CombiSet 03-2630-6Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840861100248), received between Feb 11, 2020 and Feb 11, 2020 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K962081); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH RENAL FAILURE ON HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) FELT UNWELL DURING THEIR HD TREATMENT ON (B)(6) 2020. THE PATIENT WAS REPORTEDLY IN THE ACUTE DIALYSIS UNIT AT A HOSPITAL, TRANSPORTED FROM THE REHABILITATION DEPARTMENT. UPON EVALUATION, IT WAS DISCOVERED THAT THE PATIENT¿S VENOUS FISTULA NEEDLE DISLODGED, AND THE PATIENT SUSTAINED BLOOD LOSS OF APPROXIMATELY 1 L. THE NEEDLE TIP WAS SITTING AGAINST THE PATIENT¿S SKIN. THE MACHINE, A FRESENIUS 2008T HEMODIALYSIS SYSTEM, DID NOT ALARM. THE NEEDLE WAS CONNECTED TO A FRESENIUS CUSTOM COMBI SET, WHICH WAS REPORTEDLY DISCARDED AFTER USE. THE PATIENT WAS GIVEN 1 L OF NORMAL SALINE AND WAS ADMITTED FOR THE TRANSFUSION OF 2 UNITS OF PACKED RED BLOOD CELLS (PRBCS). THE PATIENT WAS HOSPITALIZED OVERNIGHT AND DISCHARGED ON (B)(6) 2020. SUBSEQUENT ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE THUS FAR PROVEN UNSUCCESSFUL.

  Patient problems: Blood Loss; Hypovolemia; Low Blood Pressure/ Hypotension; Syncope

  MAUDE report 9696505 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962081. One submission often covers many models, so check the product and lot details in each record.

• Z-0843-2011 · Nov 19, 2010 · Terminated
  Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9
• Z-0844-2011 · Nov 19, 2010 · Terminated
  Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7