Lixelle S-15 (REF N/A)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 14993478020218), received between Dec 25, 2016 and Apr 27, 2023 — classified as 9 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  A PATIENT (63 YEARS OLD, MALE) WHO RECEIVED THE FIRST TREATMENT WITH THIS PRODUCT ON (B)(6) 2023 BECAME IN THE STATE OF "CHEST PAIN, UNCONSCIOUSNESS, AND DECREASED SPO2 (93%)" ABOUT 1 HOUR AFTER THE START. DETAILS OF ACTION TAKEN: TREATMENT WAS URGENTLY STOPPED (FINISHED), AND STEROID ADMINISTRATION WAS IMPLEMENTED. OUTCOME: TWO DAYS LATER, ON (B)(6)2023, THE PATIENT'S SYMPTOMS RESOLVED. FURTHER TREATMENT WITH LIXELLE FOR THIS PATIENT HAS BEEN DISCONTINUED. IN ADDITION, WE TRIED TO OBTAIN ADDITIONAL INFORMATION MULTIPLE TIMES, BUT WE DID NOT RECEIVE A RESPONSE FROM THE FACILITY, SO THE DETAILS OF THE PROBLEM OTHER THAN THE ABOVE ARE UNKNOWN.

  Patient problems: Chest Pain; Low Oxygen Saturation; Presyncope

  MAUDE report 16821796 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS A MALE PATIENT ON CHRONIC HEMODIALYSIS (HD), AND HAD RECEIVED HD WITH LIXELLE, 3 TIMES PER WEEK, SINCE (B)(6) 2016. THE COLUMN SIZE OF THE LIXELLE USED WAS INCREASED FROM S-15 (150ML), S-25 (250ML) AND THEN TO S-35 (350ML). ON (B)(6) 2016 (IN THE PREVIOUS TREATMENT WITH LIXELLE S-35, 2 DAYS BEFORE THE DATE OF THIS INCIDENT) HE ALLEGED SYMPTOMS AT AROUND 20 MIN. BEFORE THE END OF THE TREATMENT. HE WAS TACHYCARDIC, HAD MORE CHILLS WITH FEVER (AROUND 101.5 F). HE REFUSED TO GO TO ER AND GOT CHEST X RAY DONE AT THAT TIME. HE FELT BETTER AFTER GETTING ANTIBIOTICS (VANCO 1G & CEFEPIME 2G SINCE HE WAS ALLERGIC TO GENTAMYCIN.). BECAUSE INFECTION WAS SUSPECTED, A BLOOD CULTURE WAS DONE (THE RESULTS WAS NEGATIVE AS OF (B)(6) 2016). ON (B)(6) 2016, IT WAS HIS 28TH TREATMENTS WITH LIXELLE, WHERE S-35 WAS USED, HE COMPLAINED MILD CHILLS WITH FEVER OF 101.2 F TOWARDS THE END OF THE TREATMENT. VANCO 1G & CEFEPIME 2G IV WERE GIVEN AFTER THE TREATMENT AND HIS SYMPTOMS CEASED. A BLOOD CULTURE WAS DONE AGAIN. HE HAS HAD FLUID OVERLOAD SINCE THE PREVIOUS TREATMENT (700ML POSITIVE BECAUSE HE WAS GIVEN CONSIDERABLE AMOUNT OF NORMAL SALINE POST HD DUE TO HYPOTENSION). HOWEVER, HE HAD REMA

  Patient problems: Chills; Fever; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 11894900 ↗
• InjuryApr 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HISTORY IS HYPERTENSION, HYPERLIPIDEMIA. ORMESARTAN 5 MG AND AMLODIPINE 5 MG WERE TAKEN ORALLY ON THE MORNING OF TREATMENT. DURING DIALYSIS, IT REMAINED AROUND BP120, AND SOMETIMES IT WAS 90-150. WHEN THE STAFF RETURNED TO THE BEDSIDE TO RETURN BLOOD, THE PATIENT LOST CONSCIOUSNESS (SYNCOPE), AND THE PATIENT DID NOT RESPOND TO THE CALL WITH THE EYES OPEN. THE PATIENT'S LOWER LIMBS WERE LIFTED AND BLOOD WAS RETURNED. AFTER 1-2 MINUTES, THE EYES WERE FLUTTERED AND THE CALL WAS RESPONDED. AT THE END OF BLOOD RETURN, 80 BP, NO ABNORMAL OXYGEN VALUE.

