Kangaroo 385400Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10192253065701), received between Nov 21, 2024 and Jun 24, 2026 — classified as 1 death, 26 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Improper Flow or Infusion

  THE CUSTOMER REPORTED THAT THE CHILD HAD BEEN USING THE PUMP FOR A WHILE AND WHEN THE MOM REALIZED THE DEVICE WAS NOT INFUSING, HE WAS ADMITTED TO THE HOSPITAL. THE REASON THE CHILD WAS ADMITTED TO THE HOSPITAL AND THE MEDICAL INTERVENTION REQUIRED IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25608578 ↗
• InjuryMar 11, 2026Infusion or Flow Problem

  THE CUSTOMER REPORTED THE PATIENT ISN'T RECEIVING THE PRESCRIBED FLUSH VOLUME. THE PATIENT HAD HYPERNATREMIA DESPITE THE FLUSH RATE BEING INCREASED. THE PATIENT RECEIVED AN ADDITION OF D5W (5% DEXTROSE IN WATER) TO CORRECT THE HIGH SODIUM LEVELS AND INSULIN ADJUSTMENTS WERE MADE FOR INCREASED BLOOD GLUCOSE.

  Patient problems: Hypernatremia

  MAUDE report 24567776 ↗
• InjuryMar 11, 2026Infusion or Flow Problem

  THE CUSTOMER REPORTED THE PATIENT ISN'T RECEIVING THE PRESCRIBED FLUSH VOLUME. THE PATIENT HAD HYPERNATREMIA DESPITE THE FLUSH RATE BEING INCREASED. THE PATIENT RECEIVED AN ADDITION OF D5W (5% DEXTROSE IN WATER) TO CORRECT THE HIGH SODIUM LEVELS AND INSULIN ADJUSTMENTS WERE MADE FOR INCREASED BLOOD GLUCOSE.

  Patient problems: Hypernatremia

  MAUDE report 24567731 ↗
• InjuryMar 10, 2026Infusion or Flow Problem

  THE CUSTOMER REPORTED THE PATIENT ISN'T RECEIVING THE PRESCRIBED FLUSH VOLUME. THE PATIENT HAD HYPERNATREMIA DESPITE THE FLUSH RATE BEING INCREASED. THE PATIENT RECEIVED AN ADDITION OF D5W (5% DEXTROSE IN WATER) TO CORRECT THE HIGH SODIUM LEVELS AND INSULIN ADJUSTMENTS WERE MADE FOR INCREASED BLOOD GLUCOSE.

  Patient problems: Hypernatremia

  MAUDE report 24562481 ↗
• InjuryMar 5, 2026Infusion or Flow Problem

  THE CUSTOMER REPORTED A CONCERN WAS BROUGHT FORWARD DURING A NURSE PRACTICE COUNCIL. NURSING STAFF HAVE REPORTED, ALTHOUGH THE PUMP INDICATES THAT FLUSHES ARE BEING DELIVERED, THEY ARE NOT SEEING A CORRESPONDING DECREASE IN THE FLUSH BAG VOLUME. IF THE NURSE PROGRAMS THE PUMP FOR A FEED WITH A 200 ML FLUSH EVERY FOUR HOURS AT THE START OF THEIR SHIFT, THE FLUSH BAG IS FULL AT THE END OF THE SHIFT. THE FLUSH BAG VOLUME REMAINS UNCHANGED, EVEN THOUGH THE PUMP DISPLAYS THAT APPROXIMATELY 600 ML OF FLUSHES HAVE BEEN ADMINISTERED. THEY BELIEVE THE ISSUE RESULTED IN UNANTICIPATED ELECTROLYTE IMBALANCE. THERE WERE NO DISPLAY OR SOUND ALARMS DURING FEEDINGS. PATIENTS REQUIRED SODIUM CORRECTION. ADDITIONAL INFORMATION RECEIVED STATED THEY DO NOT HAVE ANY SPECIFICS BECAUSE THIS WAS DISCUSSED AT AN RN COUNCIL MEETING; HOWEVER, PATIENTS WERE REQUIRING IV INFUSIONS AND MANUAL WATER FLUSHES TO CORRECT THEIR SODIUM LEVELS.

