Halyard 13561Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10680651135619), received between Sep 5, 2017 and Nov 10, 2022 — classified as 2 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (26 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 2026095-2022-00122 FOR THE FIRST EVENT. REFER TO 2026095-2022-00123 FOR THE SECOND EVENT. REFER TO 2026095-2022-00124 FOR THE THIRD EVENT. REFER TO 2026095-2022-00126 FOR THE FIFTH EVENT. FILL VOLUME: 96ML, FLOW RATE: 2ML/HR, PROCEDURE: CHEMOTHERAPY, CATHPLACE: CENTRAL, INFUSION START TIME: (B)(6) 2022 AT 1415, INFUSION STOP TIME: (B)(6) 2022 AT 2200. IT WAS REPORTED THE ON-Q PUMPS INFUSED 16-HOURS FASTER THAN INTENDED. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15771420 ↗
• MalfunctionNov 10, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 2026095-2022-00122 FOR THE FIRST EVENT. REFER TO 2026095-2022-00123 FOR THE SECOND EVENT. REFER TO 2026095-2022-00124 FOR THE THIRD EVENT. REFER TO 2026095-2022-00125 FOR THE FOURTH EVENT. FILL VOLUME: 96ML. FLOW RATE: 2ML/HR. PROCEDURE: CHEMOTHERAPY. CATHPLACE: CENTRAL. INFUSION START TIME: (B)(6) 2022 AT 1630. INFUSION STOP TIME: (B)(6) 2022 AT 0230. IT WAS REPORTED THE ON-Q PUMPS INFUSED 16-HOURS FASTER THAN INTENDED. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15771410 ↗
• MalfunctionNov 10, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 2026095-2022-00122 FOR THE FIRST EVENT. REFER TO 2026095-2022-00123 FOR THE SECOND EVENT. REFER TO 2026095-2022-00125 FOR THE FOURTH EVENT. REFER TO 2026095-2022-00126 FOR THE FIFTH EVENT. FILL VOLUME: 96ML. FLOW RATE: 2ML/HR. PROCEDURE: CHEMOTHERAPY. CATHPLACE: CENTRAL. INFUSION START TIME: (B)(6) 2022 AT 1530. INFUSION STOP TIME: (B)(6) 2022 AT 2300. IT WAS REPORTED THE ON-Q PUMPS INFUSED 16-HOURS FASTER THAN INTENDED. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15771408 ↗
• MalfunctionNov 10, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 2026095-2022-00122 FOR THE FIRST EVENT. REFER TO 2026095-2022-00124 FOR THE THIRD EVENT. REFER TO 2026095-2022-00125 FOR THE FOURTH EVENT. REFER TO 2026095-2022-00126 FOR THE FIFTH EVENT. FILL VOLUME: 96ML, FLOW RATE: 2ML/HR, PROCEDURE: CHEMOTHERPY, CATHPLACE: CENTRAL, INFUSION START TIME: 11-OCT-2022 AT 1320, INFUSION STOP TIME: 12-OCT-2022 AT 2100. IT WAS REPORTED THE ON-Q PUMPS INFUSED 16-HOURS FASTER THAN INTENDED. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15771404 ↗
• MalfunctionNov 10, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 2026095-2022-00123 FOR THE SECOND EVENT. REFER TO 2026095-2022-00124 FOR THE THIRD EVENT. REFER TO 2026095-2022-00125 FOR THE FOURTH EVENT. REFER TO 2026095-2022-00126 FOR THE FIFTH EVENT. FILL VOLUME: 96ML, FLOW RATE: 2ML/HR, PROCEDURE: CHEMOTHERAPY, CATHPLACE: CENTRAL, INFUSION START TIME: (B)(6) 2022 AT 1500, INFUSION STOP TIME: (B)(6) 2022 AT 2200. IT WAS REPORTED THE ON-Q PUMPS INFUSED 16-HOURS FASTER THAN INTENDED. STOMACH PAIN OCCURRED DURING THE INFUSION AND CEASED AFTERWARDS. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: Abdominal Pain

  MAUDE report 15771323 ↗
• MalfunctionAug 30, 2022Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 2026095-2022-00096 FOR THE FIRST EVENT. REFER TO 2026095-2022-00097 FOR THE SECOND EVENT. REFER TO 2026095-2022-00098 FOR THE THIRD EVENT. REFER TO 2026095-2022-00099 FOR THE FOURTH EVENT. FILL VOLUME: 95 ML; FLOW RATE: 2ML/HR; PROCEDURE: UNKNOWN; CATHPLACE: UNKNOWN; START TIME: (B)(6) 2022 AT 6:30PM; STOP TIME: (B)(6) 2022 AT 9:30PM. IT WAS REPORTED A FAST FLOW EVENT OCCURRED DURING USE OF THE ELASTOMERIC PUMP. THE "46H INFUSION ENDED APPROXIMATELY 5 HOURS EARLIER." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15320795 ↗
