Alaris 10011301Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885403232541), received between Dec 7, 2018 and Apr 10, 2019 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (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.

• InjuryApr 10, 2019Obstruction of Flow; Difficult or Delayed Activation; Obstruction of Flow; Difficult or Delayed Activation

  IT WAS REPORTED THAT WHEN THE NURSE ATTEMPTED TO PRIME TWO PCEA SETS WITH NORMAL SALINE ON THE SAME PATIENT IN THE PACU, AN OCCLUSION WAS NOTED ON BOTH LINES. THE PATIENT DEVELOPED INCREASED PAIN AND REQUIRED AN UNSPECIFIED DOSE OF IV DILAUDID DUE TO THE OCCLUSIONS AND DELAY OF THERAPY. THE CLINICIAN OBTAINED A 3RD PCEA SET WHICH PRIMED WITHOUT DIFFICULTY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8499935 ↗
• InjuryApr 10, 2019Obstruction of Flow; Difficult or Delayed Activation; Obstruction of Flow; Difficult or Delayed Activation

  IT WAS REPORTED THAT WHEN THE NURSE ATTEMPTED TO PRIME TWO PCEA SETS WITH NORMAL SALINE ON THE SAME PATIENT IN THE PACU, AN OCCLUSION WAS NOTED ON BOTH LINES. THE PATIENT DEVELOPED INCREASED PAIN AND REQUIRED AN UNSPECIFIED DOSE OF IV DILAUDID DUE TO THE OCCLUSIONS AND DELAY OF THERAPY. THE CLINICIAN OBTAINED A 3RD PCEA SET WHICH PRIMED WITHOUT DIFFICULTY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8499574 ↗
• MalfunctionMar 7, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE EPIDURAL PCEA SET WAS ATTEMPTED TO BE PRIMED 6 TIMES WHILE IN THE PACU, HOWEVER EACH SET FAILED TO PRIME DUE TO AN OCCLUSION IN THE LINE. THE PAIN TEAM WAS NOTIFIED AND THE PATIENT WAS TRANSFERRED TO THE ICU TO DETERMINE IF THEIR EPIDURAL PCEA SETS WOULD PRIME. THERE WAS NO REPORT OF PATIENT HARM, AND THERE WAS NO DISTRESS OR INCREASE PAIN DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8402349 ↗
• MalfunctionMar 7, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE EPIDURAL PCEA SET WAS ATTEMPTED TO BE PRIMED 6 TIMES WHILE IN THE PACU, HOWEVER EACH SET FAILED TO PRIME DUE TO AN OCCLUSION IN THE LINE. THE PAIN TEAM WAS NOTIFIED AND THE PATIENT WAS TRANSFERRED TO THE ICU TO DETERMINE IF THEIR EPIDURAL PCEA SETS WOULD PRIME. THERE WAS NO REPORT OF PATIENT HARM, AND THERE WAS NO DISTRESS OR INCREASE PAIN DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8402336 ↗
• MalfunctionMar 7, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE EPIDURAL PCEA SET WAS ATTEMPTED TO BE PRIMED 6 TIMES WHILE IN THE PACU, HOWEVER EACH SET FAILED TO PRIME DUE TO AN OCCLUSION IN THE LINE. THE PAIN TEAM WAS NOTIFIED AND THE PATIENT WAS TRANSFERRED TO THE ICU TO DETERMINE IF THEIR EPIDURAL PCEA SETS WOULD PRIME. THERE WAS NO REPORT OF PATIENT HARM, AND THERE WAS NO DISTRESS OR INCREASE PAIN DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8402328 ↗
• MalfunctionMar 7, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE EPIDURAL PCEA SET WAS ATTEMPTED TO BE PRIMED 6 TIMES WHILE IN THE PACU, HOWEVER EACH SET FAILED TO PRIME DUE TO AN OCCLUSION IN THE LINE. THE PAIN TEAM WAS NOTIFIED AND THE PATIENT WAS TRANSFERRED TO THE ICU TO DETERMINE IF THEIR EPIDURAL PCEA SETS WOULD PRIME. THERE WAS NO REPORT OF PATIENT HARM, AND THERE WAS NO DISTRESS OR INCREASE PAIN DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8402288 ↗
• MalfunctionMar 7, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE EPIDURAL PCEA SET WAS ATTEMPTED TO BE PRIMED 6 TIMES WHILE IN THE PACU, HOWEVER EACH SET FAILED TO PRIME DUE TO AN OCCLUSION IN THE LINE. THE PAIN TEAM WAS NOTIFIED AND THE PATIENT WAS TRANSFERRED TO THE ICU TO DETERMINE IF THEIR EPIDURAL PCEA SETS WOULD PRIME. THERE WAS NO REPORT OF PATIENT HARM, AND THERE WAS NO DISTRESS OR INCREASE PAIN DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8402275 ↗
• MalfunctionDec 7, 2018Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT WHEN THE PATIENT WAS IN THE PACU, THE USER ATTEMPTED TO PRIME 6 EPIDURAL PCEA SETS HOWEVER EACH SET FAILED TO PRIME DUE TO OCCLUSION IN THE LINE. THERE WAS NO REPORT OF PATIENT HARM. THE PAIN TEAM WAS NOTIFIED AND THE PATIENT WAS TRANSFERRED TO THE ICU TO SEE IF THEIR EPIDURAL PCEA SETS WOULD PRIME. THE PATIENT WAS TRANSFERRED TO ICU AND WAS NOT IN ANY DISTRESS OR INCREASE PAIN DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8140803 ↗