  Patient problems: Electrolyte Imbalance

  MAUDE report 24521477 ↗
• InjuryFeb 11, 2026Intermittent Loss of Power

  THE CUSTOMER REPORTED THAT THE DEVICE HAS BEEN GLITCHING. IT IS NOT TURNING ON WHEN PLUGGED IN. ADDITIONAL INFORMATION WAS PROVIDED. THE ISSUE STARTED AFTER SOME TIME OF USE, BUT THE TIME WOULD VARY. IT WAS REPORTED TO BE STOPPING AROUND MID-FEED AND RIGHT AFTER THE PUMP WOULD START. THE DEVICE WOULD TURN ON BY ITSELF. IT WOULD DISPLAY ERROR CODES (AIR IN LINE, OCCLUSION ERROR, SYSTEM ERROR 10). THE PATIENT'S CARETAKER WOULD START THE PUMP, THE PUMP WOULD CONFIRM "STARTED", BUT FEEDING WOULD NOT OCCUR. THE DEVICE WAS MANUALLY TURNED OFF. PATIENT'S FAMILY REPORTED THAT IN THE PAST, THIS PUMP WOULD UNEXPECTEDLY POWER OFF ON ITS OWN, BUT NOT IN THIS SPECIFIC INCIDENT. NO HARM HAS BEEN REPORTED; HOWEVER, THE PATIENT WAS SENT TO THE HOSPITAL IN THE TIME PERIOD DUE TO VOMITING. FURTHER INFORMATION WAS PROVIDED STATING THAT THE ISSUE RESULTED IN INACCURATE FEEDINGS. UNFORTUNATELY, THE CAREGIVER DOES NOT HAVE SPECIFIC VOLUMES. NO ACTUAL AIR WAS FOUND IN THE LINE. THE PATIENT'S MOTHER SUSPECTS THE VOMITING IS LIKELY RELATED. THE PATIENT WAS HOSPITALIZED AND WAS STABILIZED. THE PATIENT IS CURRENTLY FEEDING ON ANOTHER UNIT (A KANGAROO JOEY PUMP) AND IS STABLE. THE PATIENT WAS NOT HARMED.

  Patient problems: Vomiting

  MAUDE report 24313222 ↗
• InjuryJan 14, 2026Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED ONE OF THEIR RESIDENT'S SON WAS WITH THE PATIENT IN THE ROOM AND OBSERVED THAT THE WATER LEVEL IN THE FLUSH BAG DID NOT APPEAR TO HAVE DECREASED AT ALL. HE MARKED THE LEVEL ON THE BAG AND NOTED THAT IT DID NOT DECREASE SIGNIFICANTLY OVER 48HRS. HE ALERTED STAFF AND WHEN THEY LOOKED AT THE PUMP HISTORY, IT APPEARED NO FLUSHES HAD OCCURRED OVER SEVERAL DAYS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS FOUND TO BE EXTREMELY DEHYDRATED. SHE RECEIVED IV FLUIDS AND WAS STARTED ON NOREPINEPHRINE. THE PATIENT WAS TRANSFERRED TO THE ICU AND A CENTRAL LINE WAS PLACED. THE PATIENT WAS EXTREMELY CONFUSED AND MOANING, BUT NOT TALKING. SHE HAD A DIARRHEAL BOWEL MOVEMENT AND ALSO VOMITED. THEY DISCOVERED THAT THE RESIDENT'S FEEDING PUMP DID NOT FLUSH AS PRESCRIBED/SET IN THE PUMP, AND THE PATIENT HAD NOT RECEIVED THE PROPER FLUSH AMOUNT FOR 10 DAYS. THE CUSTOMER TOOK THE PUMP AND CLEARED THE SETTINGS AND THE "CLEAR TOTAL VOLUMES" THEN RESET THE PUMP WITH THE FEEDING ORDERS AND THE SAME FEEDING SET THAT THE RESIDENT HAD BEEN USING. THE PUMP WAS SET TO FLUSH 50ML EVERY HOUR BUT NO FLUSHES OCCURRED DURING THE MORE THAN 3 HOURS IT WAS RUNNING.

