AVANOS 13568Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00193494135683), received between Jun 19, 2020 and Jan 19, 2026 — classified as 3 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (18 reports).

3 other recalls cover devices cleared under the same FDA submission (K052117); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2026Improper Flow or Infusion

  FILL VOLUME: 230 ML NACL FLOW RATE: 5ML/HR OVER 46 HOURS DRUG: FLUOROURACIL (5-FU) 4950 MG PROCEDURE: UNKNOWN CATHPLACE: UNKNOWN INFUSION START TIME: UNKNOWN INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED; THE INFUSION RAN 6 HOURS SHORTER THAN WHAT IT SHOULD HAVE. PER ADDITIONAL INFORMATION RECEIVED ON 5JAN2026, THE PUMP IS KEPT IN A FANNY PACK DESIGNED FOR HOME INFUSION PUMPS. THE PUMP WAS KEPT BELOW THE INFUSION SITE.

  Patient problems: Insufficient Information

  MAUDE report 24109487 ↗
• MalfunctionJul 10, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 230ML, FLOW RATE: UNKNOWN, PROCEDURE: CHEMOTHERAPY, CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT WAS PUT ON A HOMEPUMP INFUSER TO TAKE HIS CHEMOTHERAPY TREATMENT AT HOME AND THE DRUG INFUSION WAS FINISHED "11-HOURS BEFORE THE ESTIMATED TIME. THE PATIENT CAME DUE TO EARLY WITHDRAWAL OF THE DEVICE AND ALSO MENTIONED THAT SOMETIMES THEY RUN OUT IN THE MIDDLE OF THE NIGHT.¿ ADDITIONAL INFORMATION RECEIVED 18-JUN-2025 STATING "THE PATIENT TRIED TO INFUSE 230ML OF 5-FLUOROURACIL IN 46-HOURS AT HOME AND THEY MENTION THAT THE INFUSION WAS COMPLETED IN 10 HOURS LESS, SO THE APPROXIMATE ACTUAL INFUSION TIME WAS 36 HOURS." ADDITIONAL INFORMATION RECEIVED 18-JUN-2025 STATING THE FLOW RESTRICTOR WAS PLACED AND TAPED TO THE PATIENT ACCORDING TO NORMAL PROCEDURE. THERE WASN'T ANY TAPE OVER THE AIR FILTER. THE PATIENT DID NOT APPLY ANY ADDITIONAL PRESSURE TO THE PUMP (SUCH AS LAYING ON IT WHILE SLEEPING, ETC.).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469053 ↗
• MalfunctionMay 15, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2025-00012 FOR THE SECOND EVENT. FILL VOLUME: 270LM. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED "THE INFUSION WAS FINISHED NINE HOURS AHEAD OF SCHEDULE.¿ THE USERS INTENDED TO INFUSE 270ML IN 54-HOURS. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22032020 ↗
• MalfunctionMay 15, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. FILL VOLUME: 270LM, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED "THE INFUSION WAS FINISHED NINE HOURS AHEAD OF SCHEDULE.¿ THE USERS INTENDED TO INFUSE 270ML IN 54-HOURS. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22032019 ↗
• MalfunctionApr 22, 2025Improper Flow or Infusion; Improper Flow or Infusion

