Halyard 13685Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10680651136852), received between Feb 21, 2018 and Mar 29, 2018 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (19 reports).

3 other recalls cover devices cleared under the same FDA submission (K063530); 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 400 ML, FLOW RATE: 6 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: PORT. HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT PATIENTS. THIS IS THE EIGHTH OF EIGHT REPORTS. PATIENT A - 48 HRS. 2026095-2018-00034 ONLY. PATIENT B - 48 HRS. 2026095-2018-00035 ONLY. PATIENT C - 52.5 HRS. 2026095-2018-00036 ONLY. PATIENT D - 50.5 HRS. 2026095-2018-00037 ONLY. PATIENT E - 50.5 HRS. 2026095-2018-00038 ONLY. PATIENT F - 51.5 HRS. 2026095-2018-00039 ONLY. PATIENT G - LESS THAN 50 HRS. (PATIENT COULD NOT GIVE ME THE EXACT TIME CATHETER WAS REMOVED, BUT WAS DEFINITELY LESS THAN 50 HRS. ADD THIS TO 2026095-2018-00040 ONLY. PATIENT H - PATIENT COULD NOT TELL THE DAY OR TIME CATHETER WAS REMOVED BUT BASED ON OUR DISCUSSIONS AND THE SIZE OF THE PAIN BALL WHEN HE LEFT THE HOSPITAL, I SUSPECT IN THE RANGE OF 50 HRS. ADD THIS TO 2026095-2018-00041 ONLY. THE DOCTOR STATED ¿THE PUMPS ARE INFUSING INCORRECTLY BECAUSE AT 6 ML/HR I WOULD EXPECT SOME OF THEM TO BE CLOSER TO 67 HRS. MOST IF NOT ALL ARE INFUSING FASTER THAN THIS RATE. ADDITIONAL INFORMATION WAS RECEIVED 01-MAR-2018 FROM THE DOCTOR THAT STATED T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7381757 ↗
• MalfunctionMar 29, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 400 ML . FLOW RATE: 6 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: PORT. HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT PATIENTS. THIS IS THE SEVENTH OF EIGHT REPORTS. PATIENT A - 48 HRS. 2026095-2018-00034 ONLY, PATIENT B - 48 HRS. 2026095-2018-00035 ONLY, PATIENT C - 52.5 HRS. 2026095-2018-00036 ONLY, PATIENT D - 50.5 HRS. 2026095-2018-00037 ONLY, PATIENT E - 50.5 HRS. 2026095-2018-00038 ONLY, PATIENT F - 51.5 HRS. 2026095-2018-00039 ONLY, PATIENT G - LESS THAN 50 HRS. (PATIENT COULD NOT GIVE ME THE EXACT TIME CATHETER WAS REMOVED, BUT WAS DEFINITELY LESS THAN 50 HRS. ADD THIS TO 2026095-2018-00040 ONLY, PATIENT H - PATIENT COULD NOT TELL THE DAY OR TIME CATHETER WAS REMOVED BUT BASED ON OUR DISCUSSIONS AND THE SIZE OF THE PAIN BALL WHEN HE LEFT THE HOSPITAL, I SUSPECT IN THE RANGE OF 50 HRS. ADD THIS TO 2026095-2018-00041 ONLY. THE DOCTOR STATED ¿THE PUMPS ARE INFUSING INCORRECTLY BECAUSE AT 6 ML/HR I WOULD EXPECT SOME OF THEM TO BE CLOSER TO 67 HRS. MOST IF NOT ALL ARE INFUSING FASTER THAN THIS RATE. ADDITIONAL INFORMATION WAS RECEIVED 01-MAR-2018 FROM THE DOCTOR THAT STATED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7381752 ↗