• MalfunctionAug 30, 2022Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 2026095-2022-00096 FOR THE FIRST EVENT. REFER TO 2026095-2022-00097 FOR THE SECOND EVENT. REFER TO 2026095-2022-00099 FOR THE FOURTH EVENT. REFER TO 2026095-2022-00100 FOR THE FIFTH EVENT. FILL VOLUME: 95 ML. FLOW RATE: 2 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. START TIME:(B)(6) 2022. STOP TIME: (B)(6) 2022. IT WAS REPORTED A FAST FLOW EVENT OCCURRED DURING USE OF THE ELASTOMERIC PUMP. THE "46H INFUSION ENDED APPROXIMATELY 5 HOURS EARLIER." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15320790 ↗
• MalfunctionAug 30, 2022Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 2026095-2022-00096 FOR THE FIRST EVENT. REFER TO 2026095-2022-00097 FOR THE SECOND EVENT. REFER TO 2026095-2022-00098 FOR THE THIRD EVENT. REFER TO 2026095-2022-00100 FOR THE FIFTH EVENT. FILL VOLUME: 95 ML. FLOW RATE: 2ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. START TIME: (B)(6) 2022 AT 7:00PM. STOP TIME: (B)(6) AT 2:00PM. IT WAS REPORTED A FAST FLOW EVENT OCCURRED DURING USE OF THE ELASTOMERIC PUMP. THE "46H INFUSION ENDED APPROXIMATELY 5 HOURS EARLIER." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15320789 ↗
• MalfunctionAug 30, 2022Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 2026095-2022-00096 FOR THE FIRST EVENT. REFER TO 2026095-2022-00098 FOR THE THIRD EVENT. REFER TO 2026095-2022-00099 FOR THE FOURTH EVENT. REFER TO 2026095-2022-00100 FOR THE FIFTH EVENT. FILL VOLUME: 95 ML FLOW RATE: 2ML/HR PROCEDURE: UNKNOWN CATHPLACE: UNKNOWN START TIME: ON (B)(6) 2022 AT 2:00PM STOP TIME: ON (B)(6) 2022 AT 7:30AM IT WAS REPORTED A FAST FLOW EVENT OCCURRED DURING USE OF THE ELASTOMERIC PUMP. THE "46H INFUSION ENDED APPROXIMATELY 5 HOURS EARLIER." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15320781 ↗
• MalfunctionAug 30, 2022Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 2026095-2022-00097 FOR THE SECOND EVENT. REFER TO 2026095-2022-00098 FOR THE THIRD EVENT. REFER TO 2026095-2022-00099 FOR THE FOURTH EVENT. REFER TO 2026095-2022-00100 FOR THE FIFTH EVENT. FILL VOLUME: 95 ML. FLOW RATE: 2ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. START TIME: (B)(6)2022 AT 3:30PM. STOP TIME: (B)(6)2022 AT 8:30AM. IT WAS REPORTED A FAST FLOW EVENT OCCURRED DURING USE OF THE ELASTOMERIC PUMP. "THE 46-HOUR INFUSION ENDED APPROXIMATELY 5 HOURS EARLIER. THE INFUSER WAS INSTALLED ON 07/20 AND, ON 07/22, THE PATIENT CAME TO THE SERVICE 5-HOURS BEFORE THE SCHEDULED TIME WITH THE CONTENTS OF THE BAG COMPLETELY INFUSED, WITHOUT SIGNS OF CONTENT LEAKAGE." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15320776 ↗
• MalfunctionMar 17, 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 THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2022-00011 FOR THE FIRST REPORT. FILL VOLUME: 95ML, FLOW RATE: 2ML/H, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUS EXPERIENCE WITH THE PUMP FINISHING 10 HOURS EARLIER THAN EXPECTED. THE PUMP CONTAINED AN ANTI-CANCER DRUG, 5FU. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13790771 ↗
• MalfunctionMar 3, 2022Excess 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 PUMP FINISHED 10 HOURS EARLIER THAN EXPECTED. THE PUMP CONTAINED AN ANTI-CANCER DRUG. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13663752 ↗
