ambIT 220501Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00857595005688), received between Sep 11, 2020 and Mar 30, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DEVICE WAS USED TO ADMINISTER ROPIVACAINE, AND INSTEAD OF SELECTING ML/HR, THE NURSE PROGRAMMED THE DEVICE TO RUN ML/MINUTE. THERE WERE NO INJURIES OR SYMPTOMS TO THE PATIENT. NURSE ADMITTED USER ERROR. ADDITIONAL INFORMATION RECEIVED (B)(6) 2021 INDICATED THE PUMP WAS INCORRECTLY PROGRAMMED BY NURSING STAFF MEMBER TO A RATE OF 10ML/5 MINUTES RATHER THAN 10ML/HOUR. THIS RESULTED IN THE PATIENT RECEIVING MORE THAN THE PRESCRIBED DOSAGE OF ROPIVACAINE. THE PATIENT EXPERIENCED NO ILL EFFECT AND REQUIRED NO MEDICAL INTERVENTION. THE PUMP ADMINISTERED THE PROGRAMMED INFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11590371 ↗
• InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD HEALTHY PATIENT EXPERIENCED SYMPTOMS OF REDNESS OF THE LEFT EYE, NAUSEA, SWEATING, AND FELT HOT, LIGHTHEADED, AND DIZZY, AFTER PLACEMENT OF AN AMBIT PIB-PCA FOLLOWING A PROCEDURE ON THE LEFT SHOULDER. THE PROCEDURE OCCURRED ON (B)(6) 2020 AND ENDED AT 11AM. ON AN UNKNOWN DATE POST PROCEDURE, THE PATIENT WENT TO PHYSICAL THERAPY AND BEGAN EXPERIENCING DIZZINESS, BUT FELT BETTER SOON AFTER. ON (B)(6) 2020, THE PATIENT EXPERIENCED THE DESCRIBED SYMPTOMS (REDNESS OF THE LEFT EYE, NAUSEA, SWEATING, AND FELT HOT, LIGHTHEADED, AND DIZZY). THE PATIENT'S MOTHER CALLED THE MANUFACTURER HOTLINE TO REPORT, AND WAS ADVISED TO CLAMP OFF THE CATHETER AND CALL THE ANESTHESIOLOGIST IMMEDIATELY. UPON FOLLOW UP, THE PATIENT'S MOTHER REPORTED THAT THE PATIENT WAS INSTRUCTED TO DISCONTINUE USE OF THE PUMP. FIVE MINUTES AFTER REMOVAL OF THE PUMP, THE PATIENT'S SYMPTOMS RESOLVED. NO ADDITIONAL INTERVENTION WAS REQUIRED. THE PHYSICIAN BELIEVES THE PATIENT'S SYMPTOMS WERE CAUSED BY THE MEDICATION LEAKING ONTO THE NERVE THAT INNERVATES THE EYE. NO FURTHER INFORMATION PROVIDED AT THIS TIME.

  Patient problems: Dizziness; Hot Flashes/Flushes; Nausea; No Code Available; Red Eye(s); Sweating

  MAUDE report 10608376 ↗
• InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FILL VOLUME: 500 ML. FLOW RATE: UNKNOWN. PROCEDURE: L SHOULDER REPLACEMENT. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT WAS HAVING A METALLIC TASTE IN HER MOUTH AND A LOSS OF BOWEL CONTROL ON (B)(6) 2020. THE PATIENT'S PHYSICIAN TOLD HER TO GO TO THE EMERGENCY ROOM (ER) FOR SYMPTOMS OF METALLIC TASTE AND DIZZINESS. THE PUMP WAS CLAMPED, AND THE PATIENT WAS ANXIOUS BUT FELT SYMPTOMS WERE BETTER SINCE CLAMPING THE PUMP. THE PATIENT'S DAUGHTER STATED THE PATIENT WAS DISCHARGED AND WAS DRIVING HOME WHICH WAS ABOUT AN HOUR AWAY. ADDITIONAL INFORMATION RECEIVED, 19-AUG-2020, FROM NURSE IN THE ER THE PATIENT HAD VISITED STATING: ER NURSE CALLING REGARDING PT [PATIENT] IN ER [HOSPITAL]. STATED PT [PATIENT] IN ER AND HAD SURGERY TODAY AND WAS TOLD TO GO TO ER FOR SYMPTOMS OF METAL TASTE AND DIZZINESS. PUMP CLAMPED AND STATED PT [PATIENT] ANXIOUS BUT FEELS SYMPTOMS ARE BETTER SINCE CLAMPING PUMP. ADDITIONAL INFORMATION RECEIVED 19-AUG-2020, AT 1833 MOUNTAIN STANDARD TIME (MST), STATING THE PUMP WAS REMOVED IN THE ER AND THE PATIENT WAS SENT HOME WITH ORAL PAIN MEDICATION THERAPY. ABOUT 30-MINUTES INTO THE DRIVE THE PATIENT SUDDENLY FELT DIZZY, FAINT, NAUSEAS, VOMITING FEELING, BOWEL INCO

  Patient problems: Anxiety; Dizziness; Fainting; Incontinence; Nausea; Vomiting

  MAUDE report 10521635 ↗