• MalfunctionMar 29, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 400 ML. FLOW RATE: 6 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: PORT. HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT PATIENTS. THIS IS THE SIXTH OF EIGHT REPORTS. PATIENT B - 48 HRS. 2026095-2018-00035 ONLY, PATIENT C - 52.5 HRS. 2026095-2018-00036 ONLY, PATIENT D - 50.5 HRS. 2026095-2018-00037 ONLY, PATIENT E - 50.5 HRS. 2026095-2018-00038 ONLY, PATIENT F - 51.5 HRS. 2026095-2018-00039 ONLY, PATIENT G - LESS THAN 50 HRS. (PATIENT COULD NOT GIVE ME THE EXACT TIME CATHETER WAS REMOVED, BUT WAS DEFINITELY LESS THAN 50 HRS. ADD THIS TO 2026095-2018-00040 ONLY PATIENT H - PATIENT COULD NOT TELL THE DAY OR TIME CATHETER WAS REMOVED BUT BASED ON OUR DISCUSSIONS AND THE SIZE OF THE PAIN BALL WHEN HE LEFT THE HOSPITAL, I SUSPECT IN THE RANGE OF 50 HRS. ADD THIS TO 2026095-2018-00041 ONLY. THE DOCTOR STATED ¿THE PUMPS ARE INFUSING INCORRECTLY BECAUSE AT 6 ML/HR I WOULD EXPECT SOME OF THEM TO BE CLOSER TO 67 HRS. MOST IF NOT ALL ARE INFUSING FASTER THAN THIS RATE. ADDITIONAL INFORMATION WAS RECEIVED 01-MAR-2018 FROM THE DOCTOR THAT STATED THE INCIDENT DATES WERE (B)(6) (PLACEMENT DATES

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7381744 ↗
• MalfunctionMar 29, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 400 ML, FLOW RATE: 6 ML/HR, PROCEDURE: UNKNOWN. CATHPLACE: PORT HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT PATIENTS. THIS IS THE THIRD OF EIGHT REPORTS. PATIENT A - 48 HRS. 2026095-2018-00034 ONLY, PATIENT B - 48 HRS. 2026095-2018-00035 ONLY, PATIENT C - 52.5 HRS. THIS REPORT ONLY, PATIENT D - 50.5 HRS. 2026095-2018-00037 ONLY, PATIENT E - 50.5 HRS. 2026095-2018-00038 ONLY, PATIENT F - 51.5 HRS. 2026095-2018-00039 ONLY, PATIENT G - LESS THAN 50 HRS. (PATIENT COULD NOT GIVE ME THE EXACT TIME CATHETER WAS REMOVED, BUT WAS DEFINITELY LESS THAN 50 HRS. ADD THIS TO 2026095-2018-00040 ONLY. PATIENT H - PATIENT COULD NOT TELL THE DAY OR TIME CATHETER WAS REMOVED BUT BASED ON OUR DISCUSSIONS AND THE SIZE OF THE PAIN BALL WHEN HE LEFT THE HOSPITAL, I SUSPECT IN THE RANGE OF 50 HRS. ADD THIS TO 2026095-2018-00041 ONLY. THE DOCTOR STATED ¿THE PUMPS ARE INFUSING INCORRECTLY BECAUSE AT 6 ML/HR I WOULD EXPECT SOME OF THEM TO BE CLOSER TO 67 HRS. MOST IF NOT ALL ARE INFUSING FASTER THAN THIS RATE. ADDITIONAL INFORMATION WAS RECEIVED 01-MAR-2018 FROM THE DOCTOR THAT STATED THE INCIDE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7381732 ↗
• MalfunctionMar 29, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 400 ML, FLOW RATE: 6 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: PORT. HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT PATIENTS. THIS IS THE FIFTH OF EIGHT REPORTS. PATIENT A - 48 HRS. 2026095-2018-00034 ONLY. PATIENT B - 48 HRS. 2026095-2018-00035 ONLY. PATIENT C - 52.5 HRS. 2026095-2018-00036 ONLY. PATIENT D - 50.5 HRS. 2026095-2018-00037 ONLY. PATIENT E - 50.5 HRS. 2026095-2018-00038 ONLY. PATIENT F - 51.5 HRS. 2026095-2018-00039 ONLY. PATIENT G - LESS THAN 50 HRS. (PATIENT COULD NOT GIVE ME THE EXACT TIME CATHETER WAS REMOVED, BUT WAS DEFINITELY LESS THAN 50 