Halyard 13568Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 10680651135688), received between Apr 5, 2017 and Sep 7, 2023 — classified as 1 injury, 85 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (54 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 86 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 270ML FLOW RATE: 5ML/HR PROCEDURE: CHEMOTHERAPY CATHPLACE: UNKNOWN IT WAS REPORTED THE PUMP INFUSED SOONER THAN EXPECTED (12 HOURS AND NOT 44 HOURS), AND THE PATIENT PRESENTED WITH UNSPECIFIED SYMPTOMS. THE PATIENT EXPERIENCED GENERAL MALAISE, EDEMA IN THE FACE AND HAIR LOSS IN ABUNDANT QUANTITIES.

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

  MAUDE report 17701932 ↗
• MalfunctionApr 14, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 125 ML. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. DATE/TIME INFUSION START: (B)(6) 2023, 2:00 PM. DATE/TIME INFUSION ENDED? (B)(6) 2023, 2:00 AM. IT WAS REPORTED "THE INFUSION OF FLUORACIL WAS ANTICIPATED TO COMPLETE THE INFUSION TIME BY 12-HOURS. THE SCHEDULED INFUSION WAS TO END AT 2:00 PM ON (B)(6) 2023, BUT ENDED AT 2:00 AM ON (B)(6) 2023. THE MEDICATION INFUSED IN 46-HOURS. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16743374 ↗
• MalfunctionFeb 8, 2023Infusion or Flow Problem

  OUTPATIENT INFUSION THERAPY STAFF CONNECTED THE HOME ELASTOMERIC PUMP. TWO DAYS LATER WHEN THE PATIENT RETURNED TO HAVE THE PUMP DISCONNECTED, IT WAS NOTED THAT THE MEDICATION WAS STILL IN THE PUMP. ALL CLAMPS WERE OPEN ON TUBING. THE PATIENT¿S VASCULAR ACCESS HAD GOOD BLOOD RETURN AND FLUSHED APPROPRIATELY.

  Patient problems: Insufficient Information

  MAUDE report 16321768 ↗
• MalfunctionSep 24, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 240 ML, FLOW RATE: 5 ML/HR , PROCEDURE: UNKNOWN , CATHPLACE: UNKNOWN. IT WAS REPORTED THAT A FOLLOW-UP CALL WAS MADE TO THE PATIENT AND IT WAS REPORTED THE INFUSER WAS ALREADY EMPTY; THE INFUSER SHOULD HAVE BEEN APPROXIMATELY IN THE MIDDLE OF THE ADMINISTRATION AND NOT EMPTY.

