Halyard 13566Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10680651135664), received between Aug 25, 2017 and Jun 4, 2020 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (17 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. 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 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 2026095-2020-00082 FOR THE SECOND REPORT FILL VOLUME: 201 ML, FLOW RATE: 2 ML/HR, PROCEDURE: CHEMOTHERAPY, CATHPLACE: UNKNOWN, INFUSION START TIME: (B)(6) 2020, 0904, INFUSION STOP TIME: (B)(6) 2020, 0900. IT WAS REPORTED THAT THE PATIENT EXPERIENCED FAST FLOW WITH A PUMP FILLED WITH SALINE AND 5FU[FLUOROURACIL]. "STATES PUMP FILLED WITH 201CC IN AN EFFORT TO ACHIEVE A 96 HOUR DELIVERY RATE, PER IFU FILLING TABLE, BUT PATIENT RETURNED BACK TO CLINIC ONE DAY EARLY. NO INJURY OR SYMPTOMS." PHARMACIST STATED THEY ROUTINELY ADD HEPARIN 4000 UNITS TO THE 5FU/SALINE PUMPS THAT INFUSE OVER 4-7 DAYS. ADDITIONAL INFORMATION RECEIVED 15-MAY-2020 INDICATED "PATIENT HAD PUMP ATTACHED ON (B)(6) 2020, THEN PRESENTED TO INFUSION CENTER 1 DAY EARLY AS THE PUMP APPEARED TO BE COMPLETELY EMPTY. THE NURSE CORROBORATED THAT ALL CONNECTIONS, CLAMPS, ETC. WERE CONNECTED PROPERLY AND APPEARED TO BE IN WORKING ORDER. THE PATIENT WILL RETURN TO THE INFUSION CLINIC FOR RE-TREATMENT." PUMP WAS LOCATED OUTSIDE P

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10121415 ↗
• MalfunctionJun 4, 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 2026095-2020-00081 FOR THE FIRST REPORT. FILL VOLUME: 201 ML. FLOW RATE: 2 ML/HR. PROCEDURE: CHEMOTHERAPY. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE PATIENT EXPERIENCED FAST FLOW WITH A PUMP FILLED WITH SALINE AND 5FU[FLUOROURACIL]. "STATES PUMP FILLED WITH 201CC IN AN EFFORT TO ACHIEVE A 96 HOUR DELIVERY RATE, PER IFU FILLING TABLE, BUT PATIENT RETURNED BACK TO CLINIC ONE DAY EARLY. NO INJURY OR SYMPTOMS." PHARMACIST STATED THEY ROUTINELY ADD HEPARIN 4000 UNITS TO THE 5FU/SALINE PUMPS THAT INFUSE OVER 4-7 DAYS. FURTHER DETAILS WERE NOT PROVIDED REGARDING THE INFUSION START AND STOP TIME AND USE OF THIS PUMP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10121414 ↗
• MalfunctionMay 28, 2020Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 201 ML, FLOW RATE: 96 ML/HR, PROCEDURE: CHEMOTHERAPY , CATHPLACE: UNKNOWN, INFUSION START TIME: 04-MAY-2020 11:00, INFUSION STOP TIME: (B)(6) 2020 09:00. IT WAS REPORTED THAT THE PATIENT'S PUMP "FINISHED ABOUT 1 DAY EARLIER THAN IT WAS SUPPOSED TO." "PATIENT HAD PUMP ATTACHED ON (B)(6) 2020, THEN PRESENTED TO INFUSION CENTER 1 DAY EARLY AS THE PUMP APPEARED TO BE COMPLETELY EMPTY. THE NURSE CORROBORATED THAT ALL CONNECTIONS, CLAMPS, ETC. WERE CONNECTED PROPERLY AND APPEARED TO BE IN WORKING ORDER. THE PATIENT WILL RETURN TO THE INFUSION CLINIC FOR RE-TREATMENT WITH A NEW PUMP NEXT MONDAY." NO PATIENT INJURY WAS REPORTED. PATIENT WAS EDUCATED ON HOW TO USE THE DEVICE; IT WAS THE PATIENT'S NINTH TIME USING THIS STYLE PUMP. ADDITIONAL INFORMATION WAS RECEIVED 22-MAY-2020 AS FDA MEDWATCH/ FDA USER FACILITY REPORT MW5094439. THE REPORT STATES "PATIENT HAD HALYARD C ELASTOMERIC PUMP ATTACHED FOR 5-FLUOROURACIL EXTENDED INFUSION ON [DATE REDACTED], THEN PRESENTED TO INFUSION CENTER 1 DAY EARLY AS THE PUMP APPEARED TO BE COMPLETELY EMPTY. THE NURSE CORROBORATED THAT ALL CONNECTIONS, CLAMPS, ETC. WERE CONNECTED PROPERLY AND APPEARED TO BE IN WORKING ORDER. THE PATIENT WILL RETU

