COUNT (VALUE UNKNOWN) WAS NOT CAUSED BY ¿CLUMPING.¿ THE NEPHROLOGIST ATTRIBUTES THE DECREASED PLATELET COUNT TO A DIALYZER (POLYSULFONE) REACTION AS THE PATIENT¿S PLATELET COUNT WAS WITHIN NORMAL LIMITS (NORMAL RANGE = 150,000 TO 450,000 MCL) PRIOR TO BEGINNING HD IN AUGUST, 2017. ADDITIONALLY, IT WAS REPORTED THE PATIENT RECEIVES NO HEPARIN BEFORE OR DURING DIALYSIS. AT THE TIME OF THE EVENT(S) THE PATIENT HAD RECENTLY UNDERWENT A CORONARY ARTERY STENT, AND WAS TAKING PLAVIX (DOSAGE AND FREQUENCY UNKNOWN) AND ASPIRIN (D

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7610691 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "."

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7610669 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "."

  Patient problems: Blood Loss; Chills; Fatigue; Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7610631 ↗