HRS. ADD THIS TO 2026095-2018-00040 ONLY PATIENT H - PATIENT COULD NOT TELL THE DAY OR TIME CATHETER WAS REMOVED BUT BASED ON OUR DISCUSSIONS AND THE SIZE OF THE PAIN BALL WHEN HE LEFT THE HOSPITAL, I SUSPECT IN THE RANGE OF 50 HRS. ADD THIS TO 2026095-2018-00041 ONLY. THE DOCTOR STATED ¿THE PUMPS ARE INFUSING INCORRECTLY BECAUSE AT 6 ML/HR I WOULD EXPECT SOME OF THEM TO BE CLOSER TO 67 HRS. MOST IF NOT ALL ARE INFUSING FASTER THAN THIS RATE. ADDITIONAL INFORMATION WAS RECEIVED 01-MAR-2018 FROM THE DOCTOR THAT STATED THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7381730 ↗
• MalfunctionMar 29, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 400 ML. FLOW RATE: 6 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: PORT. PATIENT A - 48 HRS. 2026095-2018-00034 ONLY, PATIENT B - 48 HRS. 2026095-2018-00035 ONLY, PATIENT C - 52.5 HRS. 2026095-2018-00036 ONLY, PATIENT D - 50.5 HRS. 2026095-2018-00037 ONLY, PATIENT E - 50.5 HRS. 2026095-2018-00038 ONLY, PATIENT F - 51.5 HRS. 2026095-2018-00039 ONLY. PATIENT G - LESS THAN 50 HRS. (PATIENT COULD NOT GIVE ME THE EXACT TIME CATHETER WAS REMOVED, BUT WAS DEFINITELY LESS THAN 50 HRS. ADD THIS TO 2026095-2018-00040 ONLY PATIENT H - PATIENT COULD NOT TELL THE DAY OR TIME CATHETER WAS REMOVED BUT BASED ON OUR DISCUSSIONS AND THE SIZE OF THE PAIN BALL WHEN HE LEFT THE HOSPITAL, I SUSPECT IN THE RANGE OF 50 HRS. ADD THIS TO 2026095-2018-00041 ONLY. THE DOCTOR STATED ¿THE PUMPS ARE INFUSING INCORRECTLY BECAUSE AT 6 ML/HR I WOULD EXPECT SOME OF THEM TO BE CLOSER TO 67 HRS. MOST IF NOT ALL ARE INFUSING FASTER THAN THIS RATE. ADDITIONAL INFORMATION WAS RECEIVED 01-MAR-2018 FROM THE DOCTOR THAT STATED THE INCIDENT DATES WERE (B)(6) FEBRUARY (PLACEMENT DATES OF CATHETERS). THERE WERE NO PATIENT CONSEQUENCES. THE PATIENTS WERE INSTRUCTED TO CARRY THE PUMPS IN THE BLACK BAG SUPPLIED AROUND THEIR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7381729 ↗
• MalfunctionMar 29, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 400 ML, FLOW RATE: 6 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: PORT. HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT PATIENTS. THIS IS THE SECOND OF EIGHT REPORTS. PATIENT A - 48 HRS. 2026095-2018-00034 ONLY, PATIENT B - 48 HRS. THIS REPORT ONLY, PATIENT C - 52.5 HRS. 2026095-2018-00036 ONLY, PATIENT D - 50.5 HRS. 2026095-2018-00037 ONLY, PATIENT E - 50.5 HRS. 2026095-2018-00038 ONLY, PATIENT F - 51.5 HRS. 2026095-2018-00039 ONLY, PATIENT G - LESS THAN 50 HRS. (PATIENT COULD NOT GIVE ME THE EXACT TIME CATHETER WAS REMOVED, BUT WAS DEFINITELY LESS THAN 50 HRS. ADD THIS TO 2026095-2018-00040 ONLY, PATIENT H - PATIENT COULD NOT TELL THE DAY OR TIME CATHETER WAS REMOVED BUT BASED ON OUR DISCUSSIONS AND THE SIZE OF THE PAIN BALL WHEN HE LEFT THE HOSPITAL, I SUSPECT IN THE RANGE OF 50 HRS. ADD THIS TO 2026095-2018-00041 ONLY. THE DOCTOR STATED ¿THE PUMPS ARE INFUSING INCORRECTLY BECAUSE AT 6 ML/HR I WOULD EXPECT SOME OF THEM TO BE CLOSER TO 67 HRS. MOST IF NOT ALL ARE INFUSING FASTER THAN THIS RATE. ADDITIONAL INFORMATION WAS RECEIVED 01-MAR-2018 FROM THE DOCTOR THAT STATED THE INCI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7381719 ↗