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10097230 ↗
• MalfunctionApr 22, 2020Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 243 ML, FLOW RATE: 2ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. DATE & TIME INFUSION START: (B)(6) 2020, TIME NOT PROVIDED. DATE & TIME INFUSION ENDED: (B)(6) 2020, TIME NOT PROVIDED. IT WAS REPORTED THE DEVICE WAS CONNECTED ON WEDNESDAY AND FINISHED ON SATURDAY (3-DAYS INSTEAD OF 5-DAYS). THE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED 31-MAR-2020 STATED THE DEVICE SHOULD HAVE INFUSED FOR 120-HOURS/5-DAYS. ADDITIONAL INFORMATION RECEIVED 02-APR-2020 STATED THERE WERE NO USER OR FACILITY CONDITIONS CONTRIBUTING TO THE INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988945 ↗
• MalfunctionApr 8, 2020Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 201ML. FLOW RATE: 2ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. START TIME: (B)(6) 2020 AT 1:45 P.M. END TIME: (B)(6) 2020 AT 2:00 P.M. (EXPECTED END DATE ON (B)(6) 2020). EXPECTED DOSAGE 4890MG. DELIVERED DOSAGE 4890MG. IT WAS REPORTED THE PUMP INFUSED FASTER THEN USUAL. THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9940592 ↗
• MalfunctionApr 8, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 309 ML, FLOW RATE: 2 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT A FAST FLOW EVENT OCCURRED WITH THE PATIENT'S PUMP; THE "7 DAY FILL INFUSED IN 5 DAYS." NO PATIENT INJURY WAS REPORTED. PATIENT WAS INSTRUCTED IN ALL FACTORS AFFECTING FLOW RATE: TEMPERATURE, POSITIONING OF PUMP, AND EXTERNAL PRESSURE. PATIENT ACKNOWLEDGED UNDERSTANDING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9935451 ↗
• MalfunctionApr 5, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 2026095-2020-00050 FOR THE FIRST EVENT. REFER TO 2026095-2020-00051 FOR THE SECOND EVENT. REFER TO 2026095-2020-00053 FOR THE FOURTH EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: 2 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED A FAST FLOW EVENT OCCURRED, THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9927136 ↗
• MalfunctionApr 5, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 2026095-2020-00050 FOR THE FIRST EVENT. REFER TO 2026095-2020-00052 FOR THE THIRD EVENT. REFER TO 2026095-2020-00053 FOR THE FOURTH EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: 2 ML/HR . PROCEDURE: UNKNOWN . CATHPLACE: UNKNOWN. IT WAS REPORTED A FAST FLOW EVENT OCCURRED, THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9927134 ↗
• MalfunctionApr 5, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 2026095-2020-00050 FOR THE FIRST EVENT. REFER TO 2026095-2020-00051 FOR THE SECOND EVENT. REFER TO 2026095-2020-00052 FOR THE THIRD EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: 2 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED A FAST FLOW EVENT OCCURRED, THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9927133 ↗
• MalfunctionApr 5, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 2026095-2020-00051 FOR THE SECOND EVENT. REFER TO 2026095-2020-00052 FOR THE THIRD EVENT. REFER TO 2026095-2020-00053 FOR THE FOURTH EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: 2 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED A FAST FLOW EVENT OCCURRED, THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9927126 ↗
• MalfunctionApr 3, 2020Improper Flow or Infusion; Improper Flow or Infusion

