Alaris 10012213Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885403233685), received between Jul 25, 2019 and Oct 11, 2019 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE SET WAS RECEIVED AS AN UNEXPECTED RETURN WITH A REPORT THAT THE CUSTOMER TESTED (3) EXTENSION SETS, THE USER PRIMED THE EXTENSION SET WITH TAP WATER WHEN THE LEAK WAS NOTICED WITH THE CAP IN PLACE. WHEN THE CAP WAS REMOVED DURING PRIMING THERE WAS NO LEAKS NOTED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT. THE EVENT OCCURRED IN THE NICU.

  Patient problems: No Patient Involvement

  MAUDE report 9179736 ↗
• MalfunctionOct 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE SET WAS RECEIVED AS AN UNEXPECTED RETURN WITH A REPORT THAT THE CUSTOMER TESTED (3) EXTENSION SETS, THE USER PRIMED THE EXTENSION SET WITH TAP WATER WHEN THE LEAK WAS NOTICED WITH THE CAP IN PLACE. WHEN THE CAP WAS REMOVED DURING PRIMING THERE WAS NO LEAKS NOTED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT .THE EVENT OCCURRED IN THE NICU.

  Patient problems: No Patient Involvement

  MAUDE report 9179655 ↗
• MalfunctionOct 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE SET WAS RECEIVED AS AN UNEXPECTED RETURN WITH A REPORT THAT THE CUSTOMER TESTED (3) EXTENSION SETS, THE USER PRIMED THE EXTENSION SET WITH TAP WATER WHEN THE LEAK WAS NOTICED WITH THE CAP IN PLACE. WHEN THE CAP WAS REMOVED DURING PRIMING THERE WAS NO LEAKS NOTED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT. THE EVENT OCCURRED IN THE NICU.

  Patient problems: No Patient Involvement

  MAUDE report 9179654 ↗
• InjuryAug 1, 2019Fluid/Blood Leak

  RECEIVED A COPY OF THE CUSTOMER'S SUS VOLUNTARY EVENT REPORT FROM FDA WHICH STATES, ¿CARE FUSION EXTENSION SET REF # (B)(4) LEAKING BLOOD AT POINT BEHIND PT CONNECTION WHEN PRIMED TO THE END AFFECTED LOTS 19035714, 17116703, 17125852, 19025343". THERE WAS NO CUSTOMER/HOSPITAL NAME, ADDRESS, OR CONTACT PROVIDED; NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: No Information

  MAUDE report 8850030 ↗
• InjuryAug 1, 2019Fluid/Blood Leak; Fluid/Blood Leak

  RECEIVED A COPY OF THE CUSTOMER'S SUS VOLUNTARY EVENT REPORT FROM FDA WHICH STATES, ¿CARE FUSION EXTENSION SET REF # (B)(4) LEAKING BLOOD AT POINT BEHIND PT CONNECTION WHEN PRIMED TO THE END AFFECTED LOTS 19035714, 17116703, 17125852, 19025343". THERE WAS NO CUSTOMER/HOSPITAL NAME, ADDRESS, OR CONTACT PROVIDED; NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: No Information

  MAUDE report 8850028 ↗
• InjuryAug 1, 2019Fluid/Blood Leak; Fluid/Blood Leak

  RECEIVED A COPY OF THE CUSTOMER'S SUS VOLUNTARY EVENT REPORT FROM FDA WHICH STATES, ¿CARE FUSION EXTENSION SET REF # (B)(4) LEAKING BLOOD AT POINT BEHIND PT CONNECTION WHEN PRIMED TO THE END AFFECTED LOTS 19035714, 17116703, 17125852, 19025343". THERE WAS NO CUSTOMER/HOSPITAL NAME, ADDRESS, OR CONTACT PROVIDED; NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: No Information

  MAUDE report 8850003 ↗
• InjuryAug 1, 2019Fluid/Blood Leak; Fluid/Blood Leak

  RECEIVED A COPY OF THE CUSTOMER'S SUS VOLUNTARY EVENT REPORT FROM FDA WHICH STATES, ¿CARE FUSION EXTENSION SET REF # (B)(4) LEAKING BLOOD AT POINT BEHIND PT CONNECTION WHEN PRIMED TO THE END AFFECTED LOTS 19035714, 17116703, 17125852, 19025343." THERE WAS NO CUSTOMER/HOSPITAL NAME, ADDRESS, OR CONTACT PROVIDED; NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: No Information

  MAUDE report 8850001 ↗
• MalfunctionJul 25, 2019Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE USER WAS PRIMING THE EXTENSION TUBING ATTACHED TO 60 ML SYRINGE FOR A BLOOD TRANSFUSION WHEN THE USER NOTICED THAT THE TUBING LEAKED AT THE HUB WHEN THE CAP WAS IN PLACE. THE CUSTOMER STATED THAT "THE TUBING FAILURE SEEMS LIKE IT WAS IF THE AREA WAS NOT GLUED A SPACE NOTED BETWEEN THE DISTAL END TUBING AND SPIN COLLAR WHERE THE LEAK OCCURRED". IT WAS LATER REPORTED AND CONFIRMED BY THE RN THAT IT WAS A USER ISSUE AS THE CAP WAS LEFT IN PLACE DURING THE PRIME. WHEN PRIMING THE TUBING WITHOUT THE CAP THERE WAS NO LEAK NOTICED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT. THE EVENT OCCURRED IN THE NICU.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8825418 ↗