  Patient problems: Insufficient Information

  MAUDE report 15476817 ↗
• MalfunctionMar 4, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 241ML, FLOW RATE: 5ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THE "PATIENT CALLED PHARMACIST TO LET THEM KNOW THAT THE PUMP INFUSION WAS COMPLETE," THE PUMP INFUSED OVER 23.5 HOURS INSTEAD OF THE SCHEDULED 72-HOURS." THE PATIENT WAS ADMITTED INTO THE HOSPITAL, BUT THE PHARMACIST WAS UNAWARE OF WHAT SYMPTOMS WERE EXPERIENCED. THE PATIENT IS RECEIVING AN ANTIDOTE WHILE IN THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 13668120 ↗
• MalfunctionNov 9, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2020-00125 FOR THE FIRST REPORT. FILL VOLUME: UNKNOWN; FLOW RATE: UNKNOWN; PROCEDURE: UNKNOWN; CATHPLACE: UNKNOWN; INFUSION START TIME: UNKNOWN; INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE MEDICATION FLOWED 10 HOURS FASTER THAN USUAL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10813952 ↗
• MalfunctionNov 9, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2020-00126 FOR THE SECOND REPORT. FILL VOLUME: UNKNOWN ; FLOW RATE: UNKNOWN; PROCEDURE: UNKNOWN; CATHPLACE: UNKNOWN; INFUSION START TIME: UNKNOWN; INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE MEDICATION FLOWED 10 HOURS FASTER THAN USUAL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10813883 ↗
• MalfunctionJun 4, 2020Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 241ML. FLOW RATE: 5 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THE DEVICE INFUSED EARLIER THAN EXPECTED. THE PATIENT'S PORTABLE INFUSION PUMP FINISHED AT 08:00 A.M. (B)(6) 2020 AND THE SCHEDULED TIME FOR COMPLETION WAS (B)(6) 2020 AT 11:30 A.M. THERE WAS NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10121416 ↗
• MalfunctionMay 28, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2020-00075 FOR THE FIRST REPORT. REFER TO 2026095-2020-00077 FOR THE THIRD REPORT. FILL VOLUME: 240 ML, FLOW RATE: 5 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT A PATIENT HAD A "PUMP EMPTYING TOO EARLY ON A FEW OCCASIONS." NO ADDITIONAL INFORMATION WAS AVAILABLE REGARDING THIS INCIDENT. PATIENT IS STABLE AND REPORTED NO SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10099199 ↗
• MalfunctionMay 28, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2020-00076 FOR THE SECOND REPORT. REFER TO 2026095-2020-00077 FOR THE THIRD REPORT. FILL VOLUME: 240 ML. FLOW RATE: 5 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: (B)(6) 2020 13:00. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT A PATIENT HAD A "PUMP EMPTYING TOO EARLY ON A FEW OCCASIONS." "IT WAS SUPPOSED TO RUN OVER 48 HOURS, GOT CONNECTED AT 1PM ON TUESDAY [(B)(6) 2020] AND LAST NIGHT [(B)(6) 2020] HE HAD TAKEN A PICTURE OF IT WHICH APPEARED MOSTLY EMPTY AT 10PM. THEY BELIEVE IT SEEMS EMPTY AROUND 24 HOURS AFTER CONNECTION." NO PATIENT INJURY WAS REPORTED. THE PHARMACIST STATED THE PATIENT WAS "FLYING ON A PLANE WHILE THE MEDICATION WAS INFUSING, NOT SURE IF THAT WOULD CHANGE THE FLOW RATE." PATIENT IS STABLE AND REPORTED NO SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10099148 ↗
• MalfunctionMay 28, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2020-00075 FOR THE FIRST REPORT. REFER TO 2026095-2020-00076 FOR THE SECOND REPORT. FILL VOLUME: 240 ML. FLOW RATE: 5 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT A PATIENT HAD A "PUMP EMPTYING TOO EARLY ON A FEW OCCASIONS." NO ADDITIONAL INFORMATION WAS AVAILABLE REGARDING THIS INCIDENT. PATIENT IS STABLE AND REPORTED NO SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10099128 ↗
• MalfunctionMar 2, 2020Inaccurate Flow Rate; Inaccurate Flow Rate

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN , PROCEDURE: UNKNOWN , CATHPLACE: UNKNOWN , INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2020-00032 FOR THE FIRST REPORT . IT WAS REPORTED THAT THE PATIENT'S PUMP EMPTIED FIVE HOURS BEFORE THE SCHEDULED INFUSION STOP TIME. THE PATIENT STATED HE EXPERIENCED ACCELERATED SYMPTOMS, BUT HAD NO LONG TERM EFFECTS.

  Patient problems: No Code Available

  MAUDE report 9778003 ↗
• MalfunctionMar 2, 2020Inaccurate Flow Rate; Inaccurate Flow Rate

  ADDITIONAL INFORMATION RECEIVED 14-APR-2020 INDICATED THE PATIENT IS "DOING WELL."