  FILL VOLUME: 309 ML. FLOW RATE: 2 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT A "7 DAY PUMP INFUSE[D] IN 5 DAYS. NO LEAKAGE DETECTED ANYWHERE." ADDITIONAL INFORMATION RECEIVED 18-MAR-2020 INDICATED THAT "PATIENT WAS RE-INSTRUCTED IN ALL FACTORS AFFECTING FLOW RATE: TEMPERATURE, POSITIONING OF PUMP, AND EXTERNAL PRESSURE...NO INJURY TO PATIENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9920562 ↗
• MalfunctionMar 30, 2020Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW5092908 RECEIVED ON AND THE FOLLOWING INFORMATION WAS PROVIDED: PT ARRIVES ON MONDAY FOR A[N] INFUSER TO RUN UNTIL FRIDAY. PT SHOWS UP ON 2-6 AND PRODUCT EMPTY. (B)(4). NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9896811 ↗
• MalfunctionMar 19, 2020Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 201ML. FLOW RATE: 2ML/HR. PROCEDURE: CHEMOTHERAP. CATHPLACE: UNKNOWN. IT WAS REPORTED A PUMP SET AT 2 ML/HR FOR 96-HOURS BUT THE DEVICE INFUSED OVER ABOUT 48 HOURS. THE PUMP WAS INTENDED TO BE INITIATED ON MONDAY AND REMOVED ON FRIDAY. THE PATIENT REPORTED TO THE CLINIC ON THURSDAY AFTERNOON STATING THAT THE PUMP WAS COMPLETELY EMPTY SOMETIME WEDNESDAY NIGHT. THE PATIENT EXPERIENCED SYMPTOMS OF "FAST FLOW" AND THE CLINIC TREATED THE PATEINT WITH "HYDRATION". ADDITIONAL INFORMATION RECEIVED 24-FEB-2020 NOTED THE PHARMACIST STATED THE PATIENT EXPERIENCED "NEUROLOGIC SYMPTOMS," NAUSEA, MOUTH SORES AND FATIGUE. THE PATIENT RETURNED TODAY FOR HYDRATION AND WILL CONTINUE TO BE MONITORED UNTIL THE NEXT CHEMOTHERAPY CYCLE WHICH IS DUE ON B)(6) 2020.

  Patient problems: Fatigue; Nausea; No Code Available

  MAUDE report 9858054 ↗
• MalfunctionNov 21, 2019Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 243CC. FLOW RATE: 2ML/HR. PROCEDURE: CHEMOTHERAPY. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PATIENT'S PUMP WAS SUPPOSED TO INFUSE IN 120-HOURS BUT THE PATIENT CAME IN ON FRIDAY MORNING AND THE PUMP WAS EMPTY. THE PUMP EMPTIED 24-HOURS EARLY ACCORDING TO THE PHARMACY. THE PATIENT WAS STABLE WITH NO SIDE EFFECTS FROM THE MEDICATION INFUSING IN TOO FAST.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9357159 ↗
• MalfunctionNov 20, 2019Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 243 ML. FLOW RATE: 2ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THE HOMEPUMP PATIENT CAME IN ON DAY 4 OF A 5-DAY THERAPY TREATMENT AND THE DEVICE WAS EMPTY. THE PATIENT WAS STABLE WITH NO SIDE EFFECTS OF THE MEDICATION INFUSING TOO FAST. THE PHARMACIST STATED THAT THIS PATIENT'S DOSE WAS VERY LOW BUT THE FILL VOLUME WAS WITHIN CHART SPECIFICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9349302 ↗
• MalfunctionNov 13, 2019Infusion or Flow Problem; Infusion or Flow Problem

