CLEARUM HS IBP4370Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08051736004130), received between Aug 21, 2023 and Aug 21, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Biocompatibility” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2023Coagulation in Device or Device Ingredient; Biocompatibility; Coagulation in Device or Device Ingredient; Biocompatibility

  ACCORDING TO THE REPORTER, 30 MINUTES AFTER THE START OF RRT (RENAL REPLACEMENT THERAPY), ALLERGIC SYMPTOMS WERE NOTED (SIGNIFICANT DECREASE IN BLOOD PRESSURE, SIGNIFICANT CHANGE IN WHITE BLOOD CELL COUNT, AND PLATELET COUNT), COAGULATION IN THE CIRCUIT OR COLUMN, MARKED RESIDUAL BLOOD, ETC. IT WAS ALSO STATED THAT THE PATIENT HAD VOMITED. QB (BLOOD FLOW RATE) WAS 150ML/MIN, QD (DIALYSIS FLUID FLOW RATE) WAS 500ML/MIN, AND QF (ULTRAFILTRATION RATE) WAS 33.3 ML/MIN. NO PREVIOUS IMPLEMENTATION CONDITIONS OR CHANGES WERE MADE AT THE START OF THE USE OF THE PRODUCT. THE COMPETITOR'S PRODUCT WAS USED BEFORE SWITCHING TO THE NEW ONE. THERE WAS NO ALARM ACTIVATED. NO VISIBLE DAMAGE OR DEFECTS WERE FOUND ON THE PRODUCT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. HDF (HEMODIAFILTRATION) MEMBRANE REPLACEMENT WAS THE MEDICAL INTERVENTION; BLOOD PRESSURE INCREASED, FEELINGS OF DISCOMFORT DISAPPEARED, AND THE TREATMENT WAS COMPLETED. HEPARIN (INITIAL (B)(4) UNITS, CONTINUOUS (B)(4) UNITS) WAS THE COAGULANT TYPE AND THE MEDICATION GIVEN TO THE PATIENT. NO OTHER INTERVENTION OR TREATMENT WAS REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS. A BLOOD TRANSFUSION WAS NOT REQU

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Local Reaction; Low Blood Pressure/ Hypotension; Vomiting

  MAUDE report 17592245 ↗
• InjuryAug 21, 2023Coagulation in Device or Device Ingredient; Biocompatibility; Coagulation in Device or Device Ingredient; Biocompatibility

  ACCORDING TO THE REPORTER, 15 MINUTES AFTER THE START OF RRT (RENAL REPLACEMENT THERAPY), ALLERGIC SYMPTOMS WERE OBSERVED (SIGNIFICANT DECREASE IN BLOOD PRESSURE, SIGNIFICANT CHANGE IN WHITE BLOOD CELL COUNT AND PLATELET COUNT), COAGULATION IN THE CIRCUIT OR COLUMN, MARKED RESIDUAL BLOOD AND ETC. THE PATIENT ALSO HAD CHEST DISCOMFORT. QB (BLOOD FLOW RATE) WAS 200 ML/MINUTE, QD (DIALYSATE FLOW RATE) WAS 500 ML/MINUTE AND QF (INFUSION FLOW RATE) WAS 1666 ML/MINUTE. IT WAS STATED THAT COMPETITOR'S PRODUCT (CTA COATING) WAS USED BEFORE SWITCHING TO THE FILTER. THERE WERE NO PREVIOUS IMPLEMENTATION CONDITIONS OR CHANGES MADE AT THE START OF THE USE OF THE DEVICE. THERE WAS NO INFORMATION ON ALARMS DURING USE OR NO ALARMS WERE ACTIVATED. INITIAL DOSE OF 300MG ANTICOAGULANT WAS ADMINISTERED TO THE PATIENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, NO DAMAGES WERE NOTED ON THE PRODUCT AND PRIMING WAS DONE WITH NORMAL RESULT. THERE WERE NO LABORATORY TESTS PERFORMED. AFTER FLUID REPLACEMENT, THE CONDITION WAS ALLEVIATED AND THE PATIENT WAS MONITORED FOR 30 MINUTES, HOWEVER, THERE WAS NO INCREASE IN BLOOD PRESSURE. THE ANTICOAGULANT NAFAMOSTAT OR (NM) WAS SUSPECTED AND H

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Local Reaction; Low Blood Pressure/ Hypotension

  MAUDE report 17585838 ↗