  Patient problems: Loss of consciousness; Low Blood Pressure/ Hypotension

  MAUDE report 9999541 ↗
• InjuryNov 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ORIGINALLY HYPERTENSIVE AND OCCASIONALLY DEVELOPED ARRHYTHMIAS. THE BLOOD PRESSURE DURING DIALYSIS TREATMENT WAS IN THE 150 MMHG RANGE, BUT AFTER THE START OF LIXELLE S-15 TREATMENT, IT DROPPED TO THE 70 MMHG RANGE, AND THE PULSE INCREASED FROM 70 TO 120. BECAUSE AN ARRHYTHMIA DEVELOPED, A DEFIBRILLATION PROCEDURE WAS PERFORMED. THERE WAS ALSO GENERAL PAIN DUE TO DECREASED BLOOD PRESSURE. THE PATIENT WAS TREATED WITH LIXELLE ONCE 8 YEARS AGO, AND TACHYCARDIA OCCURRED AND THE TREATMENT WAS STOPPED.

  Patient problems: Arrhythmia; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 9303205 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT NARRATIVE: LIXELLE S-15 IN COMBINATION WITH A DIALYZER WAS USED FOR THE TREATMENT OF DIALYSIS-RELATED AMYLOIDOSIS. LIXELLE TREATMENT WITH DIALYSIS (LIXELLE) STARTED FROM (B)(6) 2017, AND HAD BEEN CONDUCTED WITHOUT PROBLEMS. ON (B)(6) 2018 LIXELLE FOR 4 HOURS WAS PLANNED. THE PATIENT COMPLAINED OF CONSTIPATION AND LOSS OF APPETITE BEFORE LIXELLE. SINCE BLOOD PRESSURE (BP) DROPPED TO 80 MMHG AND SYMPTOMS SUCH AS, COLD SWEATS, NAUSEA, HEADACHE, STOMACHACHE, ETC WERE OBSERVED DURING THE TREATMENT, THE LIXELLE WAS TERMINATED IN 3 HOURS. A TOTAL OF 700 ML OF SALINE WAS ADMINISTERED DURING THE LIXELLE. ON (B)(6), (B)(6), (B)(6), AND (B)(6), HEMODIALYSIS TREATMENTS ONLY WERE CONDUCTED. BP DURING THE HEMODIALYSIS WAS STABLE AT AROUND 150 MMHG. ON (B)(6) LIXELLE WAS RESUMED AND AT THE START BP WAS 159 MM HG. AT 15 MIN AFTER LIXELLE BP DECREASED TO 116 MMHG, AND 100ML OF SALINE WAS ADMINISTERED. AT 30 MIN BP DECREASED TO 81 MMHG. AT 40 MIN THE PATIENT COMPLAINED OF FEELING BAD, AND 100 ML OF SALINE WAS ADMINISTERED. THE BP WAS 90 MMHG. AT 45 MIN BP WAS 78 MMHG, AND 200 ML OF SALINE WAS ADMINISTERED. AT 80 MIN BP WAS 105 MMHG. EVEN AFTER ADMINISTRATION OF SALINE BP SHOWED NO RECOVERY. LI

  Patient problems: Hypovolemic Shock; Low Blood Pressure/ Hypotension

  MAUDE report 8072411 ↗
• InjuryApr 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUBJECT WAS A (B)(6)-YEAR-OLD FEMALE ON CHRONIC HEMODIALYSIS (3 TIMES A WEEK) FOR 40 YEARS. THE LIXELLE S-15, BETA2-MICROGLOBULIN ADSORPTION COLUMN, WAS INTRODUCED FOR THE TREATMENT OF HER DIALYSIS RELATED AMYLOIDOSIS (DRA). THE LIXELLE IS USED TO ADD IN THE HEMODIALYSIS CIRCUIT USUALLY BEFORE A DIALYZER IN EVERY HEMODIALYSIS PROCEDURE. DURING THE 3RD TREATMENT WITH THE LIXELLE ON (B)(6) 2018, SHE DEVELOPED DYSPNEA WITH HYPOTENSION IN 40 MINUTES AFTER INITIATING THE TREATMENT. OXYGEN SUPPLY WAS STARTED (SPO2 WAS 83%) AND THE DEHYDRATION ON THE HEMODIALYSIS WAS STOPPED. ALTHOUGH THE OXYGEN SUPPLY WAS CONTINUED HER RESPIRATORY DISTRESS PERSISTED. IN ABOUT 135 MINUTES AFTER THE INITIATION OF THE TREATMENT, HER BP HAD RISEN TO 140MMHG, SPO2 HAD REACHED 99%, THE HYDRATION PROCEDURE WAS RESUMED. HER RESPIRATORY DISTRESS PERSISTED, HER BODY TEMPERATURE RAISED TO 38.0 DEGREES, AND THE TREATMENT WAS TERMINATED IN 45 MINUTES AFTER RESUMING THE PROCEDURE. AFTER THE TREATMENT, THE PATIENT COULD NOT STAND UP BY HERSELF. BECAUSE OF STRONG FATIGUE AND HIGH INFLAMMATORY RESPONSE, SHE WAS HOSPITALIZED AFTER ER VISIT.