• MalfunctionJul 9, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THE DEVICE INFUSED 10-HOURS AHEAD OF SCHEDULE. THE DEVICE WAS INITIATED ON (B)(6) 2021 AT 1550 AND WAS SCHEDULED TO INFUSE IN 46-HOURS, WITH A SCHEDULED COMPLETION DATE AND TIME OF (B)(6) 2021 AT 1350. HOWEVER, THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2021 AT 0300 AND THE MEDICATION INFUSION WAS COMPLETED. THE PATIENT REPORTS THAT HE FOLLOWED ALL GUIDELINES OF CARE WITH THE INFUSION. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12143126 ↗
• MalfunctionNov 24, 2020Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 95 ML. FLOW RATE: 2ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED A FAST FLOW EVENT OCCURRED. THE ONCOLOGY TEAM NOTED THE DEVICE WAS PLACED ON (B)(6) 2020 AT 15:15 TO INFUSE FOR 46-HOURS, WITH AN EXPECTED COMPLETION DATE OF (B)(6) 2020 AT 13:15. THE PATIENT RETURNED WITH THE EMPTY INFUSION ON (B)(6) 2020 AT 09:06 AM. ADDITIONAL INFORMATION RECEIVED 09-NOV-2020 STATED THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10898589 ↗
• MalfunctionApr 23, 2020Excess 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 THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2020-00060 FOR THE FIRST REPORT. FILL VOLUME: 95ML. FLOW RATE: 2ML/HR. PROCEDURE: 5FU. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE PUMP OF 5FU RAN EMPTY AFTER A DAY INSTEAD OF THE EXPECTED 48 HOURS. THE PATIENT HAS ALLEGED SHE KEEPS THE PUMP IN A SAFE SPOT NEXT TO HER AT NIGHT AND DOES NOT SLEEP ON IT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9990406 ↗
• MalfunctionApr 23, 2020Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 100ML, FLOW RATE: 2ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT "PATIENT REPORTED TO PHARMACY THAT THE MEDICATION FROM PUMP WAS COMPLETED 11 HOURS TOO EARLY. SUPPOSED TO BE INFUSED OVER 46 HOURS. HE SAID HE BECAME DIAPHORETIC, FELT HIS HEARTRATE INCREASE AND WENT TO ER [EMERGENCY ROOM], BUT DID NOT RECEIVE ANY MEDS OR TREATMENT. PATIENT IS FINE AND STABLE AT HOME." ADDITIONAL INFORMATION PROVIDED 13-APR-2020 INCLUDED TWO IMAGES OF THE PUMP. PUMP FILLED WITH FLUOROURACIL.

  Patient problems: Sweating; Tachycardia

  MAUDE report 9990405 ↗
• MalfunctionApr 22, 2020Excess 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 THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2020-00061 FOR THE SECOND REPORT. FILL VOLUME: 95ML, FLOW RATE: 2ML/HR, PROCEDURE: 5FU, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE PUMP OF 5FU RAN EMPTY AFTER A DAY INSTEAD OF THE EXPECTED 48 HOURS. THE PATIENT HAS ALLEGED SHE KEEPS THE PUMP IN A SAFE SPOT NEXT TO HER AT NIGHT AND DOES NOT SLEEP ON IT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988951 ↗
• MalfunctionMar 6, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2020-00036 FOR THE FIRST EVENT. REFER TO 2026095-2020-00038 FOR THE THIRD EVENT. FILL VOLUME: 95 ML, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP FLOWED IN EIGHT HOURS SOONER THAN EXPECTED. THERE WAS NO REPORTED INJURY AND NO SYMPTOMS OF FAST FLOW. THE PATIENT WAS INSTRUCTED TO PUT THE PUMP ON CHEST AT NIGHT WHILE SLEEPING. INSTRUCTED THAT PUMP AND TUBING BE PLACED OUTSIDE OF COVERS WHILE SLEEPING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9799268 ↗
• MalfunctionMar 6, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2020-00036 FOR THE FIRST EVENT. REFER TO 2026095-2020-00037 FOR THE SECOND EVENT. FILL VOLUME: 95 ML. FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP FLOWED IN EIGHT HOURS SOONER THAN EXPECTED. THERE WAS NO REPORTED INJURY AND NO SYMPTOMS OF FAST FLOW. THE PATIENT WAS INSTRUCTED TO PUT THE PUMP ON CHEST AT NIGHT WHILE SLEEPING. INSTRUCTED THAT PUMP AND TUBING BE PLACED OUTSIDE OF COVERS WHILE SLEEPING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9799256 ↗
