LIPOSORBER LA-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 14993478010110), received between Dec 16, 2016 and Mar 5, 2026 — classified as 4 deaths, 35 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Insufficient Device Problem Information

  THE REPORT CONCERNS A PEDIATRIC PATIENT (MALE, 3.7 YEARS OLD) WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) RECEIVING LDL ADSORPTION THERAPY USING LIPOSORBER LA-15-AU. THE PATIENT UNDERWENT THE 9TH LDL APHERESIS ON (B)(6) 2025. SEPSIS OCCURRED ON (B)(6) 2025 DUE TO MRSA BACTEREMIA WHILE HOSPITALIZED FOR ANOTHER ADVERSE EVENT REPORTED ON 2435151-2026-00002. PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2025, DUE TO ACUTE KIDNEY INJURY (AKI) WITH AN ELEVATED SERUM CREATININE LEVEL OF 1.38 MG/DL. LASIX STARTED DURING ADMISSION. THE PATIENT RECEIVED TWO ROUNDS OF HEMODIALYSIS, LAST BEING ON (B)(6) 2025. THE AKI IMPROVED AS MRSA BACTEREMIA WAS TREATED WITH VANCOMYCIN, AND THE PATIENT DISCHARGED ON (B)(6) 2025. THE PHYSICIAN DETERMINED THE RELATION TO TREATMENT OF THE AKI WAS NO, BECAUSE IT IS RELATED TO THE MRSA BACTEREMIA AND THE PATIENTS PREEXISTING DISEASE PROCESSES.

  Patient problems: Bacteremia; Drug Resistant Bacterial Infection; Kidney injury; Sepsis

  MAUDE report 24518459 ↗
• InjuryJan 22, 2026Insufficient Device Problem Information

  IN THIS CASE, A 3.7-YEAR-OLD MALE FSGS-PAS SUBJECT (B)(6) EXPERIENCED WORSENING EDEMA ON THE DAY AFTER THE LAST TREATMENT WITH LIPOSORBER LA-15-AU (LAST TREATMENT: ON (B)(6) 2025; EVENT DETECTED: ON (B)(6) 2025, 09:55). THE EVENT WAS ASSESSED AS MODERATE AND REQUIRED HOSPITALIZATION WITH ALBUMIN ADMINISTRATION, LASIX, AND ONE HEMODIALYSIS SESSION. NO DEVICE MALFUNCTION WAS REPORTED, AND THE DEVICE WAS DISPOSED OF BY THE HOSPITAL AND NOT RETURNED. THE SITE PRINCIPAL INVESTIGATOR ASSESSED THE EVENT AS NOT SADE (NOT DEVICE-RELATED); THE RATIONALE IS CURRENTLY UNDER INQUIRY. THE MANUFACTURER CONDUCTED A DHR REVIEW (DECEMBER 25, 2025) AND FOUND NO NONCONFORMITIES OR ABNORMALITIES. THIS REPORT IS SUBMITTED AS A PRECAUTION UNDER 21 CFR 803 AND DOES NOT CONSTITUTE AN ADMISSION OF CAUSALITY. MFR#: 3002808904-2025-00038.

  Patient problems: Swelling/ Edema

  MAUDE report 24144113 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  THE REPORT CONCERNS A PEDIATRIC PATIENT (MALE, 3.7 YEARS OLD) WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) RECEIVING LDL ADSORPTION THERAPY USING LIPOSORBER LA-15-AU. THE PATIENT UNDERWENT THE 8TH LIPOSORBER TREATMENT ON (B)(6) 2025. DURING THE TREATMENT, THE PATIENT DEVELOPED INCREASED WORK OF BREATHING (DYSPNEA) AND WAS IMMEDIATELY ADMITTED TO THE HOSPITAL. AT THE TIME OF REPORTING, THE PATIENT REMAINED HOSPITALIZED AND THE FINAL OUTCOME WAS NOT YET AVAILABLE; THE SITE PLANNED TO PROVIDE AN UPDATE WHEN THE OUTCOME BECOMES KNOWN. THE EVENT WAS ASSESSED AS A SERIOUS ADVERSE EVENT (SAE) REQUIRING HOSPITALIZATION; IT WAS NOT CLASSIFIED AS A SERIOUS ADVERSE DEVICE EFFECT (SADE). THE RELATIONSHIP TO THE DEVICE WAS RECORDED AS NOT RELATED. MFR REPORT #: 3002808904-2025-00036.