  FDA MEDWATCH MW5091408 RECEIVED STATING (PHARMACIST REPORTS): AVANOS HOMEPUMP C-SERIES PUMP INFUSED IN TOO QUICKLY. THE PT WAS STARTED O MONDAY AND DE-ACCESSED ON THE FRIDAY. THERE SHOULD HAVE BEEN ENOUGH DRUG IN THE PUMP FOR (B)(4) ADD'L DAY AS THE PUMP WAS FILLED FOR (B)(4) DAYS. THIS INCIDENT ALSO OCCURRED ON (B)(4) SUBSEQUENT TREATMENTS EACH INCIDENT WAS REPORTED TO THE COMPANY. THE COMPANY SENT RETURN BOXES TO RETRIEVE THE PUMPS FOR TESTING PURPOSES TO DATE NO TESTING INFO HAS BEEN FORWARDED TO OUR FACILITY FOR REVIEW. I FOLLOWED UP WITH THE COMPANY BUT THEY DID NOT HAVE ANY INFO CONCERNING THE THREE PUMPS. THE ADDITIONAL INCIDENTS REFERENCED WERE PREVIOUSLY REPORTED IN MEDWATCH REPORTS 2026095-2019-00183, 2026095-2019-00184 AND 2026095-2019-00186.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9315579 ↗
• MalfunctionJun 4, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN; FLOW RATE: UNKNOWN; PROCEDURE: UNKNOWN; CATHPLACE: UNKNOWN; INFUSION START TIME: UNKNOWN; INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE DEVICE "WITH 5-DAY INFUSION OF 5FU [FLUOROURACIL] AND NS [NORMAL SALINE] INFUSED FASTER THAN DESIRED." ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019 INDICATED THE PATIENT EXPERIENCED NAUSEA, SHORTNESS OF BREATH, AND RASH THAT APPEARED OVER TORSO AND UNDER PORT DRESSING AFTER PUMP CONNECTION. INTERVENTION CONSISTED OF "IV EMEND, CT [COMPUTED TOMOGRAPHY] TO R/O [RULE OUT] PE [PULMONARY EMBOLISM], O2 SAT [OXYGEN SATURATION] MONITORING IN CLINIC."

  Patient problems: Dyspnea; Nausea; Rash

  MAUDE report 8665929 ↗
• MalfunctionMay 30, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 211 ML; FLOW RATE: 2ML/HR; PROCEDURE: CHEMO TREATMENT; CATHPLACE: UNKNOWN; INFUSION START TIME: 1502 ON (B)(6) 2019 INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE PUMP WAS PLACED (B)(6) 2019 AT 3:02PM. ON (B)(6) 2019 AT 10:50AM THE PATIENT RETURNED FOR F/U [FOLLOW-UP] RELATED TO ANOTHER THERAPY AND NURSE NOTED THAT PUMP WAS EMPTY; IT WAS SCHEDULED TO COMPLETE ON (B)(6) 2019 AT 4:00PM. SAME DAY, (B)(6) 2019, PATIENT HAD F/U WITH CARDIOLOGIST FOR C/O [COMPLAINT OF] CHEST DISCOMFORT. NOTES FROM CARDIOLOGIST REPORT "PT [PATIENT] REPORTED SINCE (B)(6) 2019 EXPERIENCED INTERMITTENT CHEST DISCOMFORT. EXPERIENCED SHARP CHEST DISCOMFORT THE NIGHT OF (B)(6) 2019, RELIEVED WITH MOTRIN. ON THE MORNING OF (B)(6)2019 FURTHER EPISODES OF CHEST DISCOMFORT WHICH WAS SOMEWHAT POSITIONAL, RELIEVED BY SITTING UP STRAIGHT, ALSO AT THIS TIME EXPERIENCED TINGLING IN ARMS. EVALUATED ON (B)(6) 2019, NO CURRENT CHEST DISCOMFORT AT TIME OF EVALUATION BY CARDIOLOGIST. PT. REPORTS PERHAPS MILD SHORTNESS OF BREATH, NO DIAPHORESIS OR OTHER CARDIAC COMPLAINTS. HE DOES NOT HAVE KNOWN ISCHEMIC HEART DISEASE, PROGRESSIVE ANGINA, HEART FAILURE SYMPTOMATOLOGY OR ARRYTHMIA HX [HISTORY]. EKG [ELECTRO

