HMB32 MD042Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 38051411600061), received between Mar 15, 2021 and Mar 25, 2021 — classified as 4 injuries.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2021Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THE SERUM PHOSPHATE LEVEL WAS AS LOW AS 1.7 (HYPOPHOSPHATEMIA). THERE WERE NO OTHER DIAGNOSTIC PROCEDURES PERFORMED. IT DID NOT RESULT TO THE PATIENT BEING HOSPITALIZED AND THE PATIENT WAS NOT TREATED WITH AN ADDITIONAL CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) SESSION. IT DID NOT HAVE MECHANICAL VENTILATION ADDED OR SETTINGS ADJUSTED, THERE WAS NO TREATMENT WITH EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) INITIATED OR ADJUSTED, IT WAS NOT TREATED WITH BLOOD PRODUCTS ADMINISTRATION. THERE WAS NO BLOOD LOSS. SODIUM PHOSPHATE BOLUS WAS ADMINISTERED. THERE WERE NO OTHER ACTIONS TAKEN IN RESPONSE TO THE EVENT. THE PATIENT'S STATUS AT THE TIME OF THE EVENT WAS RECOVERED. IT WAS LATER REPORTED THAT THE MACHINE WAS PREFORMING AS EXPECTED. THE ORDERING PRESCRIPTION WAS WHAT WAS INFLUENCING THE ELECTROLYTES MOST. THE PATIENT IS DECEASED AND IT WAS UNRELATED TO THE DEVICE.

  Patient problems: Electrolyte Imbalance

  MAUDE report 11570932 ↗
• InjuryMar 19, 2021Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD AN INTERMITTENT HYPOKALEMIA THROUGHOUT THE HEMODIALYSIS TREATMENT. PATIENT WAS ON FUROSEMIDE ON 1/23 (5MG) AND 1/24 (13.5MG). IT WAS STATED THAT DIAGNOSTIC TESTS WERE PERFORMED BUT NO DIAGNOSTIC PROCEDURE PERFORMED. THE EVENT RESULTED IN PATIENT¿S TREATMENT BUT NO ADDITIONAL CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) SESSION WITH THE MACHINE. THE PATIENT WAS NOT TREATED WITH ADDITIONAL MECHANICAL VENTILATION OR SETTINGS ADJUSTED, NO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) INITIATED OR ADJUSTED, NOT TREATED WITH BLOOD PRODUCTS. IT WAS STATED THAT THE PATIENT WAS GIVEN AN UNSPECIFIED DOSAGE OF POTASSIUM CHLORIDE BOLUSES AND WAS ALSO ADDED TO DIALYSIS FLUID. THERE WAS NO OTHER MEDICATION GIVEN TO THE ASIDE FROM WHAT WAS MENTIONED. THE PROCEDURE WAS COMPLETED AND THE BLOOD WAS SAFELY RETURNED TO THE PATIENT. THERE WAS NO COMPONENT REPLACED. THERE WAS AN UNSPECIFIED MACHINE ALARM ACTIVATED. THE EVENT DID NOT LEAD TO DEATH, SERIOUS DETERIORATION IN THE HEALTH THAT RESULTED IN LIFE THREATENING ILLNESS OR INJURY, AND PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR BODY FUNCTION. THE EVENT DID NOT LEAD TO PATIENT¿S HOSPITALIZATION, MEDICAL OR SURGI

  Patient problems: Electrolyte Imbalance

  MAUDE report 11526966 ↗
• InjuryMar 16, 2021Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD A DECREASED POTASSIUM LEVELS (HYPOKALAEMIA). IT WAS SAID THAT THE SUBJECT WAS ON FUROSEMIDE/LASIX, WHICH WAS KNOWN TO AFFECT POTASSIUM. MACHINE WAS PERFORMING AS INTENDED. THE AE (ADVERSE EVENT) HAD RESULTED TO A TREATMENT/MEDICATION WITH (ADJUSTED, ADDED, OR DOSE REDUCED) POTASSIUM CHLORIDE BOLUS AND 2 MILLIEQUIVALENT (MEQ) OF POTASSIUM CHLORIDE WAS ADDED TO DIALYSIS FLUID. IT WAS SAID THAT DIAGNOSTIC TESTS WERE PERFORMED SUCH AS SERUM POTASSIUM WHICH WAS 2.2 AND THE POC (POINT-OF-CARE) POTASSIUM WHICH WAS 2.4 BUT THERE WERE NO DIAGNOSTIC PROCEDURES PERFORMED. THE AE DID NOT RESULT IN THE SUBJECT OF BEING HOSPITALIZED AND THE AE WAS NOT TREATED WITH AN ADDITIONAL CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY) SESSION, NOT TREATED WITH MECHANICAL VENTILATION ADDED OR SETTINGS ADJUSTED, NOT TREATED WITH ECMO (EXTRACORPREAL MEMBRANE OXYGENATION) INITIATED OR ADJUSTED AND NOT TREATED WITH BLOOD PRODUCTS ADMINISTRATION. THE SEVERITY OF THE ADVERSE EVENT (AE) WAS MODERATE. THE ISSUE WAS RESOLVED AND THE PATIENT HAD RECOVERED.

  Patient problems: Electrolyte Imbalance

  MAUDE report 11495142 ↗
• InjuryMar 15, 2021Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, AFTER 2 HOURS OF TREATMENT, THE SERUM PHOSPHATE HAD DECREASED FROM 7.0 TO 2.9 (HYPOPHOSPHATEMIA). IT DID NOT RESULT TO THE PATIENT BEING HOSPITALIZED AND THE PATIENT WAS NOT TREATED WITH AN ADDITIONAL CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) SESSION. IT DID NOT HAVE MECHANICAL VENTILATION ADDED OR SETTINGS ADJUSTED, THERE WAS NO TREATMENT WITH ECMO INITIATED OR ADJUSTED, POTASSIUM PHOSPHATE AND SODIUM PHOSPHATE BOLUSES WERE ADMINISTERED. THERE WERE NO OTHER ACTIONS TAKEN IN RESPONSE TO THE EVENT. THE PATIENT HAD RECOVERED. IT WAS LATER REPORTED THAT THE PATIENT DIED WHILE BEING IN THE STUDY BUT THE PATIENT WAS NOT BEING TREATED WITH THE MACHINE SYSTEM AT THE TIME OF DEATH. THE PATIENT WAS DECEASED AND IT WAS UNRELATED TO THE DEVICE. THE CAUSE OF THE DEATH OF THE PATIENT WAS HYPOXEMIC RESPIRATORY FAILURE. THE PATIENT HAD PROGRESSIVE HYPOXEMIC RESPIRATORY FAILURE REQUIRING ESCALATION OF CARE TO THE OSCILLATOR ON (B)(6) 2021. THE PATIENT WAS ON NEAR MAXIMUM OSCILLATOR SETTINGS. ON (B)(6), THE PATIENT'S OXYGEN SATURATIONS LEVELS WAS ACUTELY DROPPED AND AFTER DISCUSSION WITH THE PATIENT'S MEDICAL TEAM AND PARENTS THE DECISION WAS MADE TO WITHDRAW THE CARE.

  Patient problems: Electrolyte Imbalance

  MAUDE report 11489911 ↗