  Patient problems: Chest Pain; Dyspnea; Fatigue; Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Respiratory Distress

  MAUDE report 7410392 ↗
• InjuryApr 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUBJECT IS A HEMODIALYSIS PATIENT WHO STARTED USING LIXELLE S-25, BETA2-MICROGLOBULIN ADSORPTION COLUMN, TOGETHER WITH HEMODIALYSIS BECAUSE OF THE TREATMENT OF DIALYSIS RELATED AMYLOIDOSIS SINCE (B)(6) 2010. BECAUSE OF A TENDENCY OF HYPOTENSION APPEARED IN THE TREATMENTS WITH LIXELLE, THE TYPE OF LIXELLE HAS BEEN SWITCHED TO LIXELLE S-15, WITH LESS PRIMING VOLUME, TO AVOID BLOOD PRESSURE-LOWERING DURING THE TREATMENTS WITH LIXELLE SINCE SEVERAL YEARS BEFORE. ON (B)(6) 2018, A BLOOD LEAK-ALARM WAS GENERATED IMMEDIATELY AFTER STARTING THE TREATMENT. VISIBLE COLORING WAS SEEN IN THE DIALYSATE, ALTHOUGH NO CONSPICUOUS BREAKAGE OF THE HOLLOW FIBER OF THE DIALYZER (ASAHI-KASEI MEDICAL APS-15EA) COULD BE CONFIRMED. COLORED DIALYSATE WAS COLLECTED AND OBSERVED UNDER A MICROSCOPE. THE RESULTS SHOWED NO BLOOD CELLS AND NO BROKEN BLOOD CELLS, BUT OCCULT BLOOD WAS POSITIVE BY USING A URINE TEST STRIP. THE COLORATION WAS JUDGED TO BE FREE HEMOGLOBIN, AND THE BREAKAGE OF THE DIALYSIS MEMBRANE WAS DENIED. THEN, THE TREATMENT WAS RESUMED WITH THE SAME DIALYZER, BUT THE DIALYSATE BECAME COLORED AND A BLOOD LEAK-ALARM CAME OUT AGAIN. SINCE SO-CALLED "GRINDING" OF BLOOD CELLS BY THE ROLLER OF BLO

  Patient problems: Abdominal Pain; Hemolysis

  MAUDE report 7391246 ↗
• InjuryFeb 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS DEVICE, LIXELLE BETA2-MICROGLOBULIN APHERESIS COLUMN (LIXELLE), WAS INTRODUCED TO A (B)(6) YEARS OF AGE FEMALE PATIENT ON CHRONIC HEMODIALYSIS FOR 27 YEARS FOR THE TREATMENT OF HER DIALYSIS RELATED AMYLOIDOSIS (DRA). THE REPORTED EVENT OCCURRED ON THE VERY FIRST TREATMENT WITH LIXELLE. FOR THIS TREATMENT, A HEMODIALYSIS MODULE WAS CHANGED TO FX-CORDIAX 140 (FRESENIUS) FROM RENAK PS 1.6 (KAWASUMI) IN ORDER TO REDUCE THE TOTAL PRIMING VOLUME. THE PATIENT SHOWED MOOD DISCOMFORT 10 MINUTES BEFORE THE END OF THE TREATMENT, WAS RECOGNIZED ARRHYTHMIA, AND THEN LOST CONSCIOUSNESS. THE PATIENT WAS GIVEN I.V. 300ML OF PHYSIOLOGICAL SALINE AND THEN, SHE BECAME RESPONDING TO VOICE CALL IN 8 MINUTES AFTER HER LOST CONSCIOUSNESS, AND HER ARRHYTHMIA CEASED. ADDITIONAL 200ML OF PHYSIOLOGICAL SALINE WAS GIVEN AND HER MOOD DISCOMFORT DISAPPEARED IN 30 MINUTES AFTER HER LOST CONSCIOUSNESS. SINCE THEN, THE PATIENT IS CONTINUED ON HEMODIALYSIS WITHOUT LIXELLE BY USING RENAK PS 1.6.