  Patient problems: No Code Available

  MAUDE report 9777999 ↗
• MalfunctionFeb 17, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED ELEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ELEVEN DIFFERENT EVENTS. THIS IS THE NINTH OF ELEVEN REPORTS. REFER TO 2026095-2020-00013 FOR THE FIRST EVENT. REFER TO 2026095-2020-00014 FOR THE SECOND EVENT. REFER TO 2026095-2020-00015 FOR THE THIRD EVENT. REFER TO 2026095-2020-00016 FOR THE FOURTH EVENT. REFER TO 2026095-2020-00017 FOR THE FIFTH EVENT. REFER TO 2026095-2020-00018 FOR THE SIXTH EVENT. REFER TO 2026095-2020-00019 FOR THE SEVENTH EVENT. REFER TO 2026095-2020-00020 FOR THE EIGHTH EVENT. REFER TO 2026095-2020-00022 FOR THE TENTH EVENT. REFER TO 2026095-2020-00023 FOR THE ELEVENTH EVENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, DATE & TIME CONNECTED: (B)(6) 2018 AT 1254. IT WAS REPORTED A FAST FLOW EVENT OCCURRED. THE DEVICE INFUSED 12-HOURS EARLIER THAN EXPECTED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9716371 ↗
• MalfunctionFeb 14, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED ELEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ELEVEN DIFFERENT EVENTS. THIS IS THE EIGHTH OF ELEVEN REPORTS. REFER TO 2026095-2020-00013 FOR THE FIRST EVENT. REFER TO 2026095-2020-00014 FOR THE SECOND EVENT. REFER TO 2026095-2020-00015 FOR THE THIRD EVENT. REFER TO 2026095-2020-00016 FOR THE FOURTH EVENT. REFER TO 2026095-2020-00017 FOR THE FIFTH EVENT. REFER TO 2026095-2020-00018 FOR THE SIXTH EVENT. REFER TO 2026095-2020-00019 FOR THE SEVENTH EVENT. REFER TO 2026095-2020-00021 FOR THE NINTH EVENT. REFER TO 2026095-2020-00022 FOR THE TENTH EVENT. REFER TO 2026095-2020-00023 FOR THE ELEVENTH EVENT. FILL VOLUME: 249ML, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, DATE & TIME CONNECTED: (B)(6) 2019 AT 12:15. IT WAS REPORTED A FAST FLOW EVENT OCCURRED. THE DEVICE INFUSED 12-HOURS EARLIER THAN EXPECTED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714966 ↗
• MalfunctionFeb 14, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED ELEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ELEVEN DIFFERENT EVENTS. THIS IS THE SIXTH OF ELEVEN REPORTS. REFER TO 2026095-2020-00013 FOR THE FIRST EVENT. REFER TO 2026095-2020-00014 FOR THE SECOND EVENT. REFER TO 2026095-2020-00015 FOR THE THIRD EVENT. REFER TO 2026095-2020-00016 FOR THE FOURTH EVENT. REFER TO 2026095-2020-00017 FOR THE FIFTH EVENT. REFER TO 2026095-2020-00019 FOR THE SEVENTH EVENT. REFER TO 2026095-2020-00020 FOR THE EIGHTH EVENT. REFER TO 2026095-2020-00021 FOR THE NINTH EVENT. REFER TO 2026095-2020-00022 FOR THE TENTH EVENT. REFER TO 2026095-2020-00023 FOR THE ELEVENTH EVENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, DATE & TIME CONNECTED: (B)(6) 2019 AT 1337. IT WAS REPORTED A FAST FLOW EVENT OCCURRED. THE DEVICE INFUSED 10-HOURS EARLIER THAN EXPECTED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714965 ↗
• MalfunctionFeb 14, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED ELEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ELEVEN DIFFERENT EVENTS. THIS IS THE ELEVENTH OF ELEVEN REPORTS. REFER TO 2026095-2020-00013 FOR THE FIRST EVENT. REFER TO 2026095-2020-00014 FOR THE SECOND EVENT. REFER TO 2026095-2020-00015 FOR THE THIRD EVENT. REFER TO 2026095-2020-00016 FOR THE FOURTH EVENT. REFER TO 2026095-2020-00017 FOR THE FIFTH EVENT. REFER TO 2026095-2020-00018 FOR THE SIXTH EVENT. REFER TO 2026095-2020-00019 FOR THE SEVENTH EVENT. REFER TO 2026095-2020-00020 FOR THE EIGHTH EVENT. REFER TO 2026095-2020-00021 FOR THE NINTH EVENT. REFER TO 2026095-2020-00022 FOR THE TENTH EVENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, DATE & TIME CONNECTED: (B)(6) 2019. IT WAS REPORTED A FAST FLOW EVENT OCCURRED. THE DEVICE INFUSED 8-HOURS EARLIER THAN EXPECTED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714964 ↗