• MalfunctionMar 29, 2018Infusion or Flow Problem; Infusion or Flow Problem

  FILL VOLUME: 400 ML, FLOW RATE: 6 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: PORT. HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT PATIENTS. THIS IS THE FIRST OF EIGHT REPORTS. PATIENT A - 48 HRS. THIS REPORT ONLY, PATIENT B - 48 HRS. 2026095-2018-00035 ONLY, PATIENT C - 52.5 HRS. 2026095-2018-00036 ONLY, PATIENT D - 50.5 HRS. 2026095-2018-00037 ONLY, PATIENT E - 50.5 HRS. 2026095-2018-00038 ONLY, PATIENT F - 51.5 HRS. 2026095-2018-00039 ONLY, PATIENT G - LESS THAN 50 HRS. (PATIENT COULD NOT GIVE ME THE EXACT TIME CATHETER WAS REMOVED, BUT WAS DEFINITELY LESS THAN 50 HRS. ADD THIS TO 2026095-2018-00040 ONLY. PATIENT H - PATIENT COULD NOT TELL THE DAY OR TIME CATHETER WAS REMOVED BUT BASED ON OUR DISCUSSIONS AND THE SIZE OF THE PAIN BALL WHEN HE LEFT THE HOSPITAL, I SUSPECT IN THE RANGE OF 50 HRS. ADD THIS TO 2026095-2018-00041 ONLY. THE DOCTOR STATED ¿THE PUMPS ARE INFUSING INCORRECTLY BECAUSE AT 6 ML/HR I WOULD EXPECT SOME OF THEM TO BE CLOSER TO 67 HRS. MOST IF NOT ALL ARE INFUSING FASTER THAN THIS RATE. ADDITIONAL INFORMATION WAS RECEIVED 01-MAR-2018 FROM THE DOCTOR THAT STATED THE INCID

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7381713 ↗
• MalfunctionFeb 22, 2018Infusion or Flow Problem; Infusion or Flow Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2018-00008 FOR THE FIRST EVENT. REFER TO 2026095-2018-00010 FOR THE THIRD EVENT. FILL VOLUME: 400 ML; FLOW RATE: 6ML/HR; PROCEDURE: BILATERAL TOTAL KNEE AMPUTATION (TKA); CATHPLACE: BILATERAL MEDIAL THIGHS; START TIME: (B)(6) 2018 AT 1455; STOP TIME: (B)(6) 2018 AT 1120. IT WAS REPORTED THE DEVICE WAS EXPECTED TO BE 66.67-HOURS HOWEVER, THE PUMP'S THERAPY ONLY LASTED APPROXIMATELY 50-HOURS. THE PATIENT RECEIVED CONTINUOUS NERVE BLOCK AT THE BILATERAL CONTINUOUS ADDUCTOR CANAL. THERE WAS NO REPORTED INJURY. THE PATIENT CONDITION WAS NOTED TO BE "DOING FINE." THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7289891 ↗
• MalfunctionFeb 22, 2018Infusion or Flow Problem; Infusion or Flow Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2018-00008 FOR THE FIRST EVENT. REFER TO 2026095-2018-00009 FOR THE SECOND EVENT. FILL VOLUME: 400 ML, FLOW RATE: 6 ML/HR, PROCEDURE: LEFT TOTAL KNEE AMPUTATION (TKA), CATHPLACE: LEFT MEDIAL THIGH, START TIME: (B)(6) 2018 AT 1030, STOP TIME: (B)(6) 2018 AT 0700. IT WAS REPORTED THE DEVICE WAS EXPECTED TO BE 66.67-HOURS HOWEVER THE PUMP'S THERAPY ONLY LASTED APPROXIMATELY 50-HOURS. THE PATIENT RECEIVED CONTINUOUS NERVE BLOCK AT THE LEFT CONTINUOUS ADDUCTOR CANAL BLOCK. THERE WAS NO REPORTED INJURY. THE PATIENT CONDITION WAS NOTED TO BE "DOING FINE." THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7289870 ↗