  Patient problems: Dyspnea

  MAUDE report 23988942 ↗
• InjuryDec 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORT CONCERNS A PEDIATRIC PATIENT (MALE, 3.7 YEARS OLD) WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) RECEIVING LDL ADSORPTION THERAPY USING LIPOSORBER LA-15-AU. THE PATIENT UNDERWENT THE 7TH LIPOSORBER TREATMENT ON (B)(6) 2025. APPROXIMATELY 3-4 DAYS AFTER THE TREATMENT, THE PATIENT DEVELOPED A ~5-POUND WEIGHT GAIN WITH WORSENING EDEMA AND DYSPNEA. ON (B)(6) 2025, THE PATIENT WAS HOSPITALIZED DUE TO WORSENING EDEMA AND SHORTNESS OF BREATH. MEDICAL INTERVENTIONS INCLUDED ALBUMIN INFUSION, IV FUROSEMIDE (LASIX), AND PARACENTESIS. THE PATIENT IMPROVED WITH TREATMENT AND WAS DISCHARGED ON (B)(6) 2025. THE EVENT WAS ASSESSED AS A SERIOUS ADVERSE EVENT (SAE) REQUIRING HOSPITALIZATION; IT WAS NOT CLASSIFIED AS A SERIOUS ADVERSE DEVICE EFFECT (SADE). THE RELATIONSHIP TO THE DEVICE WAS RECORDED AS UNKNOWN, AND THE TREATING PHYSICIAN NOTED THAT THE SAE WAS CONSIDERED RELATED TO THE PATIENT'S UNDERLYING CONDITION RATHER THAN THE DEVICE. MFR REPORT #: 3002808904-2025-00037.

  Patient problems: Abdominal Distention; Ascites; Dyspnea; Kidney injury; Swelling/ Edema

  MAUDE report 23901541 ↗
• InjuryDec 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORT CONCERNS A PEDIATRIC PATIENT (MALE, 3.7 YEARS OLD) WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS) RECEIVING LDL ADSORPTION THERAPY USING LIPOSORBER LA-15-AU. THE PATIENT UNDERWENT THE 7TH LIPOSORBER TREATMENT ON (B)(6) 2025. APPROXIMATELY 3-4 DAYS AFTER THE TREATMENT, THE PATIENT DEVELOPED A ~5-POUND WEIGHT GAIN WITH WORSENING EDEMA AND DYSPNEA. ON (B)(6) 2025, THE PATIENT WAS HOSPITALIZED DUE TO WORSENING EDEMA AND SHORTNESS OF BREATH. MEDICAL INTERVENTIONS INCLUDED ALBUMIN INFUSION, IV FUROSEMIDE (LASIX), AND PARACENTESIS. THE PATIENT IMPROVED WITH TREATMENT AND WAS DISCHARGED ON (B)(6) 2025. THE EVENT WAS ASSESSED AS A SERIOUS ADVERSE EVENT (SAE) REQUIRING HOSPITALIZATION; IT WAS NOT CLASSIFIED AS A SERIOUS ADVERSE DEVICE EFFECT (SADE). THE RELATIONSHIP TO THE DEVICE WAS RECORDED AS UNKNOWN, AND THE TREATING PHYSICIAN NOTED THAT THE SAE WAS CONSIDERED RELATED TO THE PATIENT'S UNDERLYING CONDITION RATHER THAN THE DEVICE.

  Patient problems: Abdominal Distention; Ascites; Dyspnea; Swelling/ Edema

  MAUDE report 23894254 ↗
• InjuryNov 6, 2025Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD NOT RECEIVED TREATMENT FOR APPROXIMATELY 1.5 YEARS, AND THE CURRENT SESSION MARKED THE RESUMPTION OF THERAPY AFTER A PROLONGED INTERRUPTION. APPROXIMATELY 15 MINUTES INTO THE TREATMENT, THE PATIENT DEVELOPED NAUSEA, VOMITING, HYPOTENSION, AND TACHYCARDIA. THE PROCEDURE WAS HALTED, AND THE BLOOD WAS RETURNED TO THE PATIENT. AFTER SYMPTOMATIC IMPROVEMENT, A SECOND TREATMENT WAS INITIATED. HOWEVER, IMMEDIATELY FOLLOWING RE-INITIATION, THE PATIENT EXPERIENCED CHEST PAIN, COLD SWEATS, AND PERIORAL NUMBNESS, PROMPTING EMERGENCY TRANSPORTATION TO A MEDICAL FACILITY. SUBSEQUENT EVALUATION REVEALED THAT THE PATIENT HAD BEEN TAKING AN ACE INHIBITOR, WHICH MAY HAVE CONTRIBUTED TO THE ADVERSE REACTION. THE ATTENDING PHYSICIAN INSTRUCTED TEMPORARY DISCONTINUATION OF THE ACE INHIBITOR AND SCHEDULED RE-TREATMENT 72 HOURS LATER, CONTINGENT UPON STABILIZATION. THE PATIENT RECOVERED, AND THE HEALTHCARE PROVIDER LATER REPORTED TO THE DISTRIBUTOR THAT THE PATIENT WAS IN "GOOD CONDITION."