  Patient problems: Dehydration

  MAUDE report 24070968 ↗
• InjuryDec 22, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED AN OMNI PUMP UNEXPECTEDLY PAUSED DURING USE. THE DEVICE SHOWED A CASSETTE ERROR. THIS RESULTED IN FEEDING INACCURACY, BUT THEY ARE UNABLE TO DETERMINE THE TOTAL AMOUNT NOT DELIVERED AS THE PUMP WAS FOUND OFF. THEY STATED THAT THEY ARE UNABLE TO CONFIRM IF THERE WERE ANY DISCREPANCIES IN THE FEEDING AMOUNT. THE PATIENT WAS FOUND HYPOGLYCEMIC DUE TO THE TUBE FEED ERROR. D50 WAS GIVEN TO THE PATIENT AND FEEDS WERE CHANGED TO BOLUS UNTIL A NEW PUMP WAS OBTAINED.

  Patient problems: Hypoglycemia

  MAUDE report 23863722 ↗
• InjuryDec 22, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED AN OMNI PUMP, THAT WAS PERFORMING A CONTINUOUS FEED, SPONTANEOUSLY SHUT OFF DURING USE. THE DEVICE SHOWED A CASSETTE ERROR. THIS RESULTED IN FEEDING INACCURACY, BUT THEY ARE UNABLE TO DETERMINE THE TOTAL AMOUNT NOT DELIVERED AS THE PUMP WAS FOUND OFF. THEY STATED THAT THEY ARE UNABLE TO CONFIRM IF THERE WERE ANY DISCREPANCIES IN THE FEEDING AMOUNT. THE PATIENT WAS FOUND HYPOGLYCEMIC DUE TO THE TUBE FEED ERROR. D50 WAS GIVEN TO THE PATIENT AND FEEDS WERE CHANGED TO BOLUS UNTIL A NEW PUMP WAS OBTAINED.

  Patient problems: Hypoglycemia

  MAUDE report 23863653 ↗
• InjuryNov 24, 2025Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED A SYSTEM ALARM 08 ON THE PUMP. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT AT 0800, THE RESIDENT'S ACCUCHECK WAS 6.2. THEY POURED THE SCHEDULED TUBE FEED AND ATTACHED TO THE RESIDENT'S GT PORT. SCHEDULED INSULIN GLARGINE 14 UNITS WAS ADMINISTERED TO THE RESIDENT. THE PUMP WAS TURNED ON AND STARTED. INITIALLY, THE SCREEN SHOWED "FLUSHING 75/150ML". THEY LEFT THE ROOM. AT 1105, THE ACCUCHECK WAS CHECKED AS SCHEDULED AND SHOWED 3.8. THEY CHECKED THE RESIDENT IN THE ROOM AND THE RESIDENT SHOWED NO OBJECTIVE AND SUBJECTIVE SYMPTOMS OF HYPOGLYCEMIA OTHER THAN THE BLOOD SUGAR. THEY CHECKED THE PUMP AND SAW THAT THE PUMP WAS STILL "FLUSHING 75/150ML". THEY ASSUMED THAT THE PUMPED NEVER FLUSHED THE LINE AND THE 0830 TUBE FEED NEVER RAN THROUGH AS THE BAG REMAINED FULL. THEY RE-PROGRAMMED THE PUMP TO INFUSE THE TUBE FEED. AT 1220, THE ACCUCHECK WAS RECHECKED AND SHOWED 3.5. HYPOGLYCEMIA PROTOCOL WAS FOLLOWED AND THEY ADMINISTERED 15GM OF GLUCOSE GEL VIA GT. THE INCIDENT WAS REPORTED OFF TO ANOTHER NURSE AS THE FIRST WENT FOR A BREAK. AFTER 15 MINUTES, THE NURSE RE-CHECKED THE ACCUCHECK OF THE RESIDENT AND IT SHOWED 3.0. THE NURSE ASSESSED THE TUBE FEED PUMP AND SIT

  Patient problems: Hypoglycemia

  MAUDE report 23631385 ↗
• InjuryNov 4, 2025Infusion or Flow Problem; Infusion or Flow Problem

  THE PATIENT'S GRANDSON REPORTED THE PUMP KEPT ALARMING "REMOVE CASSETTE" ERROR. ALL TROUBLESHOOTING WAS TRIED, INCLUDING REMOVING THE CASSETTE, USING A NEW BAG, CLEANING THE PUMP, AND RESTARTING. THE PROBLEM WAS NOT RESOLVED. THIS CAUSED DEHYDRATION, AND THE PATIENT WAS HOSPITALIZED DUE TO LACK OF FREE WATER BECAUSE THE PUMP WASN'T RUNNING. THE PATIENT NEEDED MULTIPLE BOLUSES TO MAKE UP FOR THE MISSED HYDRATION BECAUSE FOR ABOUT A WEEK HE WASN'T GETTING WATER.

