CLEARUM HS IBP4371Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08051736004147), received between Sep 18, 2024 and Jun 13, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Biocompatibility” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2025Biocompatibility; Biocompatibility

  ACCORDING TO THE REPORTER, ON (B)(6) 2025, AT 08:35, THE PATIENT UNDERWENT HEMODIAFILTRATION. INITIAL VITAL SIGNS WERE BLOOD PRESSURE 126/81 MMHG (MILLIMETERS OF MERCURY) AND PULSE 69 BPM (BEATS PER MINUTE). AT 08:59, THE PATIENT EXHIBITED AN ALLERGIC REACTION TO THE HEMODIAFILTER, AND THE PATIENT REPORTED PRURITUS/ITCHING IN BOTH PALMS. PER THE PHYSICIAN'S ORDER, THE SUBSTITUTION FLUID WAS DISCONTINUED, BUT THE SYMPTOMS DID NOT IMPROVE. AT 09:03, GENERALIZED PRURITUS AND RASH DEVELOPED, WORSENING FROM THE INITIAL PRESENTATION. AS AN INITIAL DISPOSITION, CORRESPONDING ANTI-ALLERGY TREATMENTS WERE GIVEN. OXYGEN INHALATION AND INTRAVENOUS ADMINISTRATION OF 5 MG (MILLIGRAMS) OF DEXAMETHASONE WERE ADMINISTERED PER PHYSICIAN'S ORDER, WITH NO IMPROVEMENT. THE EXTRACORPOREAL CIRCUIT WAS DISCONNECTED PER THE PHYSICIAN'S ORDER, AND 25 MG OF PROMETHAZINE WAS ADMINISTERED INTRAMUSCULARLY. VITAL SIGNS AT THIS TIME WERE BLOOD PRESSURE 156/94 MMHG, PULSE 80 BPM, AND SPO2 (PERIPHERAL CAPILLARY OXYGEN SATURATION) 98%. SUBSEQUENTLY, 50 ML (MILLILITERS) OF 10% GLUCOSE INJECTION AND 10 ML OF 10% CALCIUM GLUCONATE WERE ADMINISTERED INTRAVENOUSLY. THE PATIENT'S CONDITION GRADUALLY IMPROVED, AND OBSERVA

  Patient problems: High Blood Pressure/ Hypertension; Hypersensitivity/Allergic reaction; Itching Sensation; Rash

  MAUDE report 22206844 ↗
• InjuryMar 21, 2025Defective Component; Biocompatibility; Connection Problem; Defective Component; Biocompatibility; Connection Problem

  ACCORDING TO THE REPORTER, AT 8:02 AM ON (B)(6) 2025, A PATIENT WITH CHRONIC RENAL INSUFFICIENCY-UREMIA WAS GIVEN HEMODIALYSIS TREATMENT USING A HEMODIALYSIS FILTER. THE EXTRACORPOREAL CIRCULATION LINE WAS GIVEN A 0.9% SODIUM CHLORIDE 1000 ML (MILLILITERS) PRE-FILLED LINE. AFTER THE AIR WAS EXHAUSTED, THE PATIENT WAS PUT ON THE MACHINE FOR HEMODIALYSIS TREATMENT. AT 09:39 P.M., THE PATIENT BEGAN TO EXPERIENCE UNBEARABLE MUSCLE SPASMS IN BOTH LOWER LIMBS. AS ADVISED BY THE DOCTOR, 50% GLUCOSE (20 ML) + 10 ML OF 10% CALCIUM GLUCONATE WAS SLOWLY ADMINISTERED INTRAVENOUSLY. THE DIALYZER WAS FOUND TO BE DAMAGED AND EXUDED. THE BLOOD WAS IMMEDIATELY RETURNED, AND THE DIALYZER WAS REPLACED TO CONTINUE DIALYSIS. AFTER RETURNING BLOOD, THE PATIENT¿S SYMPTOMS WERE ALLEVIATED. THE PATIENT¿S ORIGINAL DIALYSIS PRESCRIPTION SET THE TOTAL AMOUNT OF ULTRAFILTRATION AT 4 HOURS OF TREATMENT TO BE 1500 ML. AT THIS TIME, THE MACHINE SHOWED THAT THE TOTAL AMOUNT OF ULTRAFILTRATION WAS 510 ML, BUT THE PATIENT¿S BODY WEIGHT SHOWED THAT THE ACTUAL ULTRAFILTRATION VOLUME REACHED 1700 ML. AFTER THE PATIENT WAS ON THE MACHINE AGAIN, THE TOTAL AMOUNT OF ULTRAFILTRATION WAS REDUCED TO 800 ML. NO BLOOD TRANSFUS

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 21662837 ↗
• InjuryNov 21, 2024Biocompatibility; Biocompatibility