  Patient problems: Low Blood Pressure/ Hypotension; Presyncope

  MAUDE report 23493592 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WENT FOR FSGS TREATMENT WITH LIPOSORBER ON (B)(6) 2025. NURSE MANAGER REPORTED THAT THE PATIENT HAD NOT HAD TX IN 1.5 YEARS PRIOR TO THIS TX. AFTER 15 MINUTES OF START OF TX NURSE STATED THAT THE PT DEVELOPED NAUSEA/VOMITING, HYPOTENSION, AND TACHYCARDIA. NURSE STATED THE TX WAS STOPPED AND BLOOD WAS RETURNED. AFTER 10 -15 MINUTES AFTER TREATMENT WAS PAUSED, SYMPTOMS IMPROVED AND PER NURSE THE PATIENT WAS PUT BACK ON TREATMENT WITHOUT CONTACTING LIPOSORBER NURSE HOTLINE FOR ADVICE. NURSE REPORTED THAT IMMEDIATELY AFTER RE-STARTING TREATMENT THE PATIENT DEVELOPED CHEST PAIN, HYPOTENSION, DIAPHORETIC, AND NUMBNESS AROUND THE MOUTH. NURSE REPORTED THE TX WAS DISCONTINUED AND PT WAS SENT TO EMERGENCY DEPARTMENT. PHYSICIAN THEN REPORTED SHE FOUND THE PATIENT WAS STILL ON ACE INHIBITOR (LISINOPRIL) DURING THIS TREATMENT AND STATED THAT THE PATIENT WILL BE TAKEN OFF THE ACEI AND THEY WOULD WAIT 72 HOURS PRIOR TO RUNNING TREATMENT AGAIN. PHYSICIAN ALSO REPORTED THE PT WAS DOING WELL.

  Patient problems: Chest Pain; Diaphoresis; Low Blood Pressure/ Hypotension; Nausea; Numbness; Tachycardia; Vomiting

  MAUDE report 23477136 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS ADMITTED ON (B)(6) 2025, WITH WORSENING HEADACHES AND SUSPECTED INCREASED INTRACRANIAL PRESSURE. IMAGING REVEALED STENOSIS OF THE DISTAL RIGHT TRANSVERSE SINUS STENT. BALLOON ANGIOPLASTY WAS PERFORMED ON (B)(6) 2025. THE DEVICE (LIPOSORBER LA-15 SYSTEM) WAS DISCARDED AT THE FACILITY AND NOT RETURNED, MAKING EVALUATION IMPOSSIBLE. ACCORDING TO THE ATTENDING PHYSICIAN, THE CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT IS CURRENTLY UNKNOWN. THIS ADVERSE EVENT OCCURRED APPROXIMATELY 22 MONTHS AFTER THE PATIENT'S LAST LDL APHERESIS TREATMENT USING THE LIPOSORBER LA-15 SYSTEM.

  Patient problems: Headache; Idiopathic Intracranial Hypertension; Restenosis

  MAUDE report 22379700 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  [DIAGNOSIS]: INTRACRANIAL HYPERTENSION. [DESCRIPTION]: PATIENT WAS ADMITTED ON (B)(6) 2025 FOR WORSENING HEADACHES AND CONCERN FOR INCREASED INTRACRANIAL PRESSURE. PATIENT FOUND TO HAVE STENOSIS OF THE DISTAL RIGHT TRANSVERSE SINUS STENT. PT. HOSPITALIZED AND BALLOON ANGIOPLASTY OF RIGHT TRANSVERSE SINUS DISTAL STENT STENOSIS PERFORMED ON (B)(6) 2025. PATIENT WAS RELEASED FROM HOSPITAL ON (B)(6) 2025.

  Patient problems: Headache; Intracranial Pressure Increased; Stenosis

  MAUDE report 22370292 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYMPTOMS: ON (B)(6) 2025. SERUM CREATININE LEVEL INCREASED SHARPLY FROM 1.8 TO 3.5, LEADING TO HOSPITALIZATION FOR ACUTE KIDNEY INJURY (AKI). A RENAL BIOPSY PERFORMED ON (B)(6) CONFIRMED THE FOLLOWING DIAGNOSES: CHRONIC ACTIVE T-CELL MEDIATED REJECTION ACTIVE ANTIBODY-MEDIATED REJECTION THE PATIENT WAS DISCHARGED ON (B)(6). DEVICE ISSUES DURING TREATMENT: NO ISSUES REPORTED. THE DEVICE WAS DISPOSED OF AFTER TREATMENT AND WAS NOT RETURNED. NO DIRECT MALFUNCTION OR ABNORMALITY OF THE PRODUCT WAS REPORTED. "BASED ON THE PHYSICIAN'S CLINICAL ASSESSMENT, IT WAS DETERMINED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED SERIOUS INJURY."