  FILL VOLUME: 241 ML, FLOW RATE: 5 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: ON (B)(6) 2025 1400, INFUSION STOP TIME: ON (B)(6) 2025 4PM. IT WAS REPORTED, ¿A PATIENT'S 5FU ELASTOMERIC PUMP WAS ATTACHED ON (B)(6) 2025 SHORTLY AFTER 2 PM. THE ORDERED DOSE WAS 2800MG/241ML NS TO INFUSE OVER 46 HRS WAS PREPARED BY HH PHARMACY ON (B)(6) 2025. THE PATIENT REPORTED THAT AT 4PM ON (B)(6) 2025, THE PUMP WAS EMPTY AND SHE FELT INTOXICATED. SHE WAS GIVEN THE PHONE NUMBER TO THE HH PHARMACY PRIOR TO DISCHARGE ON (B)(6) 2025 AND INSTRUCTED TO CALL WITH ANY PUMP ISSUES OVER THE WEEKEND. SHE DID NOT CALL THE HH PHARMACY. SHE CALLED THE CLINIC ON (B)(6) 2025 MORNING AND WAS INSTRUCTED TO GO TO THE ER. SHE DID NOT GO TO THE ER. SHE RETURNED TO THE CLINIC ON MONDAY MORNING, ON (B)(6) 2025, AND THE PUMP WAS DISCONNECTED. THE PUMP WAS CONFIRMED TO BE THE CORRECT PUMP (5ML/HR OVER 46 HOURS). THE SENSOR WAS STILL TAPED TO HER SKIN AND SHE STATES SHE HAD NO MAJOR CHANGES IN BODY TEMPERATURE. RESPONSE FROM HOME HEALTH: THE COMPOUNDING RECORD OF THE RX IN QUESTION WAS REVIEWED, AND THE QUANTITY (VOLUME) OF NS AND FLUOROURACIL NEEDED FOR THE COMPOUNDING OF THE RX WAS CORRECT. THE TE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21882292 ↗
• MalfunctionJan 6, 2025Improper Flow or Infusion; Improper Flow or Infusion

  FILL VOLUME: 241 ML . FLOW RATE: 5 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN . INFUSION START TIME: (B)(6) 2024 AT 1340. INFUSION STOP TIME: (B)(6) 2024 AT 1522. IT WAS REPORTED, ¿PATIENT REPORTED HE BELIEVED AN AVANOS C270050 LOT 20119996 EXP 09/24/2026 PUMP WAS RUNNING TOO FAST DUE TO WRINKLING AND WEIGHT OF THE BAG. IT WAS HIS 49TH CYCLE SO HE IS FAMILIAR WITH THE PRODUCT.¿ IT WAS ADDITIONALLY REPORTED ¿PATIENT CALLED (B)(6) 2024 15:22 REPORTING HE BELIEVED PUMP WAS RUNNING FASTER THAN IT SHOULD. HE REPORTED IT WAS MORE WRINKLED AND LIGHTER THAN USUAL. PATIENT IS ON HIS 49TH CYCLE SO HE IS FAMILIAR WITH THE DRUG. VISUALLY WRITER (RPH) AND INFUSION NURSES COULD NOT TELL. PHONE CALL DOCUMENTATION ¿CALL TRANSFERRED TO WRITER BY CARE ACCESS - PATIENT LEFT DNG MED ON CLINIC WITH 5FU PUMP - HE REPORTS THAT PUMP APPEARS TO BE EMPTYING QUICKER THAN PREVIOUS CYCLES. INNER BULB OF 5FU PUMP IS STILL FIRM PER PATIENT BUT BULB HAS SEEMED TO ALREADY DECREASE IN SIZE NOTED BY OUTER LAYER OF PUMP. PATIENT DENIES ANY NEW/ADVERSE SYMPTOMS AT THIS TIME. INSTRUCTED PATIENT TO CLAMP 5FU PUMP - AND WILL PROCEED TO DNG CLINIC FOR RN ASSESSMENT OF PUMP. PATIENT VERBALIZED UNDERSTANDING - SCHEDULE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085157 ↗
• MalfunctionOct 24, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2024-00058 FOR THE SECOND EVENT. FILL VOLUME: 241 ML FLOW RATE: 5 ML/HR PROCEDURE: UNKNOWN CATHPLACE: UNKNOWN IT WAS REPORTED, THE ELASTOMERIC PUMP HAD "COMPLETED TOO QUICKLY." THERE WAS NO REPORTED INJURY. "THE PUMP SHOULD INFUSE AT 5 ML/HR OVER 42-HOURS. HOWEVER, WHEN THE PATIENT RECENTLY RETURNED TO CLINIC, THE PATIENT STATED THAT THE PUMP EMPTIED ITS CONTENTS OVER APPROXIMATELY 35-HOURS. THE PATIENT REPORTED THAT SHE SLEEPS WITH THE INFUSER BALL BENEATH HER BEDSHEETS WHEN SLEEPING." THE "PATIENT HAD THE HOMEPUMP PLACED CORRECTLY IN RELATION TO THE PORT'S LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523859 ↗
• MalfunctionOct 24, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2024-00057 FOR THE FIRST EVENT. FILL VOLUME: 241 ML. FLOW RATE: 5 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED, THE ELASTOMERIC PUMP HAD "COMPLETED TOO QUICKLY." THERE WAS NO REPORTED INJURY. "THE PUMP SHOULD INFUSE AT 5 ML/HR OVER 46-HOURS. THE PATIENT REPORTED THAT THE INFUSION FINISHED AT APPROXIMATELY 39-HOURS. THE PATIENT REPORTED THAT SHE SLEEPS WITH THE INFUSER UNDER THE SHEETS AT NIGHT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523840 ↗
• MalfunctionJun 6, 2024Improper Flow or Infusion; Improper Flow or Infusion