• MalfunctionFeb 14, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED ELEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ELEVEN DIFFERENT EVENTS. THIS IS THE TENTH OF ELEVEN REPORTS. REFER TO 2026095-2020-00013 FOR THE FIRST EVENT. REFER TO 2026095-2020-00014 FOR THE SECOND EVENT. REFER TO 2026095-2020-00015 FOR THE THIRD EVENT. REFER TO 2026095-2020-00016 FOR THE FOURTH EVENT. REFER TO 2026095-2020-00017 FOR THE FIFTH EVENT. REFER TO 2026095-2020-00018 FOR THE SIXTH EVENT. REFER TO 2026095-2020-00019 FOR THE SEVENTH EVENT. REFER TO 2026095-2020-00020 FOR THE EIGHTH EVENT. REFER TO 2026095-2020-00021 FOR THE NINTH EVENT. REFER TO 2026095-2020-00023 FOR THE ELEVENTH EVENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, DATE & TIME CONNECTED: (B)(6) 2019 AT 1644. IT WAS REPORTED A FAST FLOW EVENT OCCURRED. THE DEVICE INFUSED 24-HOURS EARLIER THAN EXPECTED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714963 ↗
• MalfunctionFeb 14, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED ELEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ELEVEN DIFFERENT EVENTS. THIS IS THE SEVENTH OF ELEVEN REPORTS. REFER TO 2026095-2020-00013 FOR THE FIRST EVENT. REFER TO 2026095-2020-00014 FOR THE SECOND EVENT. REFER TO 2026095-2020-00015 FOR THE THIRD EVENT. REFER TO 2026095-2020-00016 FOR THE FOURTH EVENT. REFER TO 2026095-2020-00017 FOR THE FIFTH EVENT. REFER TO 2026095-2020-00018 FOR THE SIXTH EVENT. REFER TO 2026095-2020-00020 FOR THE EIGHTH EVENT. REFER TO 2026095-2020-00021 FOR THE NINTH EVENT. REFER TO 2026095-2020-00022 FOR THE TENTH EVENT. REFER TO 2026095-2020-00023 FOR THE ELEVENTH EVENT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, DATE & TIME CONNECTED: (B)(6) 2019 AT 1720. IT WAS REPORTED A FAST FLOW EVENT OCCURRED. THE DEVICE INFUSED OVERNIGHT EARLIER THAN EXPECTED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714962 ↗
• MalfunctionFeb 14, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED ELEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ELEVEN DIFFERENT EVENTS. THIS IS THE SECOND OF ELEVEN REPORTS. REFER TO 2026095-2020-00013 FOR THE FIRST EVENT. REFER TO 2026095-2020-00015 FOR THE THIRD EVENT. REFER TO 2026095-2020-00016 FOR THE FOURTH EVENT. REFER TO 2026095-2020-00017 FOR THE FIFTH EVENT. REFER TO 2026095-2020-00018 FOR THE SIXTH EVENT. REFER TO 2026095-2020-00019 FOR THE SEVENTH EVENT. REFER TO 2026095-2020-00020 FOR THE EIGHTH EVENT. REFER TO 2026095-2020-00021 FOR THE NINTH EVENT. REFER TO 2026095-2020-00022 FOR THE TENTH EVENT. REFER TO 2026095-2020-00023 FOR THE ELEVENTH EVENT. FILL VOLUME: 241 ML, FLOW RATE: 5ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, DATE & TIME CONNECTED: (B)(6) 2019 AT 1352. IT WAS REPORTED A FAST FLOW EVENT OCCURRED. THE DEVICE INFUSED IN LESS THAN 7-HOURS. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714961 ↗
• MalfunctionFeb 14, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED ELEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ELEVEN DIFFERENT EVENTS. THIS IS THE FIFTH OF ELEVEN REPORTS. REFER TO 2026095-2020-00013 FOR THE FIRST EVENT. REFER TO 2026095-2020-00014 FOR THE SECOND EVENT. REFER TO 2026095-2020-00015 FOR THE THIRD EVENT. REFER TO 2026095-2020-00016 FOR THE FOURTH EVENT. REFER TO 2026095-2020-00018 FOR THE SIXTH EVENT. REFER TO 2026095-2020-00019 FOR THE SEVENTH EVENT. REFER TO 2026095-2020-00020 FOR THE EIGHTH EVENT. REFER TO 2026095-2020-00021 FOR THE NINTH EVENT. REFER TO 2026095-2020-00022 FOR THE TENTH EVENT. REFER TO 2026095-2020-00023 FOR THE ELEVENTH EVENT. FILL VOLUME: UNKNOWN, FLOW RATE: 5ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, DATE & TIME CONNECTED: (B)(6) 2019 AT 1734. IT WAS REPORTED A FAST FLOW EVENT OCCURRED. THE DEVICE INFUSED 10-HOURS EARLIER THAN EXPECTED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714960 ↗