  Patient problems: Autoimmune Disorder; Renal Failure; Renal Impairment

  MAUDE report 22260600 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT ADMITTED FOR ACUTE KIDNEY INJURY (AKI) ON (B)(6) 2025 AFTER CREATININE INCREASED FROM 1.8 TO 3.5. A RENAL BIOPSY ON (B)(6) 2025 SHOWED CHRONIC ACTIVE T CELL MEDIATED REJECTION AND ACTIVE ANTIBODY MEDIATED REJECTION AND DISCHARGED ON (B)(6) 2025. PT IS 24+M AFTER APH.

  Patient problems: Kidney injury

  MAUDE report 22196334 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NURSE EMAILED REPORTING PATIENT'S TREATMENT HAD TO BE D/C D/T PT REPORTING ABD PAIN (6/10 ON PAIN SCALE). PT STATED SHE HAD HER LAST DAY OF MENSES THE DAY BEFORE TREATMENT. JUST BEFORE THE EVENT OCCURRED, THE PATIENT'S VITALS WERE: BP 111/58, HR 95, SPO2 99% ON ROOM AIR. WITH 50 MINUTES REMAINING OF TREATMENT, THE PATIENT BEGAN WRITHING IN SEVERE ABDOMINAL PAIN THAT CAUSED THE PATIENT TO PASS OUT. TREATED PLASMA VOLUME AT THE EVENT: 2400 ML. NURSE TERMINATED TREATMENT AND PATIENT WAS TRANSFERRED TO EMERGENCY ROOM. PER NURSE, THE PATIENT EXPERIENCED RELIEF AFTER 1 HOUR OFF THE TREATMENT AND WAS DISCHARGED HOME. THE PATIENT DID NOT RECEIVE ANY PAIN MEDICATION AND CT SCANS OF THE ABDOMEN WERE NEGATIVE. NURSE STATED THIS PATIENT HAS BEEN RECEIVING TREATMENT FOR OVER A YEAR AND HAS SUCCESSFULLY COMPLETED TREATMENTS WITHOUT ANY COMPLICATIONS. THE TREATING PHYSICIANS HAVE DECIDED TO HOLD OFF TREATMENT UNTIL IT CAN BE DETERMINED WHAT THE ROOT CAUSE OF THE ABDOMINAL PAIN IS. THE TREATING NURSE STATED, SHE DOES NOT BELIEVE IT IS THE LIPOSORBER AND THE PHYSICIANS ARE CONTINUING TO RUN TEST FOR PATIENT TO DETERMINE CAUSE OF ABDOMINAL PAIN. THE KANEKA DEVICE HAS NOT BEEN DETERMINED TO HAVE CAUS

  Patient problems: Abdominal Pain; Loss of consciousness

  MAUDE report 21699282 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (MFR#3002808904-2025-00006) THE INFORMATION FOR THIS CASE WAS COLLECTED IN THE POST-APPROVAL STUDY (TREATMENT OF DRUG-RESISTANT ADULT AND PEDIATRIC PRIMARY FOCAL SEGMENTAL GLOMERULOSCLEROSIS USING THE LIPOSORBER® LA-15 SYSTEM). SITE REPORTED THE PATIENT HAD THE SAES ON (B)(6) 2023 AFTER THE LAST TREATMENT GIVEN ON (B)(6) 2022, WHICH WAS LEARNED DURING THE 12MONTHS FOLLOWUP VISIT ON (B)(6) 2023. SITE REPORTED PATIENT HAD SEPSIS, COLSTRIDIUM DIFFICILE, E. COLI, URINARY TRACT INFECTION. PATIENT WAS HOSPITALIZED FROM (B)(6) 2023 AND GIVEN CEFUROXIME, VANCOMYCIN, CEFTRIAXONE. THE EVENT OCCURRED OVER TEN MONTHS AFTER THE LAST LIPOSORBER TREATMENT. THE SAE WAS DETERMINED BY THE PHYSICIAN TO BE UNRELATED TO LIPOSORBER TREATMENT.

  Patient problems: Sepsis; Urinary Tract Infection

  MAUDE report 21414730 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (MFR#3002808904-2025-00007): THE INFORMATION FOR THIS CASE WAS COLLECTED IN THE POST-APPROVAL STUDY (TREATMENT OF DRUG-RESISTANT ADULT AND PEDIATRIC PRIMARY FOCAL SEGMENTAL GLOMERULOSCLEROSIS USING THE LIPOSORBER® LA-15 SYSTEM) AT ONE-MONTH FOLLOW-UP VISIT. TREATMENT USING OUR PRODUCT WAS PERFORMED WITHOUT PROBLEMS ON (B)(6) 2024. THE PATIENT CAME TO (B)(6) ON (B)(6) 2024 AND REPORTED HEADACHE FOR 3 DAYS. A BLOOD DRAW IN THE CLINIC SHOWED A SERUM CREATININE OF 1.9. THE PATIENT WAS ADMITTED TO THE HOSPITAL DIRECTLY FROM THE CLINIC FOR ACUTE KIDNEY INJURY (AKI) AND TO RULE OUT MENINGITIS. THE PATIENT WAS STARTED ON AGGRESSIVE IV FLUIDS AND EMPIRIC ANTIBIOTICS FOR POSSIBLE MENINGITIS. FOUND TO HAVE GROWTH OF E.COLI ON 1/2 BLOOD CULTURES, SUSCEPTIBLE TO CEFTRIAXONE. BLOOD CULTURES FROM CENTRAL LINE AND PERIPHERAL LINE SHOWED NO GROWTH. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS FOR SEPSIS. HEADACHES NOTED TO IMPROVE, AND CREATININE STAYED BETWEEN 1.6 AND 1.9. THE PATIENT DISCHARGED ON (B)(6) 2024. THE PHYSICIAN IN CHARGE CONSIDERS THE AKI AND THE HEADACHE WERE SIMPLY ADVERSE EVENTS THAT WERE A RESULT OF THE SEPSIS DUE TO E.COLI (SAE). THE PATIENT DEVELOPED SEPSIS BECAUSE THE PATIENT I