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: (B)(6) 2024. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, PATIENT REPORTS A FAST FLOW WITH HOMEPUMP C SERIES. PUMP WAS COVERED WITH A BLANKET DURING TREATMENT BUT THE PUMP WAS PLACED ON TOP OF THE COVER, FLOW RESTRICTOR WAS NOT TAPED TO THE PATIENT'S BODY; APPROXIMATELY 5 HOURS LEFT OF TREATMENT WHEN PUMP WAS EMPTY. PATIENT REPOTS NO INJURY OCCURRED. TREATMENT WAS DONE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19478251 ↗
• MalfunctionMay 30, 2024Improper Flow or Infusion; Improper Flow or Infusion

  FILL VOLUME: 241 ML. FLOW RATE: 5ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN.. INFUSION STOP TIME: UNKNOWN IT WAS REPORTED, PUMP INFUSED MUCH FASTER THAN THE INTENDED 46 HOURS, AS EARLY AS 1 DAY. THE EVENT OCCURRED TWO YEAR AGO. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19425069 ↗
• MalfunctionApr 9, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 241 ML. ADDITIONAL INFORMATION RECEIVED STATED THE AMBIENT TEMPERATURE FOR THE ENVIRONMENT THE PUMP WAS BEING USED IN WAS AN AVERAGE OF 29°C. THE TUBING OF THE DEVICE WAS ABOVE THE PATIENT'S CLOTHES AND/OR BLANKET, THE FLOW RESTRICTOR WAS GLUED TO THE PATIENT'S SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19071601 ↗
• MalfunctionMar 12, 2024

  PATIENT RECEIVED CHEMOTHERAPY TREATMENT, WHICH INCLUDED A 5FU (FLUOROURACIL) HOMEPUMP TO BE ATTACHED AND INFUSE OVER 46 HOURS. PATIENT WAS TREATED WITHOUT INCIDENCE AND DISCHARGED HOME WITH HIS 5FU HOMEPUMP ATTACHED AND INFUSING. NO REPORT FROM PATIENT OVER THE SUBSEQUENT 46 HOURS UNTIL PATIENT REPORTED TO THE CLINIC, WHERE HE TYPICALLY GETS HIS PUMP DISCONNECTED ON DAY #3 OF CYCLE. IT WAS DISCOVERED THAT THE PUMP DID NOT COMPLETELY INFUSE. ONCOLOGY REGISTERED NURSE (RN) WAS CONTACTED, AND PATIENT WAS INSTRUCTED TO GO TO THE CANCER CENTER FOR FURTHER INSTRUCTIONS. RN NOTIFIED ONCOLOGY PROVIDER AND IT WAS DECIDED TO MAKE A 24 HOUR INFUSION HOMEPUMP WITH 50% OF DOSE. WHEN PATIENT ARRIVED, CURRENT HOMEPUMP WAS INSPECTED, AND IT WAS DETERMINED PATIENT RECEIVED APPROXIMATELY 50% OF MEDICATION IN THE 46 HOUR PERIOD. NEW PUMP WAS ATTACHED, AND PATIENT WAS DISCHARGED TO HOME. PATIENT IS SCHEDULED TO REPORT BACK AFTER 24 HOURS FOR PUMP DISCONNECT AND CALL IF ANY QUESTIONS OR CONCERNS ARISE. LOT: 30258409. EXP. 11/30/2025. HOMEPUMP C-SERIES 270 ML - 5 ML/HR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886072 ↗
• MalfunctionFeb 13, 2024Improper Flow or Infusion; Improper Flow or Infusion