  Patient problems: Dehydration

  MAUDE report 23464138 ↗
• InjuryOct 27, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED THE DEVICE IS UNDER DELIVERING. THE PATIENT'S BLOOD GLUCOSE FELL TO HYPOGLYCEMIC RANGE AGAIN, AT WHICH TIME THE MOM NOTICED THAT ALTHOUGH THE FEED PUMP INDICATED THE DRIP WAS INFUSING, THE VOLUME DELIVERED REMAINED UNCHANGED FOR WHAT WAS LIKELY 1-2 HOURS. IF THE FEEDING PUMP HAD BEEN INFUSING, THE PATIENT WOULD HAVE SUCCESSFULLY WEANED FROM THE IV. INSTEAD, THIS LED TO AN ADMISSION. ADDITIONAL INFORMATION: THIS PATIENT HAS A CONDITION CALLED GLYCOGEN STORAGE DISEASE TYPE 1A, IN THIS CONDITION PATIENTS REQUIRE A CONSTANT SOURCE OF CARBOHYDRATE TO PREVENT LIFE THREATENING HYPOGLYCEMIA. DURING THE STAY IN THE ED, THE PLAN WAS TO WEAN THE PATIENT OFF IV DEXTROSE BY HAVING CONTINUOUS NG TUBE FEEDS RUNNING. THE TUBE FEED PUMP INDICATED THE DRIP WAS INFUSING AT THE GOAL RATE; THEREFORE, THE IV DEXTROSE RATE WAS DECREASED TO A LOW RATE FOR DISCONTINUATION. BLOOD GLUCOSE FELL TO THE HYPOGLYCEMIC RANGE, THEREFORE THE IV WAS INCREASED BACK UP AND THE ED PLANNED TO ADMIT THE PATIENT TO THE UNIT IN VIEW OF BEING UNABLE TO WEAN THEM OFF THE IV DUE TO HYPOGLYCEMIA. WHEN THEY WERE TRANSFERRED, THE IV TUBE BROKE AND DEXTROSE WAS SPILLING ON THE FLOOR. THE FEEDING PUMP CONTINUE

  Patient problems: Hypoglycemia

  MAUDE report 23392184 ↗
• InjuryOct 15, 2025Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED THE PUMP WAS NOT WORKING. THIS WAS NOTICED AT 2030, AND THEY ARE NOT SURE IF THE PATIENT GOT HIS TUBE FEED SINCE THE MORNING, AS THE PATIENT IS SUPPOSED BE ON CONTINUES TUBE FEED. THE PATIENT'S TUBE FEED BAG WAS STILL FULL WHEN THIS WAS NOTICED AT 2030. THE PUMP WAS SHOWING THAT IT WAS FEEDING, BUT NOTHING WAS COMING OUT OF THE LINE. THE CHARGE NURSE WAS NOTIFIED. THIS ISSUE CAUSED THE PATIENT TO BECOME HYPOGLYCEMIC AS THE PATIENT HAD DECREASED LOC AND WAS FEELING DIZZY. TREATMENT WAS PROVIDED AS PROTOCOL AND THE MD WAS MADE AWARE. THE PATIENT HAS TYPE 2 DM AND WAS ADMITTED POST LIVER TRANSPLANT. THE PATIENT WAS ON CONTINUOUS NG TUBE FEEDS AND INSULIN EVERY 6 HOURS TO CONTROL HIS BLOOD SUGARS. IN THE EVENING, THE PATIENT'S BLOOD SUGAR WAS 1.8, AND HE HAD A NEAR-FALL (HIS BROTHER CAUGHT HIM). A STAT CHEST XR WAS ORDERED TO ENSURE THE TUBE WAS STILL IN PLACE. LATER THE STAFF DETERMINED THAT THE PATIENT'S PUMP WAS NOT WORKING, AND THE BAG THAT WAS HUNG EARLY IN THE DAY (~12H PRIOR) WAS COMPLETELY FULL. THE PATIENT'S BLOOD SUGAR WAS BETTER WHEN CHECKED LATER AND HE WAS ALERT AND ORIENTED. THE PUMP WAS REPLACED BY A NEW ONE, AND THE STAFF MADE SURE THAT HE WAS RECE