  Patient problems: Kidney injury; Sepsis

  MAUDE report 21414616 ↗
• DeathFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEATH OF AN 8-YEAR-OLD FSGS PATIENT WAS REPORTED. (MFR#3002808904-2025-00005). THIS WAS AN 8-YEAR-OLD GIRL WHO WAS DIAGNOSED WITH NEPHROTIC SYNDROME WITH ACUTE KIDNEY INJURY AND HYPERTENSION ON (B)(6) 2022. A RENAL BIOPSY ON (B)(6) 2022 SHOWED COLLAPSING GLOMERULOPATHY. SHE REQUIRED INITIATION OF HEMODIALYSIS ON (B)(6) 2022 FOR UREMIA AND FLUID OVERLOAD. SHE REMAINED DIALYSIS DEPENDENT. HEMODIALYSIS WAS PERFORMED AT DAVITA 3X / WK ON MONDAYS, WEDNESDAYS, AND FRIDAYS UNDER THE DIRECTION OF CEDARS PEDIATRIC NEPHROLOGISTS. SHE WAS RESISTANT TO STEROIDS AND RITUXIMAB. CALCINEURIN INHIBITORS WERE NOT GIVEN DUE TO POOR RENAL FUNCTION. LDL APHERESIS WAS STARTED WITHOUT PROBLEMS FOR REFRACTORY FSGS ON (B)(6) 2022. ON (B)(6) 2022, SHE UNDERWENT THE 10TH TREATMENT OUT OF 12 TREATMENTS WITHOUT PROBLEMS. SHE WAS GIVEN SOLUMEDROL PER PROTOCOL. SHE RECEIVED HEMODIALYSIS TREATMENTS AT DAVITA ON (B)(6) 2022. THEY WERE UNEVENTFUL. THE NEXT HEMODIALYSIS WAS SCHEDULED ON (B)(6) 2022. ON (B)(6) 2022 AT 1:25 AM, THE PATIENT PRESENTED AT KP LAMC ED FOR SHORTNESS OF BREATH. THE PARENT REPORTED THAT HE WAS GETTING THE PATIENT READY FOR BED AND NOTED THE INCREASED WORK OF BREATHING SO THE PATIENT WAS BROUG

  Patient problems: Pulmonary Edema

  MAUDE report 21413997 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INFORMATION FOR THIS CASE WAS COLLECTED IN THE POST-APPROVAL STUDY (TREATMENT OF DRUG-RESISTANT ADULT AND PEDIATRIC PRIMARY FOCAL SEGMENTAL GLOMERULOSCLEROSIS USING THE LIPOSORBER? LA-15 SYSTEM). SITE REPORTED THE PATIENT HAD THE SAES ON (B)(6) 2023 AFTER THE LAST TREATMENT GIVEN ON (B)(6), 2022, WHICH WAS LEARNED DURING THE 12MONTHS FOLLOWUP VISIT ON (B)(6) 2023. SITE REPORTED PATIENT HAD SEPSIS, COLSTRIDIUM DIFFICILE, E. COLI, URINARY TRACT INFECTION. PATIENT WAS HOSPITALIZED FROM (B)(6)2023 AND GIVEN CEFUROXIME, VANCOMYCIN, CEFTRIAXONE. THE EVENT OCCURRED OVER TEN MONTHS AFTER THE LAST LIPOSORBER TREATMENT. THE SAE WAS DETERMINED BY THE PHYSICIAN TO BE UNRELATED TO LIPOSORBER TREATMENT.