• MalfunctionFeb 22, 2018Infusion or Flow Problem; Infusion or Flow Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2018-00009 FOR THE SECOND EVENT. REFER TO 2026095-2018-00010 FOR THE THIRD EVENT. FILL VOLUME: 400 ML. FLOW RATE: 6ML/HR . PROCEDURE: BILATERAL TOTAL KNEE AMPUTATION (TKA) . CATHPLACE: BILATERAL MEDIAL THIGHS. START TIME: (B)(6) 2018 AT 1455. STOP TIME: (B)(6) 2018 AT 1120. IT WAS REPORTED THE DEVICE WAS EXPECTED TO BE 66.67-HOURS HOWEVER THE PUMP'S THERAPY ONLY LASTED APPROXIMATELY 50-HOURS. THE PATIENT RECEIVED CONTINUOUS NERVE BLOCK AT THE BILATERAL CONTINUOUS ADDUCTOR CANAL. THERE WAS NO REPORTED INJURY. THE PATIENT CONDITION WAS NOTED TO BE "DOING FINE." THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7289868 ↗
• MalfunctionFeb 21, 2018Infusion or Flow Problem; Infusion or Flow Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT PATIENTS. THIS IS THE EIGHTH OF EIGHT REPORTS. REFER TO 2026095-2018-00011 FOR THE FIRST REPORT, REFER TO 2026095-2018-00012 FOR THE SECOND REPORT, REFER TO 2026095-2018-00013 FOR THE THIRD REPORT, REFER TO 2026095-2018-00014 FOR THE FOURTH REPORT, REFER TO 2026095-2018-00015 FOR THE FIFTH REPORT, REFER TO 2026095-2018-00016 FOR THE SIXTH REPORT, REFER TO 2026095-2018-00017 FOR THE SEVENTH REPORT. INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN, FILL VOLUME: 400 ML, FLOW RATE: 6 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT THE PUMP EMPTIED FASTER THAN EXPECTED. THE PUMP EMPTIED AFTER AROUND 50 HOURS INSTEAD OF THE 66.7 HOURS ANTICIPATED. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287091 ↗
• MalfunctionFeb 21, 2018Infusion or Flow Problem; Infusion or Flow Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT PATIENTS. THIS IS THE SIXTH OF EIGHT REPORTS. REFER TO 2026095-2018-00011 FOR THE FIRST REPORT, REFER TO 2026095-2018-00012 FOR THE SECOND REPORT, REFER TO 2026095-2018-00013 FOR THE THIRD REPORT, REFER TO 2026095-2018-00014 FOR THE FOURTH REPORT, REFER TO 2026095-2018-00015 FOR THE FIFTH REPORT, REFER TO 2026095-2018-00017 FOR THE SEVENTH REPORT, REFER TO 2026095-2018-00018 FOR THE EIGHTH REPORT. INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN, FILL VOLUME: 400 ML, FLOW RATE: 6 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT THE PUMP EMPTIED FASTER THAN EXPECTED. THE PUMP EMPTIED AFTER AROUND 50 HOURS INSTEAD OF THE 66.7 HOURS ANTICIPATED. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287089 ↗
• MalfunctionFeb 21, 2018Infusion or Flow Problem; Infusion or Flow Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT PATIENTS. THIS IS THE SEVENTH OF EIGHT REPORTS. REFER TO 2026095-2018-00011 FOR THE FIRST REPORT, REFER TO 2026095-2018-00012 FOR THE SECOND REPORT, REFER TO 2026095-2018-00013 FOR THE THIRD REPORT, REFER TO 2026095-2018-00014 FOR THE FOURTH REPORT, REFER TO 2026095-2018-00015 FOR THE FIFTH REPORT, REFER TO 2026095-2018-00016 FOR THE SIXTH REPORT, REFER TO 2026095-2018-00018 FOR THE EIGHTH REPORT. INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN, FILL VOLUME: 400 ML, FLOW RATE: 6ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT THE PUMP EMPTIED FASTER THAN EXPECTED. THE PUMP EMPTIED AFTER AROUND 50 HOURS INSTEAD OF THE 66.7 HOURS ANTICIPATED. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287068 ↗