  Patient problems: Arrhythmia; Discomfort; High Blood Pressure/ Hypertension; Loss of consciousness; Tachycardia

  MAUDE report 7269107 ↗
• InjuryDec 25, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS A MALE PATIENT ON CHRONIC HEMODIALYSIS (HD), AND HAD RECEIVED HD WITH LIXELLE, 3 TIMES PER WEEK, SINCE (B)(6) 2016. THE COLUMN SIZE OF THE LIXELLE USED WAS INCREASED FROM S-15 (150ML), S-25 (250ML) AND THEN TO S-35 (350ML). ON (B)(6) 2016 (IN THE PREVIOUS TREATMENT WITH LIXELLE S-35, 2 DAYS BEFORE THE DATE OF THIS INCIDENT) HE ALLEGED SYMPTOMS AT AROUND 20 MIN. BEFORE THE END OF THE TREATMENT. HE WAS TACHYCARDIC, HAD MORE CHILLS WITH FEVER (AROUND 101.5 F). HE REFUSED TO GO TO ER AND GOT CHEST X RAY DONE AT THAT TIME. HE FELT BETTER AFTER GETTING ANTIBIOTICS (VANCO 1G & CEFEPIME 2G SINCE HE WAS ALLERGIC TO GENTAMYCIN.). BECAUSE INFECTION WAS SUSPECTED, A BLOOD CULTURE WAS DONE (THE RESULTS WAS NEGATIVE AS OF (B)(6) 2016). ON (B)(6) 2016, IT WAS HIS 28TH TREATMENTS WITH LIXELLE, WHERE S-35 WAS USED, HE COMPLAINED MILD CHILLS WITH FEVER OF 101.2 F TOWARDS THE END OF THE TREATMENT. VANCO 1G & CEFEPIME 2G IV WERE GIVEN AFTER THE TREATMENT AND HIS SYMPTOMS CEASED. A BLOOD CULTURE WAS DONE AGAIN. HE HAS HAD FLUID OVERLOAD SINCE THE PREVIOUS TREATMENT (700ML POSITIVE BECAUSE HE WAS GIVEN CONSIDERABLE AMOUNT OF NORMAL SALINE POST HD DUE TO HYPOTENSION). HOWEVER, HE HAD REMA

  Patient problems: Chills; Fever; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 6203743 ↗
• MalfunctionDec 25, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CASE WAS A MALE PATIENT ON HIS 60S OF AGE WITH CHRONIC HEMODIALYSIS (HD) ACCOMPANIED WITH DIALYSIS-RELATED AMYLOIDOSIS (DRA). WHEN AN ON-LINE HEMODIAFILTRATION (HDF) WAS INTRODUCED TO THE PATIENT IN ORDER TO IMPROVE WORSENED SYMPTOMS OF DRA, HE EXPERIENCED A SIGNIFICANT HYPOTENSION AT 30 MIN. AFTER BEGINNING THE TREATMENT. THE BLOOD TEST REVEALED THAT HE WAS POSITIVE IN ALLERGY TO POLYVINYLPYRROLIDONE (PVP). THE HDF WAS SWITCHED TO A HEMODIALYSIS (HD) BY USING A POLYSULFONE HEMODIALYZER, APS (ASAHI KASEI MEDICAL), BUT A SIGNIFICANT HYPOTENSION REOCCURRED IN 12TH OR 13TH HD WITH THE APS, AND THEN, THE HEMODIALYZER WAS CHANGED TO A CELLULOSE TRIACETATE HEMODIALYZER, FB-190UB (NIPRO), AND THE COMPLICATION HAD NOT RECURRED SINCE THEN. SINCE HIS DRA EXACERBATED AGAIN, LIXELLE S-15, BETA2-MICROGLOBULINE ADSORPTION COLUMN, WAS ADDED ON THE HD WITH THE FB-190UB. IN HIS FIRST HD WITH THE LIXELLE, HIS BLOOD PRESSURE (BP) DROPPED FROM 148 MMHG TO 72 MMHG AT ABOUT ONE HOUR AFTER STARTING THE TREATMENT AND HE FELL INTO A STATE OF SHOCK. THE TREATMENT WAS STOPPED IMMEDIATELY AND HE RECOVERED WITH A SALINE INFUSION. HIS BP RETURNED TO 130'S MMHG AT THE TERMINATION OF THE TREATMENT.

  Patient problems: Hypovolemia; Hypovolemic Shock; Low Blood Pressure/ Hypotension

  MAUDE report 6203729 ↗