  Patient problems: Sepsis; Urinary Tract Infection

  MAUDE report 21400185 ↗
• DeathFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEATH OF AN 8-YEAR-OLD FSGS PATIENT WAS REPORTED. THIS WAS AN 8-YEAR-OLD GIRL WHO WAS DIAGNOSED WITH NEPHROTIC SYNDROME WITH ACUTE KIDNEY INJURY AND HYPERTENSION ON (B)(6) 2022. A RENAL BIOPSY ON (B)(6) 2022 SHOWED COLLAPSING GLOMERULOPATHY. SHE REQUIRED INITIATION OF HEMODIALYSIS ON (B)(6) 2022 FOR UREMIA AND FLUID OVERLOAD. SHE REMAINED DIALYSIS DEPENDENT. HEMODIALYSIS WAS PERFORMED AT DAVITA 3X / WK ON MONDAYS, WEDNESDAYS, AND FRIDAYS UNDER THE DIRECTION OF CEDARS PEDIATRIC NEPHROLOGISTS. SHE WAS RESISTANT TO STEROIDS AND RITUXIMAB. CALCINEURIN INHIBITORS WERE NOT GIVEN DUE TO POOR RENAL FUNCTION. LDL APHERESIS WAS STARTED WITHOUT PROBLEMS FOR REFRACTORY FSGS ON (B)(6) 2022. ON (B)(6) 2022, SHE UNDERWENT THE 10TH TREATMENT OUT OF 12 TREATMENTS WITHOUT PROBLEMS. SHE WAS GIVEN SOLUMEDROL PER PROTOCOL. SHE RECEIVED HEMODIALYSIS TREATMENTS AT DAVITA ON (B)(6) 2022. THEY WERE UNEVENTFUL. THE NEXT HEMODIALYSIS WAS SCHEDULED ON (B)(6) 2022. ON (B)(6) 2022 AT 1:25 AM, THE PATIENT PRESENTED AT KP LAMC ED FOR SHORTNESS OF BREATH. THE PARENT REPORTED THAT HE WAS GETTING THE PATIENT READY FOR BED AND NOTED THE INCREASED WORK OF BREATHING SO THE PATIENT WAS BROUGHT TO THE ED. HER O2 SATURATI

  Patient problems: Pulmonary Edema

  MAUDE report 21397744 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INFORMATION FOR THIS CASE WAS COLLECTED IN THE POST-APPROVAL STUDY (TREATMENT OF DRUG-RESISTANT ADULT AND PEDIATRIC PRIMARY FOCAL SEGMENTAL GLOMERULOSCLEROSIS USING THE LIPOSORBER? LA-15 SYSTEM) AT ONE-MONTH FOLLOW-UP VISIT. TREATMENT USING OUR PRODUCT WAS PERFORMED WITHOUT PROBLEMS ON (B)(6) 2024. THE PATIENT CAME TO NEPHROLOGY CLINIC AT (B)(6) ON (B)(6) 2024 AND REPORTED HEADACHE FOR 3 DAYS. A BLOOD DRAW IN THE CLINIC SHOWED A SERUM CREATININE OF 1.9. THE PATIENT WAS ADMITTED TO THE HOSPITAL DIRECTLY FROM THE CLINIC FOR ACUTE KIDNEY INJURY (AKI) AND TO RULE OUT MENINGITIS. THE PATIENT WAS STARTED ON AGGRESSIVE IV FLUIDS AND EMPIRIC ANTIBIOTICS FOR POSSIBLE MENINGITIS. FOUND TO HAVE GROWTH OF E.COLI ON 1/2 BLOOD CULTURES, SUSCEPTIBLE TO CEFTRIAXONE. BLOOD CULTURES FROM CENTRAL LINE AND PERIPHERAL LINE SHOWED NO GROWTH. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS FOR SEPSIS. HEADACHES NOTED TO IMPROVE, AND CREATININE STAYED BETWEEN 1.6 AND 1.9. THE PATIENT DISCHARGED ON (B)(6) 2024. THE PHYSICIAN IN CHARGE CONSIDERS THE AKI AND THE HEADACHE WERE SIMPLY ADVERSE EVENTS THAT WERE A RESULT OF THE SEPSIS DUE TO E.COLI (SAE). THE PATIENT DEVELOPED SEPSIS BECAUSE THE PATIENT IS IMMUNO

  Patient problems: Kidney injury; Sepsis

  MAUDE report 21397561 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT AT THE 22 WEEK OF GESTATION. INITIAL BOLUS OF APPROXIMATELY 3500 IU OF SODIUM HEPARIN (SUBSEQUENT CONTINUOUS INFUSION AT 0,1 ML / HOUR). START OF TREATMENT WITH BLOOD FLOW 50 ML / MIN - PLASMA FLOW 15 ML / MIN. AT APPROXIMATELY 50 ML OF TREATED PLASMA ONSET OF SKIN FLUSHING, TACHYCARDIA AND HEADACHE. THIS REQUIRED ZEROING THE PLASMA PUMP AND ADMINISTERING IV SALINE WITH REGRESSION OF SYMPTOMS IN ABOUT 5 MINUTES. THE TREATMENT THEN CONTINUED WITH EXTRACTION AT 5-7% AND BLOOD FLOW OF 30-40 ML / MIN BASED ON THE CLINICAL SYMPTOMS PRESENTED BY THE PATIENT. AT 700 ML OF TREATED PLASMA SUDDEN COAGULATION IN THE DISPOSABLE. PREMATURE TERMINATION OF THE TREATMENT WITH BLOOD / PLASMA LOSS.