  Patient problems: Hypoglycemia

  MAUDE report 23290079 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A PATIENT HAS A PUMP ALARMING "CASSETTE FLIPPED" WHICH IS UNABLE TO BE CLEARED. THE PATIENT IS USING DUAL BAG FEATURE WITH KATE FARMS AT 80ML/HR. (B)(6) WENT TO THE HOME AND NEVER GOT AN ALARM DURING THE TIME THEY WERE THERE, BUT IT STILL ALARMED ALL NIGHT WITH ERRORS DEMONSTRATING "CASSETTES FLIPPED". THE PATIENT WAS HOSPITALIZED. ADDITIONAL INFORMATION RECEIVED STATED THE PATIENT WENT TO THE HOSPITAL WHILE WAITING FOR A REPLACEMENT PUMP BECAUSE THEY WERE UNABLE TO RUN THE PUMP TO FEED THEM AT HOME. CHANGING THE PUMP SET DID NOT SOLVE THE PROBLEM. THE CASSETTE APPEARED TO BE CORRECTLY CONNECTED WHEN THIS WAS HAPPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782319 ↗
• InjuryJul 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE DEVICE WAS INFUSING WATER INSTEAD OF TUBE FEEDING. THERE WAS A PATIENT EVENT OF LOW SODIUM DUE TO THE INACCURATE FREE WATER ADMINISTERED. ADDITIONAL INFORMATION RECEIVED ON 11JUL2025 STATED THAT THE SERIAL NUMBER OF THE PUMP USED IS UNKNOWN. THE PRODUCT NUMBER AND LOT NUMBER OF THE FEEDING SET IS UNKNOWN. FEED RATE/VOLUME SETTINGS ARE UNKNOWN. FLUSH RATE/VOLUME SETTINGS ARE UNKNOWN. AMOUNT OF FEED DELIVERED IS UNKNOWN. AMOUNT OF FLUSH DELIVERED IS UNKNOWN. IT IS NOT KNOWN IF THE PUMP HISTORY LOGGED THIS AS FEED OR FLUSH. THE PATIENT WAS TRANSFERRED FROM A MEDICAL SURGICAL UNIT (LOWER LEVEL OF CARE) TO THE INTENSIVE CARE UNIT (HIGHER LEVEL OF CARE). ONCE IN THE INTENSIVE CARE UNIT THE PATIENT RECEIVED HYPERTONIC SALINE (3% SALINE) TO CORRECT SODIUM LEVELS AND RECEIVED SEIZURE PRECAUTION MONITORING. THE PATIENT WAS DISCHARGED AND IS ALIVE.

  Patient problems: Hyponatremia

  MAUDE report 22563958 ↗
• DeathJun 5, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE VP OF NURSING REACHED OUT TO A CARDINAL HEALTH SALES REP TO INFORM THAT A PATIENT WHO HAD BEEN ON A KANGAROO OMNI PUMP DID NOT APPEAR TO BE RECEIVING THE CORRECT FLUSHING VOLUMES. THE PATIENT WAS STARTED ON (B)(6) 2025 FOR GLUCERNA ENTERAL FEEDINGS. THE ORDERS FOR PUMP DELIVERY WERE TO FEED 40ML/HR AND FLUSH 200ML EVERY 6H. THE DAUGHTER SAID THE PUMP WAS NOT FLUSHING AND THE PATIENT BECAME DEHYDRATED. THE DAUGHTER SAID WHEN SHE WOULD CHANGE THE BAG EVERY DAY SHE SAW THAT THE WATER WAS STILL IN THE BAG BUT DIDN'T CALL TO ASK WHY. THE PATIENT WAS ADMITTED TO ICU ON (B)(6) 2025 FOR DEHYDRATION. AND PASSED AWAY ON (B)(6) 2025. ADDITIONAL INFORMATION RECEIVED: THE PATIENT WAS ADMITTED (B)(6) 2025, FOR ENTERAL THERAPY WITH DYSPHAGIA RELATED TO CVA AND IV ANTIBIOTIC THERAPY FOR POSITIVE BLOOD CULTURES. MEDICAL HISTORY DOCUMENTED AT THAT TIME INCLUDED HYPERLIPIDEMIA, HYPERCHOLESTEROLEMIA, TYPE II DIABETES MELLITUS, OSTEOPOROSIS, DEGENERATIVE LUMBAR SPINE DISEASE, AND SUSPECTED DEMENTIA.