• MalfunctionMar 6, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2020-00037 FOR THE SECOND EVENT. REFER TO 2026095-2020-00038 FOR THE THIRD EVENT. FILL VOLUME: 95 ML, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP FLOWED IN EIGHT HOURS SOONER THAN EXPECTED. THERE WAS NO REPORTED INJURY AND NO SYMPTOMS OF FAST FLOW. THE PATIENT WAS INSTRUCTED TO PUT THE PUMP ON CHEST AT NIGHT WHILE SLEEPING. INSTRUCTED THAT PUMP AND TUBING BE PLACED OUTSIDE OF COVERS WHILE SLEEPING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9799233 ↗
• InjuryFeb 17, 2020Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP INFUSED TOO QUICKLY (PUMP WAS TO INFUSE OVER 48-HOURS AND FINISHED 24-HOURS EARLY). THE PHARMACIST STATED THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A "CARDIAC EVENT" AS A RESULT OF THE PUMP INFUSING TOO QUICKLY. ADDITIONAL INFORMATION RECEIVED 30-JAN-2020 STATED THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR HEART FAILURE, NON SINUS TACHYCARDIA (ST) ELEVATION MYOCARDIAL INFARCTION (MI) AND PNEUMONIA. THE HEALTHCARE PROVIDER NOTES, "THE CARDIAC SYMPTOMS OCCURRED AROUND THE TIME THE PUMP FAILED (INFUSED TOO FAST) COUPLED WITH [THE] PATIENTS RENAL FAILURE LEADING TO TOXICITY." THE DEVICE WAS LOCATED EXTERIOR OF THE PATIENT CLOTHING. THE PATIENT IS REPORTED TO BE EXTREMELY ANXIOUS DUE TO THE EVENT.

  Patient problems: Anxiety; Cardiac Arrest; Heart Failure; Non specific EKG/ECG Changes; Pneumonia

  MAUDE report 9717970 ↗
• MalfunctionFeb 13, 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. 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 9708431 ↗
• MalfunctionOct 25, 2019Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 100 ML. FLOW RATE: 2ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED A FAST FLOW INCIDENT OCCURRED. THE PUMP WAS TO INFUSE OVER 46-HOURS. PHARMACY STATES THE PUMP WAS EMPTY ABOUT 12-HOURS EARLY. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED 09-OCT-2019 STATED THE INFUSION ENDED EARLY AT 36-HOURS INSTEAD OF THE SCHEDULED 46-HOURS. THE PATIENT WAS OUT MOWING THE GRASS PRIOR TO NOTICING THE PUMP BEING EMPTY. THE FLOW RESTRICTOR WAS TAPED TO PATIENT'S SKIN. THE PUMP WAS LOCATED 12 INCHES BELOW THE CATHETER DURING THE INFUSION. THE PUMP WAS PLACED IN THE FANNY PACK. THEE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9243130 ↗
• MalfunctionJul 5, 2019Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 100ML; FLOW RATE: 2ML/HR; PROCEDURE: UNKNOWN ; CATHPLACE: UNKNOWN. IT WAS REPORTED THE DEVICE WAS TO INFUSE FOR 46-HOURS BUT THE DEVICE COMPLETED THE INFUSION IN 24-HOURS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8764646 ↗
• MalfunctionMay 21, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 95 ML; FLOW RATE: 2 ML/HR; PROCEDURE: UNKNOWN; CATHPLACE: UNKNOWN. INFUSION START TIME: (B)(6) 2019; 1500. INFUSION STOP TIME: (B)(6) 2019; 0600. ADDITIONAL INFORMATION RECEIVED 26-JUN-2019 INCLUDES THE FILL VOLUME, FLOW RATE, AND INFUSION START/STOP TIMES LISTED ABOVE. ACCORDING TO THE COMPLAINANT, INFUSION ENDED AT 6AM "OR SOONER, WHEN PATIENT WOKE UP AT 6AM IT WAS EMPTY SO UNABLE TO SAY EXACTLY WHAT TIME DURING THE NIGHT." DRUG WAS 5FU [FLUOROURACIL] AND NORMAL SALINE, EXPECTED DOSAGE 625MG. DELIVERED DOSAGE WAS LISTED AS "ASSUMPTION IS ENTIRE DOSAGE AS THE PUMP WAS EMPTY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8628395 ↗

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