  Patient problems: Anaphylactoid / Anaphylaxis; Hypersensitivity/Allergic reaction

  MAUDE report 15822448 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE PATIENT'S FIFTH LIPOSORBER TREATMENT WAS COMPLETED ON (B)(6) 2022. THE SITE REPORTED NO DEVICE ISSUES OR COMPLICATIONS DURING TREATMENT. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2022 DUE TO ACUTE KIDNEY INJURY AND WAS RELEASED WHEN RECOVERED. PATIENT ALSO WAS REPORTED TO HAVE SHORTNESS OF BREATH AND CHEST PAIN WHICH WERE ASSESSED AS NOT RELATED TO LIPOSORBER TREATMENT BY THE PHYSICIAN. THE ACUTE KIDNEY INJURY RELATIONSHIP TO TREATMENT WITH LIPOSORBER WAS ASSESSED AS UNKNOWN. HOWEVER, THE PHYSICIAN HAS CONTINUING THE PATIENT ON LIPOSORBER TREATMENTS.

  Patient problems: Unspecified Kidney or Urinary Problem

  MAUDE report 15435433 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PEDIATRIC PATIENT DEVELOPED FOCAL SEGMENTAL GLOMERULAR SCLEROSIS (FSGS) WITH STEROID RESISTANT NEPHROTIC SYNDROME. A TUNNELED. CATHETER FOR BLOOD WITHDRAWING WAS PLACED AT RIGHT INTERNAL JUGULAR VEIN ON (B)(6) 2017 FOR COMMENCING LDL-APHERESIS USING. THE LIPOSORBER LA-15 SYSTEM. THE LDL-APHERESIS UP TO 9TH ON (B)(6) WAS CONDUCTED WITHOUT ANY PROBLEM IN OUT-PATIENT BASIS. SINCE THE PATIENT HAD FEVER ON THE NEXT DAY OF 9TH LDL-APHERESIS, SHE WAS ADMITTED TO THE HOSPITAL FOR FURTHER EXAMINATION AND MEDICATION. HER WBC WAS 34200/MICROLITER AND THE RESULT OF THE BLOOD CULTURE WAS ESCHERICHIA COLI POSITIVE, WHICH WAS FOUND TO BECOME NEGATIVE AFTER ADMINISTRATION OF ANTIBIOTICS. THE 12TH LDL-APHERESIS, THE FINAL SESSION, ON (B)(6) WAS OVER WITHOUT ANY PROBLEM. THE ATTENDING PHYSICIAN WAS PLANNING TO DISCHARGE THE PATIENT AFTER REMOVING THE CATHETER. MFR REPORT #: 3002808904-2017-00005.

  Patient problems: Fever

  MAUDE report 11635097 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, PATIENT RECEIVED TREATMENT WITH LIPOSORBERLA-15 SYSTEM. THE TREATMENT WAS COMPLETED. AT 4:00PM THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ANASARCA WITH WORSENING AKI EXACERBATED BY DEHYDRATION IN THE SETTING OF ELEVATED CYCLOSPORINE LEVELS. THE SITE NOTED THAT THE SAE IS POSSIBLY RELATED TO THE TREATMENT AND THAT THE DEVICE DID NOT MALFUNCTION. ON 11/23/2020, THE SITE REPORTED THE SAE, CLASSIFIED THE ADVERSE EVENT AS SERIOUS, AND NOTED THAT THE PATIENT WAS STILL HOSPITALIZED. ON 11/30/2020 USER FACILITY REPORTED LA-15 SYSTEM LOT AND SERIAL NUMBERS. THEY REPORTED THAT THE ADVERSE EVENT HAS ENDED ON (B)(6) 2020 AND THAT THE PATIENT WOULD BE CONTINUING TREATMENT WITH THE LIPOSORBER SYSTEM. USER FACILITY REPORTED ACTIONS TAKEN TO TREAT ADVERSE EVENT AS THE FOLLOWING MEDICATIONS; CYCLOSPORINE HELD, FLUCONAZOLE HELD, LASIX ORAL AND IV, AND 25% ALBUMIN.