• MalfunctionFeb 14, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED ELEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ELEVEN DIFFERENT EVENTS. THIS IS THE FOURTH OF ELEVEN REPORTS. REFER TO 2026095-2020-00013 FOR THE FIRST EVENT. REFER TO 2026095-2020-00014 FOR THE SECOND EVENT. REFER TO 2026095-2020-00015 FOR THE THIRD EVENT. REFER TO 2026095-2020-00017 FOR THE FIFTH EVENT. REFER TO 2026095-2020-00018 FOR THE SIXTH EVENT. REFER TO 2026095-2020-00019 FOR THE SEVENTH EVENT. REFER TO 2026095-2020-00020 FOR THE EIGHTH EVENT. REFER TO 2026095-2020-00021 FOR THE NINTH EVENT. REFER TO 2026095-2020-00022 FOR THE TENTH EVENT. REFER TO 2026095-2020-00023 FOR THE ELEVENTH EVENT. FILL VOLUME: UNKNOWN, FLOW RATE: 5ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, DATE & TIME CONNECTED: (B)(6) 2019 AT 13:16. IT WAS REPORTED A FAST FLOW EVENT OCCURRED. THE DEVICE INFUSED 7-HOURS EARLIER THAN EXPECTED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714959 ↗
• MalfunctionFeb 14, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED ELEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ELEVEN DIFFERENT EVENTS. THIS IS THE THIRD OF ELEVEN REPORTS. REFER TO 2026095-2020-00013 FOR THE FIRST EVENT. REFER TO 2026095-2020-00014 FOR THE SECOND EVENT. REFER TO 2026095-2020-00016 FOR THE FOURTH EVENT. REFER TO 2026095-2020-00017 FOR THE FIFTH EVENT. REFER TO 2026095-2020-00018 FOR THE SIXTH EVENT. REFER TO 2026095-2020-00019 FOR THE SEVENTH EVENT. REFER TO 2026095-2020-00020 FOR THE EIGHTH EVENT. REFER TO 2026095-2020-00021 FOR THE NINTH EVENT. REFER TO 2026095-2020-00022 FOR THE TENTH EVENT. REFER TO 2026095-2020-00023 FOR THE ELEVENTH EVENT. FILL VOLUME: 241 ML, FLOW RATE: 5ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, DATE & TIME CONNECTED: (B)(6) 2019 AT 1449. IT WAS REPORTED A FAST FLOW EVENT OCCURRED. THE DEVICE INFUSED IN 37-HOURS, 9-HOURS EARLIER THAN EXPECTED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714958 ↗
• MalfunctionFeb 14, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED ELEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ELEVEN DIFFERENT EVENTS. THIS IS THE FIRST OF ELEVEN REPORTS. REFER TO 2026095-2020-00014 FOR THE SECOND EVENT. REFER TO 2026095-2020-00015 FOR THE THIRD EVENT. REFER TO 2026095-2020-00016 FOR THE FOURTH EVENT. REFER TO 2026095-2020-00017 FOR THE FIFTH EVENT. REFER TO 2026095-2020-00018 FOR THE SIXTH EVENT. REFER TO 2026095-2020-00019 FOR THE SEVENTH EVENT. REFER TO 2026095-2020-00020 FOR THE EIGHTH EVENT. REFER TO 2026095-2020-00021 FOR THE NINTH EVENT. REFER TO 2026095-2020-00022 FOR THE TENTH EVENT. REFER TO 2026095-2020-00023 FOR THE ELEVENTH EVENT. FILL VOLUME: 241 ML, FLOW RATE: 5ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, DATE & TIME CONNECTED: (B)(6) 2019 AT 1610. IT WAS REPORTED A FAST FLOW EVENT OCCURRED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714957 ↗
• MalfunctionFeb 12, 2020Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 100ML TO INFUSE FOR OVER 46-HOURS. FLOW RATE: 2ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. 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 2026095-2020-00010 FOR THE FIRST EVENT. IT WAS REPORTED THE MEDICATION FLOWED IN FASTER THAN EXPECTED. THE CLINICIANS DO TAPE THE FLOW CONTROLLER TO THE PATIENT'S ABDOMEN, AND SOME OF THE PATIENTS HAVE SAID THAT WHEN THEY TOOK THE CONTROLLER OFF, THE FLOW WOULD SLOW. ADDITIONAL INFORMATION RECEIVED 31-JAN-2020 STATED THERE WERE NO KNOWN MEDICAL ISSUES ASSOCIATED WITH THE INCREASE IN RATE ADMINISTERED. NO MEDICAL TREATMENT WAS REQUIRED. THE PATIENT'S WERE INSTRUCTED TO KEEP THE PUMP AT ROOM TEMPERATURE AND NOT PLACE IT UNDER THE COVERS OR UNDER CLOTHING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9700437 ↗

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