  FILL VOLUME: 225 ML. FLOW RATE: 5 ML/HR. PROCEDURE: UNKNOWN . CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN 14:40. INFUSION STOP TIME: UNKNOWN 05:00. IT WAS REPORTED VIA FDA VOLUNTARY MEDWATCH REPORT MW5149669, "5-FLUOROURACIL (5-FU) COMPOUNDED BY (B)(6) ON (B)(6) 2023. 4000 MG IN 225 ML IN AN AMBULATORY "BALLOON PUMP" (AVANOS HOMEPUMP C-SERIES ELASTOMERIC PUMP, LOT#30200981, EXP: 1/2/2025). THESE PUMPS ARE MADE AND SETUP TO ADMINISTER THE 225 ML OVER 46 (FORTY-SIX) HOURS. PATIENT HOOKED UP TO PUMP ON (B)(6) 2023 AT14:40. EXPECTED THE PUMP TO RUN OUT AROUND (B)(6) 2023 AT 12:40. PATIENT REPORTED THAT PUMP RAN EMPTY (B)(6) 2023 AT "05:00, 7 HOURS EARLY. PHARMACY VERIFIED VIA IVX SOFTWARE (PHOTOGRAPHS OF PREPARATION) THAT CORRECT VOLUME WAS ADDED TO PUMP PRIOR TO DISPENSING. PATIENT DENIED ANY LEAKING FROM PUMP. NURSING STAFF DENIED ANY ISSUES WITH PUMP. PUMP WAS INSPECTED FOR DEFECTS - NONE FOUND. PATIENT WAS EDUCATED ON POSSIBLE SIDE EFFECTS TO FASTER-THAN-PLANNED INFUSION - VETERAN DENIED ANY SIDE EFFECTS. PATIENT INSTRUCTED TO CALL PROVIDER IF SAID SIDE EFFECTS DEVELOP. PHARMACY HAS SEQUESTERED THE 2 REMAINING AVANOS HOMEPUMP C-SERIES ELASTOMERIC PUMPS WITH LOT#30200981, EXP:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699630 ↗
• MalfunctionJan 12, 2024Improper Flow or Infusion; Improper Flow or Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2024-00005 FOR THE FIRST REPORT. REFER TO 2026095-2024-00007 FOR THE THIRD REPORT. THE PUMP WAS SCHEDULED FOR INFUSION OVER THREE DAYS BUT WAS FINISHED AHEAD OF TIME. FURTHER DETAILS FOR REPORTING WERE NOT OBTAINED. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18507446 ↗
• MalfunctionJan 12, 2024Improper Flow or Infusion; Improper Flow or Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2024-00006 FOR THE SECOND REPORT. REFER TO 2026095-2024-00007 FOR THE THIRD REPORT. FILL VOLUME: 243 ML. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN . INFUSION START TIME: (B)(6) 2024 4:20 PM. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, PATIENT WITH ARTHROSCOPIC KNEE LIGAMENT RECONSTRUCTION SURGERY, HAD A PUMP INSTALLED ON (B)(6) 2023 AT 4:20 PM FOR PAIN CONTROL. THE PUMP WAS INTENDED TO INFUSE FOR FIVE DAYS. ON DAY FOUR OF TREATMENT, AT 10:10 PM, THE PUMP HAD VERY LITTLE VOLUME. THERE WAS STILL APPROXIMATELY 18 HOURS LEFT FOR THE INFUSION. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18507335 ↗
• MalfunctionJan 12, 2024Improper Flow or Infusion; Improper Flow or Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2024-00005 FOR THE FIRST REPORT. REFER TO 2026095-2024-00006 FOR THE SECOND REPORT. THE PUMP WAS SCHEDULED FOR INFUSION OVER THREE DAYS BUT WAS FINISHED AHEAD OF TIME. FURTHER DETAILS FOR REPORTING WERE NOT OBTAINED. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18507332 ↗
• MalfunctionAug 7, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED VIA FDA MEDWATCH MW5119232 THE FOLLOWING INFORMATION: INCORRECT ECLIPSE PUMP USED TO INFUSE PATIENT; 5FU INFUSED OVER APPROXIMATELY 24HRS, AS OPPOSED TO THE PRESCRIBED 96HRS.