  Patient problems: Dehydration

  MAUDE report 22152095 ↗
• InjuryMay 6, 2025Improper Flow or Infusion; Improper Flow or Infusion

  THE CRITICAL CARE DIRECTOR REPORTED THE BEDSIDE NURSES ARE REPORTING THE OMNI PUMPS ARE FREQUENTLY STOPPING MID FEEDING AND ALARMING. THEY SAID SOMETIMES IT IS OCCURRING EVERY 5 MINUTES. SOMETIMES IT CORRECTS WITH REPRIMING THE TUBING. OTHER TIMES THEY REPRIME MULTIPLE TIMES AND THEN GET A NEW FEEDING SET. THE MED SURG NURSES TODAY HEARD OF SIMILAR ISSUES WITH THE PUMP BEEPING AND STOPPING MID FEEDING. ONE PATIENT WHO HAD A PEG HAD TO HAVE THE PEG FLUSHED OUT EACH TIME THE PUMP PAUSED. A REPORT FROM A REGISTERED DIETICIAN THAT A PATIENT WHO HAD SCHEDULED WATER FLUSHES HAD A HIGH SODIUM THE NEXT DAY, AND PUMP STOPPAGE ISSUES WERE SUSPECTED. ADDITIONAL INFORMATION RECEIVED STATED THE CONCERNS WERE BROUGHT UP IN A HUDDLE GROUP MEETING AFTER THE EVENTS BY THE BEDSIDE NURSES AND DIETICIAN IN THE UNIT. THE PATIENT WITH THE HIGH SODIUM WAS TRANSFERRED TO THE ICU FOR HYPERNATREMIA (HIGH SODIUM IN THE BLOOD) FROM A MED SURGICAL UNIT. THE PATIENT HAD CARDIAC MONITORING, FREE WATER FLUSHES, AND FREQUENT LABS.

  Patient problems: Hypernatremia

  MAUDE report 21968487 ↗
• InjuryApr 30, 2025Improper Flow or Infusion; Improper Flow or Infusion

  THE CUSTOMER REPORTED THE PUMP IS NOT GIVING THE PROGRAMMED FLUSH DURING TUBE FEEDING. THIS HAS CONTRIBUTED TO WORSENING RENAL FUNCTION. THE PATIENT WAS STARTED ON IV FLUIDS WHEN IV ACCESS BECAME AVAILABLE, AS THE PATIENT HAD DIFFICULT VASCULATURE.

  Patient problems: Dehydration

  MAUDE report 21938226 ↗
• InjuryApr 29, 2025Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED THE RN, WHO HAD THE PATIENT UNTIL 1900, REPORTED THAT SHE CHANGED THE TUBING IN THE EVENING AND THAT THE PUMP WAS RUNNING FINE. SHE APPROPRIATELY CHARTED ON THE LDA FOR HER 1600 CHARTING AS WELL. SHE CHANGED THE PUMP SHORTLY BEFORE SHIFT SWITCH. WHEN THE NIGHT TEAM CAME INTO THE ROOM AT 2000, THEY NOTED THAT THE PUMP WAS OFF. THEY TURNED THE PUMP BACK ON, CHECKED THE PATIENT'S SUGAR, AND FOUND IT TO BE IN THE 30S. THEY GAVE HER DEXTROSE, AND THE PATIENT RECOVERED WITHOUT ANY SYMPTOMS OR ISSUES. THEY ASKED THE STAFF WHO WERE IN THE ROOM FROM 1900-2000, AND THEY DON¿T RECALL SEEING THE PUMP OFF OR ON, THEY WEREN¿T REALLY CHECKING. THEY CHECKED THE PUMP AND SAW THAT IT HAD RUN 100 CC SINCE THE RN FROM DAY SHIFT CHANGED THE TUBING, MEANING HER STORY TRACKS. WHEN SHE CHANGED THE TUBING, IT WAS RUNNING FINE. CONTRIBUTING FACTORS: PATIENT HAS HAD DISPROPORTIONATE NUMBER OF HYPOGLYCEMIC EVENTS DURING HER ADMISSION. THE STAFF HAVE SUSPICIONS OF THIS PATIENT PERHAPS SABOTAGING HER OWN FEEDS IN THE PAST, BUT THEY DON'T THINK THE PATIENT DID THIS TIME.