  Patient problems: Chest Pain; Tingling

  MAUDE report 8653565 ↗
• MalfunctionMay 3, 2019Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 201 ML, FLOW RATE: 2ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: PICC LINE, START DATE: (B)(6) 2019 AT 1530, STOP DATE: (B)(6) 2019. IT WAS REPORTED THE PUMP WAS FILLED WITH 20/ML NORMAL SALINE AND 5 FU TO DELIVER OVER 4-DAYS, BUT DEVICE EMPTIED IN ABOUT 2-DAYS PER THE PATIENT. THE CLINICIAN DECREASED CHEMOTHERAPY DOSING FOR THE SUBSEQUENT CYCLES. THERE WAS NO REPORTED INJURY.

  Patient problems: Inflammation

  MAUDE report 8579436 ↗
• MalfunctionJan 18, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2019-00015 FOR THE SECOND PATIENT. REFER TO 2026095-2019-00016 FOR THE THIRD PATIENT. FILL VOLUME: 201 ML, FLOW RATE: 2 ML/HR, PROCEDURE: CHEMOTHERAPY, CATHPLACE: PORT-A-CATH. IT WAS REPORTED THAT A RESPIRATORY THERAPIST HAD A PATIENT WHO EXPERIENCED A FAST FLOW ASSOCIATED WITH THE USE OF AN ELASTOMERIC PUMP. IT WAS NOTED THAT THE PUMP, WHICH WAS A 2 ML/HOUR FLOW RATE, WAS PREPARED FOR A 96 HOUR INFUSION. IT INFUSED FASTER THAN IT SHOULD HAVE. IT COMPLETED IN 48 TO 72 HOURS PER THE PATIENT, WHO WAS SEEN WITH THE EMPTY PUMP ABOUT 88 HOURS AFTER THE START. THE PATIENT STATED THAT IT COMPLETED INFUSION ON WEDNESDAY, BUT HE DID NOT CALL THE FACILITY. THE RESPIRATORY THERAPIST NOTED THAT THIS WAS A VERY HIGH DOSE OF 5FU AND WAS CONCERNED ABOUT THE FAST FLOW RATE. THE MIX WAS VERIFIED AS CORRECT AND MATCHED THE PRODUCT LABELING. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 STATED THAT THE INFUSION WAS STARTED ON MONDAY, (B)(6) 2018. THE PATIENT RETURNED ON FRIDAY FOR A DISCO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8262710 ↗
• MalfunctionJan 18, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2019-00014 FOR THE FIRST PATIENT. REFER TO 2026095-2019-00015 FOR THE SECOND PATIENT. FILL VOLUME: 201 ML, FLOW RATE: 2 ML/HR, PROCEDURE: CHEMOTHERAPY, CATHPLACE: PORT-A-CATH. IT WAS REPORTED THAT A RESPIRATORY THERAPIST HAD A PATIENT WHO EXPERIENCED A FAST FLOW ASSOCIATED WITH THE USE OF AN ELASTOMERIC PUMP. IT WAS NOTED THAT THE PUMP, WHICH WAS A 2ML/HOUR FLOW RATE, WAS PREPARED FOR A 96 HOUR INFUSION. IT INFUSED FASTER THAN IT SHOULD HAVE. IT COMPLETED IN APPROXIMATELY 80 HOURS. THE RESPIRATORY THERAPIST NOTED THAT THIS WAS A VERY HIGH DOSE OF 5FU AND WAS CONCERNED ABOUT THE FAST FLOW RATE. THE MIX WAS VERIFIED AS CORRECT AND MATCHED THE PRODUCT LABELING. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 STATED THAT THE INFUSION WAS STARTED ON MONDAY, (B)(6) 2018. THE PATIENT RETURNED ON FRIDAY FOR A DISCONNECT AND REPORTED THAT HER PUMP FINISHED AROUND 6PM THE EVENING BEFORE. THERE WERE NO REPORTED ABNORMAL USE CONDITIONS AND THE PUMP WAS NOTED TO BE CARRIED IN A WAIST