  Patient problems: Insufficient Information

  MAUDE report 17477215 ↗
• MalfunctionJul 11, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED SEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING SEVEN DIFFERENT EVENTS. THIS IS THE FIRST OF SEVEN REPORTS. REFER TO 2026095-2023-00071 FOR THE SECOND EVENT. REFER TO 2026095-2023-00072 FOR THE THIRD EVENT. REFER TO 2026095-2023-00073 FOR THE FOURTH EVENT. REFER TO 2026095-2023-00074 FOR THE FIFTH EVENT. REFER TO 2026095-2023-00075 FOR THE SIXTH EVENT. REFER TO 2026095-2023-00076 FOR THE SEVENTH EVENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSTION START TIME: (B)(6) 2023 11:07AM, INFECTION STOP TIME: (B)(6) 2023 08:30AM. IT WAS REPORTED THE PUMP INFUSED FASTER THAN THE 46-HOUR TIMEPOINT, AND WHEN THE PUMP RUNS FAST THE PATIENT EXPERIENCES FLUSHING AS A SIDE EFFECT. THERE WAS NO REPORTED INJURY OR MEDICAL INTERVENTION.

  Patient problems: Hot Flashes/Flushes

  MAUDE report 17302955 ↗
• MalfunctionJul 7, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED "THE PUMP INFUSED THE DRUG IN 12-HOURS, WHICH SHOULD HAVE TAKEN 46 HOURS." THE DEVICE WAS IN USE FOR LESS THAT 20-HOURS. ACCORDING TO THE PATIENT, THERE WAS NO MAJOR CHANGE IN TEMPERATURE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17277390 ↗
• MalfunctionJul 5, 2023Insufficient Flow or Under Infusion