  ACCORDING TO THE REPORTER, 30 MINUTES INTO HEMODIALYSIS TREATMENT USING A HEMODIALYSIS FILTER, THE PATIENT COMPLAINED OF DIFFICULTY BREATHING OR DYSPNEA. THE PATIENT WAS GIVEN OXYGEN AND DEXAMETHASONE 5 MG (MILLIGRAMS) BOLUS INTRAVENOUSLY. NO ALARM WAS ACTIVATED. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. IT WAS FIVE MINUTES AFTER THE DEXAMETHASONE WAS ADMINISTERED, AND THE PATIENT'S DYSPNEA WAS STILL INTOLERABLE, SO THEY HAD TO REPLACE THE FILTER ON THE SAME DAY TO CONTINUE TREATMENT. IT RESOLVED THE ISSUE AND THE TREATMENT WAS COMPLETED. THERE WERE NO BLOOD TRANSFUSIONS. ASIDE FROM DYSPNEA, THERE WAS NO OTHER PATIENT INJURY OCCURRED.

  Patient problems: Dyspnea

  MAUDE report 20746154 ↗
• InjuryNov 15, 2024Biocompatibility; Biocompatibility

  ACCORDING TO THE REPORTER, ON (B)(6) 2024, THE PATIENT UNDERWENT HEMODIAFILTRATION TREATMENT DUE TO RENAL FAILURE. ON (B)(6) 2024, AT 08:30 A.M., THE PATIENT WAS FOUND TO HAVE POOR DISTAL CIRCULATION OF FOUR LIMBS, AND THE SKIN WAS VISIBLE PLAQUE. DEVICE ADVERSE EVENT WAS NOT RULED OUT; THE TREATMENT WAS STOPPED AT 09:10, AND METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION 40 MG IVGTT AN TI-ALLERGIC REACTION WAS USED. THE PATIENT'S SKIN WAS CYANOTIC, AND SPECKLES COULD BE SEEN ON THE EXTREMITIES. THERE WAS NOTHING UNUSUAL OBSERVED ON THE PRODUCT PRIOR TO USE, AND THERE WERE NO OTHER VISIBLE DEFECTS FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THERE WAS NO ALARM OR CODE THAT WAS DISPLAYED. THE REPORTED PRODUCT WAS REPLACED, AND THE TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT PERFORMED.

  Patient problems: Arteriosclerosis/ Atherosclerosis; Cyanosis; Hypersensitivity/Allergic reaction; Localized Skin Lesion

  MAUDE report 20694746 ↗
• InjurySep 18, 2024Biocompatibility; Biocompatibility

  ACCORDING TO THE REPORTER, A PATIENT WITH UREMIA FOR MANY YEARS WAS TREATED WITH CONTINUOUS HEMODIALYSIS. ON THE DAY OF THE EVENT, THE PATIENT ROUTINELY CAME TO THE HOSPITAL FOR DIALYSIS, AND THE DIALYSIS FILTER AND TUBING WERE NORMAL. PRIMING WAS DONE WITH A NORMAL RESULT, AND AN ANTICOAGULANT WAS ADMINISTERED. THE DIALYSIS STARTED AT 7:33 AM, TEMPERATURE 36.5°C, HEART RATE 75 BEATS/MIN, RESPIRATORY RATE 18 BEATS/MIN, AND BLOOD PRESSURE (BP) 140/93 MMHG. AT 8:10 AM, THE PATIENT SUDDENLY PRESENTED WITH CHEST TIGHTNESS AND AN OBVIOUS COUGH WITHOUT OBVIOUS INDUCEMENT. CONSIDERING THE PATIENT'S BIOCOMPATIBILITY OF THE HIGH MOLECULAR MATERIAL OF THE DIALYZER, DIALYSIS WAS IMMEDIATELY STOPPED, AND THE PATIENT WAS GIVEN BLOOD PRESSURE AND OXYGEN SATURATION. DURING THIS PERIOD, THE PATIENT DID NOT COME OUT. CONSIDERING ANAPHYLACTIC SHOCK, THE PATIENT WAS IMMEDIATELY GIVEN DEXAMETHASONE SODIUM PHOSPHATE INJECTION (5MG) VIA INTRAVENOUS PUSH ACCORDING TO THE DOCTOR'S INSTRUCTIONS. THE HEART RATE WAS 62 BEATS/MIN. AT 08:14, BLOOD PRESSURE WAS MEASURED AT 79/58 MMHG, TEMPERATURE 36.5°C, P90 BEATS/MIN, RESPIRATORY RATE 18 BREATHS/MIN. THE PATIENT COMPLAINED OF ABDOMINAL PAIN, WHICH WAS SEVERE A

  Patient problems: Abdominal Pain; Anaphylactic Shock; Anaphylactoid / Anaphylaxis; Chest Pain; Cough; Low Blood Pressure/ Hypotension

  MAUDE report 20246882 ↗