  Patient problems: Hypoglycemia

  MAUDE report 21925415 ↗
• InjuryApr 3, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED THE STAFF DID NOT NOTICE THAT THE PUMP WAS UNDER FLUSHING FOR DAYS RESULTING IN THE RESIDENT BEING HOSPITALIZED FOR DEHYDRATION. THE RESIDENT GETS WEEKLY LABS DRAWN; THIS WAS HOW IT WAS DISCOVERED THAT THE PATIENT WAS DEHYDRATED. THE PUMP WAS SET ON CONTINUOUS MODE WITH FEED SET AT 75ML/HR AND FLUSH AT 40ML AT 1 HOUR INTERVAL. THE CUSTOMER RAN A MANUAL TEST USING A BSPFF SET AND THE PUMP PASSED. THEY RAN THE PUMP AT THE CURRENT SETTINGS. FLUSH SHOWED 0 MIN TO NEXT FLUSH, 40 ML EVERY 1 HOURS, TOTAL FLUSHED: 1531 ML. THEY TRIED RUNNING FLUSH NOW, AND INITIALLY GOT A FLUSH ERROR AND OBSERVED AIR IN THE FLUSH TUBE. THEY RAN A MANUAL PRIME FOR FLUSH AND THEN WAS ABLE TO COMPLETE FLUSH NOW. THE CUSTOMER CHECKED THE FEEDING HISTORY. "CLEAR VOLUMES" SHOWED FED: 14955, FLUSH 1530. THEY DID NOT KNOW WHEN IT WAS LAST CLEARED. ADDITIONAL INFORMATION RECEIVED STATED THE PATIENT NEEDED 2 ONE LITER IV'S FOR FLUIDS AND THEN WAS SENT TO THE HOSPITAL.

  Patient problems: Dehydration

  MAUDE report 21761534 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE PATIENT HAS A SERIOUS FATTY ACID OXIDATION DISORDER REQUIRING A MINIMUM AMOUNT OF CALORIES TO PREVENT OR TREAT SEVERE RHABDOMYOLYSIS. SHE REQUIRES CONTINUOUS NOCTURNAL FEEDING TO PREVENT CATABOLISM AND SUBSEQUENT SYMPTOMS OF RHABDO. WHEN ILL OR DURING TIMES OF RHABDO, SHE REQUIRED CONTINUOUS FEEDS TO TREAT OR PREVENT EXACERBATION OF RHABDO. ON THE NIGHT ON (B)(6) 2025 HER NOCTURNAL FEEDS WERE SET AND STARTED ON THE PUMP AS USUAL. IN THE MORNING IT WAS DISCOVERED THAT THE FEEDS DID NOT RUN THROUGH THE PUMP AND THE FEED BAG WAS STILL FULL. AS A RESULT, THE PATIENT HAD SIGNIFICANT SYMPTOMS OF RHABDO. THIS IS A NEW OMNI PUMP THAT WAS SWITCHED ON (B)(6) 2024 FOR ANOTHER OMNI PUMP FOR SIMILAR REASONS. IF THE PATIENT HAS RHABDO AND REQUIRES CONTINUOUS FEEDS THROUGHOUT THE DAY, HER PUMP USUALLY RUNS DURING THE SCHOOL DAY SO SHE DOESN'T MISS SCHOOL. SINCE THE PUMP WAS SWITCHED ON (B)(6) 2024, SHE HAS MISSED ~5 DAYS OF SCHOOL BECAUSE THE PUMP CONTINUES TO ALARM ALL DAY AND DISTURBS THE CLASS. THEREFORE, SHE HAS BEEN MISSING SCHOOL SO SHE CAN HAVE HER CONTINUOUS FEEDS DURING THE DAY WITHOUT DISTURBING OTHERS.

