CLEARUM HS IBP4373Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08051736004161), received between Aug 23, 2024 and Mar 18, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Biocompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2025Leak/Splash; Protective Measures Problem; Leak/Splash; Protective Measures Problem

  ACCORDING TO THE REPORTER, FIFTEEN MINUTES TO ONE HOUR AFTER THE START OF THE HDF (HEMODIAFILTRATION) TREATMENT, BLOOD LEAKAGE WAS OBSERVED WITHIN THE REPORTED FILTER. THIS WAS NOT ASSOCIATED WITH AN HRF (HEMODIAFILTRATION REINFUSION) FILTER. A BLOOD LEAKAGE (BLD) ALARM WAS TRIGGERED AFTER THIRTY MINUTES. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. PRIMING WAS DONE WITH NORMAL RESULTS. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. AS A RESULT, THE EXTRACORPOREAL KIT AND DIALYZER HAD TO BE REPLACED WITH A NEW ONE FROM THE SAME PRODUCT ID (IDENTIFIER) AND LOT NUMBER ON THE DAY OF THE EVENT, WITHOUT RETURNING BLOOD TO THE PATIENT. THE TREATMENT WAS COMPLETED AFTER THE REMEDIAL ACTION. THE PATIENT WAS ADMINISTERED A DRUG DUE TO THE EVENT. A TOTAL OF 300 MILLILITERS (ML) OF BLOOD WAS LOST, BUT NO BLOOD TRANSFUSION WAS PERFORMED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21632596 ↗
• InjurySep 5, 2024Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DUE TO RENAL FAILURE, THE PATIENT REGULARLY MAINTAINED HEMODIALYSIS AT THE DEPARTMENT AT 9:00 A.M. ON THE DAY OF THE EVENT, THE PATIENT UNDERWENT HEMODIALYSIS PERFUSION THERAPY. AFTER TWO HOURS OF TREATMENT, IT WAS FOUND THAT THERE WAS AN 8 CM (CENTIMETER) LONG CRACK BETWEEN THE SEALING RING AT THE ARTERY END OF THE FILTER SHELL AND THE FILTER BODY, AND SOME DIALYSATE EXTRAVASATED. THE DIALYZER WAS USED IN COMBINATION WITH DISPOSABLE HEMODIALYSIS TUBING. PRIMING WAS DONE WITH A NORMAL RESULT. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. THE PATIENT DID NOT COMPLAIN OF DISCOMFORT. THE PATIENT WAS GIVEN A 0.9% SODIUM CHLORIDE INJECTION OF 300 ML (MILLILITERS) FOR BLOOD RETURN/RECOVERY AS A RESULT OF THE EVENT. THERE WERE NO COMPONENTS REPLACED. THE FILTER WAS REPLACED. THE TREATMENT WAS CONTINUED AFTER CHANGING THE MEDICAL EQUIPMENT. AFTER SYMPTOMATIC TREATMENT, NO ABNORMALITIES OCCURRED THROUGHOUT THE DIALYSIS TREATMENT, THE DIALYSIS TREATMENT ENDED SUCCESSFULLY, AND THE PATIENT DID NOT COMPLAIN OF SPECIAL DISCOMFORT. THERE WAS AN UNSPECIFIED AMOUNT OF BLOOD LOSS. A BLOOD TRANSFUSION WAS NOT PERFORMED. THE PATIENT W

  Patient problems: Insufficient Information

  MAUDE report 20151634 ↗
• InjuryAug 23, 2024Biocompatibility; Biocompatibility

  ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, THE BLOOD PURIFICATION CENTER NURSE WAS TREATING THE PATIENT WITH A DIALYZER. IT WAS STATED THAT DURING DIALYSIS, THE PATIENT EXPERIENCED DIZZINESS, WITH BLOOD PRESSURE (BP): 159/94 MMHG AND P: 71 TIMES/MINUTE. THERE WAS NO ALARM/ERROR CODE ACTIVATED/DISPLAYED. PRIMING WAS DONE WITH A NORMAL RESULT. THE REPORTING PHYSICIAN GAVE DEXAMETHASONE INTRAVENOUSLY AS A REMEDIAL ACTION, AND THE SYMPTOMS WERE RELIEVED. THE ISSUE WAS ALSO REPORTED TO THE SUPPLIES OFFICE. THE PROCEDURE WAS CONTINUED AND COMPLETED AFTER THE REMEDIAL ACTION WAS DONE. THERE WAS NO BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT PERFORMED.

  Patient problems: Dizziness; High Blood Pressure/ Hypertension

  MAUDE report 20055557 ↗