  Patient problems: Dehydration; Swelling/ Edema; Unspecified Kidney or Urinary Problem

  MAUDE report 11044208 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) Y.O BOY WITH RECURRENT FSGS POST-TRANSPLANT. HAS BEEN RECEIVING PLASMAPHERESIS UP UNTIL TODAY. GFR WELL BELOW 60 BUT A MOOT POINT IN POST-TRANSPLANT; SERUM CREATININE 2.9; SERUM PROTEIN 4.6; ALBUMIN 3.5; H&H 9.2, 28.6; 305 PLATELETS. HE WAS ON ACE-I (ENALAPRIL) AND OFF FOR 72 HOURS ACCORDING TO HIS MOTHER. HE HAD A DOUBLE LUMEN IJ PATENT WITH GOOD FLOWS. PLASMA VOLUME TB TREATED 4,200 ML (90KG X 60ML). 1.8 U HEPARIN FOR BOLUS AND 1.8 U HEPARIN DURING TREATMENT (25 U PER KG). TWO ALARMS EARLY ON FOR VENOUS PRESSURE WHICH WERE QUICKLY REMEDIED WITH A FLUSH. HIS MOTHER STATES THAT ONE OF THE PORTS WAS NOT WORKING WELL AND THE NURSES DOING THE PLASMAPHERESIS ONLY USED ONE OF THE PORTS. STARTED AT 60ML BFR AND 20% PFR. TREATMENT STARTED AT 09:48 VSS 125/76-84-16 SKIN WARM, AND DRY COLOR NORMAL AT 10:04, 16" INTO TREATMENT, PATIENT COMPLAINED OF CHEST PAIN AND STARTED THRASHING IN THE BED; COLOR PALE LIPS CYANOTIC EVEN THOUGH PULSE OX 100%. THE PATIENT WAS LOWERED THE HEAD OF THE BED GOT O2 NON REBREATHER MASK; STOPPED THE PUMPS HAD RN GIVE 100 CC BOLUS NORMAL SALINE (NS); CODE CALLED AND NURSES GAVE SOLU MEDROL 125 AND DR. WANTED 500 CC BOLUS NS GIVEN. VS WERE 154/84-129-24. PA

  Patient problems: Chest Pain; Dyspnea; High Blood Pressure/ Hypertension; Tachycardia

  MAUDE report 11036533 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CASE IS A PATIENT WITH FAMILIAL HYPERCHOLESTEROLEMIA AND HYPER-LP (A)EMIA. DURING THE SECOND LA-15 TREATMENT THE PATIENT TEMPORARILY BROKE AWAY FROM LA-15 TREATMENT DUE TO TOILET, AND THE BLOOD PRESSURE DECREASED (98 / 56MMHG) AND THE PATIENT LOST CONSCIOUSNESS. THE BLOOD PRESSURE RECOVERED TO 124/68 AND THEREAFTER LA-15 TREATMENT WAS RESUMED. LA-15 TREATMENT WAS DISCONTINUED AT A PLASMA TREATMENT VOLUME OF 3.8 L ALTHOUGH THE TARGET VOLUME WAS SET TO 4.45L. THE FIRST LA-15 TREATMENT WAS CONDUCTED TWO WEEKS BEFORE THE SECOND TREATMENT. ALTHOUGH MILD DECREASE IN THE BLOOD PRESSURE TO 90'S, FEELING OF FAINT AND NAUSEA DURING THE TREATMENT WERE OBSERVED. THE TARGET PLASMA TREATMENT VOLUME 4.4L WAS ACCOMPLISHED. CONCOMITANT MEDICATIONS: LISINOPRIL (ACE-INHIBITOR) WAS WITHDREW 6 DAYS BEFORE THE FIRST LA-15 TREATMENT. PLAVIX (ANTIPLATELET DRUG) ZETIA (CHOLESTEROL LOWERING DRUG) MFR# 3002808904-2020-00005.

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

  MAUDE report 11036530 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CASE IS A PATIENT WITH FAMILIAL HYPERCHOLESTEROLEMIA AND HYPER-LP (A)EMIA. DURING THE SECOND LA-15 TREATMENT THE PATIENT TEMPORARILY BROKE AWAY FROM LA-15 TREATMENT DUE TO TOILET, AND THE BLOOD PRESSURE DECREASED (98 / 56MMHG) AND THE PATIENT LOST CONSCIOUSNESS. THE BLOOD PRESSURE RECOVERED TO 124/68 AND THEREAFTER LA-15 TREATMENT WAS RESUMED. LA-15 TREATMENT WAS DISCONTINUED AT A PLASMA TREATMENT VOLUME OF 3.8 L ALTHOUGH THE TARGET VOLUME WAS SET TO 4.45L. THE FIRST LA-15 TREATMENT WAS CONDUCTED TWO WEEKS BEFORE THE SECOND TREATMENT. ALTHOUGH MILD DECREASE IN THE BLOOD PRESSURE TO 90'S, FEELING OF FAINT AND NAUSEA DURING THE TREATMENT WERE OBSERVED. THE TARGET PLASMA TREATMENT VOLUME 4.4L WAS ACCOMPLISHED. CONCOMITANT MEDICATIONS: LISINOPRIL (ACE-INHIBITOR) WAS WITHDREW 6 DAYS BEFORE THE FIRST LA-15 TREATMENT. PLAVIX (ANTIPLATELET DRUG) ZETIA (CHOLESTEROL LOWERING DRUG).

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

  MAUDE report 9838946 ↗