  Patient problems: Unspecified Gastrointestinal Problem

  MAUDE report 21730241 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THEY TRIED TO USE THE PUMP AND AFTER ABOUT 5 MINUTES THEY STARTED TO SHOW SIGNS OF HAVING A SEIZURE AND HAD TO STOP. THE FREQUENCY AND VOLUME OF THE MECHANISM THAT DOES THE PUMPING IN THE OMNI PUMP IS SETTING OFF AN EPILEPTIC SEIZURE. ADDITIONAL INFORMATION: IT WAS CLARIFIED THAT THE END USER HAS AN EPILEPTIC DISORDER, APM1, WHICH MAKES HER VERY SENSITIVE TO SOUNDS. THE OMNI DID NOT CAUSE HER TO HAVE A SEIZURE. THE GRINDING OF THE OMNI MADE HER EXHIBIT PRE-SEIZURE SYMPTOMS, DESPITE THE OMNI PUMP ONLY BEING AT 37 DB VS 47 DB ON THE JOEY PUMP THE FAMILY HAS DECIDED TO REMAIN ON THE JOEY PUMP.

  Patient problems: Epilepsy

  MAUDE report 21503934 ↗
• InjuryFeb 18, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED A PATIENT WAS RECEIVING A BOLUS FEED VIA HIS OMNI FEEDING PUMP THROUGH HIS G-TUBE. THE PUMP KEPT ALARMING THAT IT WAS CLOGGED. THE PATIENT'S PARENTS WERE ABLE TO BY-PASS THE ALARM, AND THE PUMP REPORTED THAT IT HAD DELIVERED HIS FULL 90ML FEED. HOWEVER, IT DID NOT. AS A RESULT, THE PATIENT'S BLOOD SUGARS DROPPED TO 3.2MMOL/L QUICKLY. THE PATIENT HAS A DEXCOM CONTINUOUS GLUCOSE MONITOR BECAUSE OF A METABOLIC CONDITION (GLYCOGEN STORAGE DISEASE TYPE 1B) WHERE HE IS NOT ABLE TO FAST WITHOUT RECEIVING EXOGENOUS GLUCOSE TO MAINTAIN HIS BLOOD SUGARS. THE MONITOR ALERTED THE PARENTS OF THE DROPPING BLOOD SUGAR.

  Patient problems: Hypoglycemia

  MAUDE report 21405263 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THE PATIENT HAS A SEVERE FATTY ACID OXIDATION DISORDER REQUIRING A SEVERELY FAT RESTRICTED DIET SUPPLEMENTED WITH MCT BASED FORMULA. FAILURE TO INTAKE ADEQUATE CALORIES CAN RESULT IN SIGNIFICANTLY ELEVATED CREATININE KINASE LEVEL FROM RHABDOMYOLYSIS WHICH CAN CAUSE ORGAN DAMAGE AND COULD POTENTIALLY BE FATAL. THE PATIENT IS ON CONTINUOUS NOCTURNAL G-TUBE FEEDS AND OCCASIONALLY, IN TIMES OF ILLNESS, THROUGHOUT THE DAY AS WELL. THE FEED PUMP WAS SWITCHED (B)(6) 2024, TO THE OMNI M761099. SINCE THEN, THE PUMP HAS BEEN CLOGGING AND BEEPING OFTEN. THIS HAS CAUSED THE PATIENT TO MISS ESSENTIAL CALORIES FROM THE FORMULA FEEDS AT NIGHT, AND SHE HAS BEEN REFUSING TO USE IT DURING THE DAY WHEN SHE REQUIRES IT. ON THE NOTED DATE, SHE WAS SHOWING SYMPTOMS OF RHABDOMYOLYSIS, SO A HIGHER CALORIE FORMULA RECIPE WAS REQUIRED OVERNIGHT. THE PUMP CLOGGED AND MALFUNCTIONED MANY TIMES THROUGHOUT THE NIGHT CAUSING THE PATIENT TO NOT RECEIVE THE REQUIRED CALORIES AND THE PATIENT CONTINUED RHABDOMYOLYSIS SYMPTOMS INTO THE FOLLOWING DAY. THE FORMULA CONCENTRATION IS ~1 KCAL/ML. THE MCT IN THE FORMULA IS LIKELY CAUSING THE PROBLEM WITH THE PUMP.

  Patient problems: Unspecified Gastrointestinal Problem

  MAUDE report 21401966 ↗
• InjuryJan 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  (B)(6) 2025, ADDITIONAL INFORMATION: WE RECEIVED AN UPDATE FROM THE CUSTOMER'S BIOMED THAT THE PATIENT WAS NOT METABOLIC, AND THE PATIENT WAS NOT HARMED BY THE INCIDENT ACCORDING TO THE INFORMATION SHE RECEIVED.

  Patient problems: Discomfort

  MAUDE report 21282411 ↗