  PATIENT CONNECTED TO HOME INFUSIONAL PUMP OF 5-FU ON TUESDAY PER STANDARD OPERATING PROCEDURES. PUMP CONTAINED A VOLUME OF 230ML, (104 ML 5-FU AND 126 ML NS) WHEN PATIENT CAME IN THURSDAY FOR DISCONNECT, THE PUMP HAD ONLY PARTIALLY INFUSED ITS CONTENTS. PUMP WAS EXAMINED BY ONCOLOGY PHARMACIST, RN AND RN NAVIGATOR. ALL CONNECTIONS/LINES WERE CHECKED AND PICC LINE WAS PATENT. ONCOLOGIST WAS INFORMED AND ORDERED TO DC THE PUMP AS IS. THE PICC LINE FLUSHED WELL ONCE PUMP WAS DISCONNECTED. IT IS ESTIMATED THE PATIENT RECEIVED ABOUT HALF OF HIS INFUSIONAL DOSE OF 5-FU (115ML).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17269299 ↗
• MalfunctionJun 12, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 249 ML. FLOW RATE: 5 ML. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: 16MAY2023 AT 1340. INFUSION STOP TIME: 18MAY2023 AT 0100.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17114384 ↗
• MalfunctionMay 17, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FLOW RATE: 5 ML/HR. PROCEDURE: CHEMPOTHERPY. IT WAS REPORTED THE DEVICE INFUSED SOONER THAN EXPECTED. THE PATIENT WAS RECEIVED ON THE UNIT FOR REMOVAL OF THE FLUORURACIL INFUSER. THE DEVICE WAS INSTALLED ON (B)(6) 2023. THE PATIENT REPORTS THE MEDICATION INFUSION ENDED ON (B)(6) 2023. THE PATIENT REPORTED SWEATING A LOT. THE PATIENT ASKED ABOUT THE ADVANCE OF THE END OF MEDICATION CYCLE, "SINCE HE IS IN THE 04 CYCLE OF THE PROTOCOL AND IN THE PREVIOUS ONES THERE WAS NO SUCH EVENT." THERE WAS NO REPORTED INJURY.

  Patient problems: Diaphoresis

  MAUDE report 16949731 ↗
• MalfunctionMar 17, 2023Improper Flow or Infusion; Improper Flow or Infusion

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: ON (B)(6) 2023 14:22. INFUSION STOP TIME: ON (B)(6) 2023 01:30. IT WAS REPORTED, THE INFUSER FINISHED BEFORE THE SCHEDULED TIME. THE 5-FLUOROURACIL WAS ¿INSTALLED IN THE INFUSER¿, AT 2:22 PM WITH AN INFUSION TIME OF 46 HOURS; HOWEVER, THE END OF THE MEDICATION WAS 10 HOURS BEFORE THE SCHEDULED TIME, (01:30 A.M.). THERE WAS NO REPORTED INJURY TO THE PATIENT, WHO FOR THE TIME BEING WAS BEING MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16565002 ↗
• MalfunctionNov 1, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2022-00113 FOR THE FIRST REPORT. FILL VOLUME: 250 ML. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. THE NURSE REPORTED, THE PUMPS THEY USE HAVE BEGUN TO HAVE SPORADIC ISSUES WITH FAST FLOW INCIDENTS. THE NURSE REPORTED THEY WERE USING NOMINAL FILL VOLUMES FOR MEDICATION (CHEMOTHERAPY) TO INFUSE OVER 46 HOURS; THE PATIENT REPORTEDLY RETURNED TWO TO FIVE HOURS EARLY, THERE WERE NO REPORTED SYMPTOMS OR INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15708382 ↗
• MalfunctionNov 1, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2022-00114 FOR THE SECOND REPORT: FILL VOLUME: 250 ML, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. THE NURSE REPORTED, THE PUMPS THEY USE HAVE BEGUN TO HAVE SPORADIC ISSUES WITH FAST FLOW INCIDENTS. THE NURSE REPORTED THEY WERE USING NOMINAL FILL VOLUMES FOR MEDICATION (CHEMOTHERAPY) TO INFUSE OVER 46 HOURS; THE PATIENT REPORTEDLY RETURNED TWO TO FIVE HOURS EARLY, THERE WERE NO REPORTED SYMPTOMS OR INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15708375 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052117. One submission often covers many models, so check the product and lot details in each record.

• Z-2111-2009 · Feb 11, 2008 · Terminated
  I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexico. The Easypump LT is indicated for continuous and/or intermittent infusion of medicatio
• Z-0585-06 · Jan 17, 2006 · Terminated
  Easypump L T 60-24 infusion pump
• Z-0584-06 · Jan 17, 2006 · Terminated
  Easypump ST 100-1 infusion pump