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8262707 ↗
• MalfunctionJan 18, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2019-00014 FOR THE FIRST PATIENT. REFER TO 2026095-2019-00016 FOR THE THIRD PATIENT. FILL VOLUME: 201 ML, FLOW RATE: 2 ML/HR, PROCEDURE: CHEMOTHERAPY, CATHPLACE: PORT-A-CATH. IT WAS REPORTED THAT A RESPIRATORY THERAPIST HAD A PATIENT WHO EXPERIENCED A FAST FLOW ASSOCIATED WITH THE USE OF AN ELASTOMERIC PUMP. IT WAS NOTED THAT THE PUMP, WHICH WAS A 2ML/HOUR FLOW RATE, WAS PREPARED FOR A 96 HOUR INFUSION. IT INFUSED FASTER THAN IT SHOULD HAVE. IT COMPLETED IN 72 HOURS, WITH THE PATIENT IN THE CLINIC AT THE TIME OF COMPLETION FOR THE STAFF TO SEE THE EMPTY PUMP. THE RESPIRATORY THERAPIST NOTED THAT THIS WAS A VERY HIGH DOSE OF 5FU AND WAS CONCERNED ABOUT THE FAST FLOW RATE. THE MIX WAS VERIFIED AS CORRECT AND MATCHED THE PRODUCT LABELING. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 STATED THAT THE INFUSION WAS STARTED ON MONDAY, (B)(6) 2018. THE PATIENT RETURNED ON WEDNESDAY FOR A DISCONNECT AND REPORTED THAT HIS INFUSION FINISHED SOME TIME IN THE LAST 12 HOURS. THERE W

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8262690 ↗
• MalfunctionAug 9, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: UNKNOWN. FLOW RATE: 2 ML/HOUR. PROCEDURE: UNKNOWN. CATHPLACE: CHEST PORT. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT'S FLUOROURACIL INFUSION PUMP INFUSED OVER THREE DAYS INSTEAD OF THE EXPECTED FOUR DAYS (96 HOURS). NO INJURY TO THE PATIENT REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7766895 ↗
• MalfunctionAug 25, 2017Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 201 ML. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: PERIPHERAL INSERTED CENTRAL CATHETER (PICC). IT WAS REPORTED THAT A PUMP DISPENSED ALL THE MEDICATION IN 72-HOURS, INSTEAD OF 96-HOURS. THE DEVICE FAILED TO INFUSE OVER THE EXPECTED PERIOD. THE PUMP WAS DISPENSED AND ADMINISTERED ON (B)(6)2017, AND FULLY INFUSED IT¿S CONTENTS OVER 72-HOURS, NOT 96 HOURS. ADDITIONAL INFORMATION RECEIVED 03-AUG-2017. NO REPORTED INJURY OR MEDICAL INTERVENTION REQUIRED FROM THE INCIDENT. THE PATIENT'S CONDITION WAS REPORTED AS " UNAFFECTED". NO ADDITIONAL INFORMATION WAS PROVIDED .

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6819917 ↗

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-0584-06 · Jan 17, 2006 · Terminated
  Easypump ST 100-1 infusion pump
• Z-0585-06 · Jan 17, 2006 · Terminated
  Easypump L T 60-24 infusion pump