Dialysate Sack (SAK) with Concentrate SAK-403Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M535SAK4030), received between May 3, 2019 and Aug 29, 2019 — classified as 2 injuries.

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 18, 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 29, 2019Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON (B)(6) 2019 FROM THE CAREGIVER OF A (B)(6) YEAR OLD MALE WITH END STAGE RENAL DISEASE, ANEMIA, AND DIABETES WHO EXPERIENCED NUMBNESS IN HIS ARM, A BURNING SENSATION, AND SHIVERS 40 MINUTES INTO STANDARD HOME HEMODIALYSIS TREATMENT ON (B)(6) 2019. THE PATIENT WAS TAKEN TO HOSPITAL WHERE BLOOD CULTURES SHOWED NO GROWTH. PROPHYLACTIC ANTIBIOTICS (NOS) WERE ADMINISTERED, SYMPTOMS RESOLVED, AND THE PATIENT WAS DISCHARGED (B)(6) 2019.

  Patient problems: Burning Sensation; Numbness; Reaction; Shaking/Tremors

  MAUDE report 8945647 ↗
• InjuryMay 3, 2019Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON (B)(6) 2019 FROM THE HOME THERAPY NURSE (HTN) OF A (B)(6) MALE WITH MULTIPLE COMORBIDITIES INCLUDING END-STAGE RENAL DISEASE (ESRD) AND ELEVATED LIVER FUNCTION TESTS (LFT), WHO EXPERIENCED HEADACHE, FEVER (104.5 F), TACHYCARDIA (117 BPM), NUMBNESS/TINGLING IN HIS FINGERS, LOWER BACK PAIN, CHILLS, HYPOTENSION (98/58), AND INCREASED LETHARGY APPROXIMATELY 50 MINUTES AFTER INITIATING HIS FIRST IN-CENTER HEMODIALYSIS TREATMENT WITH THE DIALYSATE SACK ON (B)(6) 2019. THERAPY WAS TERMINATED, INTRAVENOUS (IV) VANCOMYCIN (1.5G) & CEFTAZIDIME (1.5G) WERE ADMINISTERED, AND THE PATIENT BECOME UNRESPONSIVE. NASAL OXYGEN (O2) WAS APPLIED, AND THE PATIENT WAS TRANSPORTED VIA AMBULANCE AND ADMITTED TO THE INTENSIVE CARE UNIT (ICU). ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019 FROM THE HTN REVEALED THAT EVALUATION IN HOSPITAL INCLUDED BLOOD AND STOOL CULTURES WITH NO ORGANISM IDENTIFIED. VIRAL SYNDROME WAS SUSPECTED, AND THE IV ANTIBIOTICS WERE CEASED. FURTHER BLOOD TESTS, ELECTROCARDIOGRAM (EKG) AND CHEST X-RAY (CXR) REVEALED NO CAUSATIVE FACTORS. THE PATIENT RECEIVED A DIAGNOSIS OF SEPSIS WITH ACUTE ORGAN DYSFUNCTION AND WAS DISCHARGED IN STABLE CONDITION ON (B)(6) 201

  Patient problems: Chills; Fever; Headache; Lethargy; Low Blood Pressure/ Hypotension; Numbness; Tachycardia; Tingling; Unspecified Infection

  MAUDE report 8579662 ↗