• MalfunctionFeb 21, 2018Infusion or Flow Problem; Infusion or Flow Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT PATIENTS. THIS IS THE FIFTH OF EIGHT REPORTS. REFER TO 2026095-2018-00011 FOR THE FIRST REPORT, REFER TO 2026095-2018-00012 FOR THE SECOND REPORT, REFER TO 2026095-2018-00013 FOR THE THIRD REPORT, REFER TO 2026095-2018-00014 FOR THE FOURTH REPORT, REFER TO 2026095-2018-00016 FOR THE SIXTH REPORT, REFER TO 2026095-2018-00017 FOR THE SEVENTH REPORT, REFER TO 2026095-2018-00018 FOR THE EIGHTH REPORT. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. FILL VOLUME: 400 ML. FLOW RATE: 6ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THAT THE PUMP EMPTIED FASTER THAN EXPECTED. THE PUMP EMPTIED AFTER AROUND 50 HOURS INSTEAD OF THE 66.7 HOURS ANTICIPATED. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287067 ↗
• MalfunctionFeb 21, 2018Infusion or Flow Problem; Infusion or Flow Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT PATIENTS. THIS IS THE FOURTH OF EIGHT REPORTS. REFER TO 2026095-2018-00011 FOR THE FIRST REPORT, REFER TO 2026095-2018-00012 FOR THE SECOND REPORT, REFER TO 2026095-2018-00013 FOR THE THIRD REPORT, REFER TO 2026095-2018-00015 FOR THE FIFTH REPORT, REFER TO 2026095-2018-00016 FOR THE SIXTH REPORT, REFER TO 2026095-2018-00017 FOR THE SEVENTH REPORT, REFER TO 2026095-2018-00018 FOR THE EIGHTH REPORT. INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN, FILL VOLUME: 400 ML, FLOW RATE: 6 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT THE PUMP EMPTIED FASTER THAN EXPECTED. THE PUMP EMPTIED AFTER AROUND 50 HOURS INSTEAD OF THE 66.7 HOURS ANTICIPATED. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287061 ↗
• MalfunctionFeb 21, 2018Infusion or Flow Problem; Infusion or Flow Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT PATIENTS. THIS IS THE SECOND OF EIGHT REPORTS. REFER TO 2026095-2018-00011 FOR THE FIRST REPORT. REFER TO 2026095-2018-00013 FOR THE THIRD REPORT. REFER TO 2026095-2018-00014 FOR THE FOURTH REPORT. REFER TO 2026095-2018-00015 FOR THE FIFTH REPORT. REFER TO 2026095-2018-00016 FOR THE SIXTH REPORT. REFER TO 2026095-2018-00017 FOR THE SEVENTH REPORT. REFER TO 2026095-2018-00018 FOR THE EIGHTH REPORT. INFUSION START TIME: (B)(6) 2018 1:55PM. INFUSION STOP TIME: (B)(6) 2018 4:52PM. FILL VOLUME: 400 ML. FLOW RATE: 6ML/HR. PROCEDURE: LEFT TOTAL KNEE ARTHROPLASTY. CATHPLACE: ADDUCTOR CANAL BLOCK (L). IT WAS REPORTED THAT THE PUMP EMPTIED FASTER THAN EXPECTED. THE PUMP EMPTIED AFTER AROUND 50 HOURS INSTEAD OF THE 66.7 HOURS ANTICIPATED. THE PUMP WAS FILLED UNDER ROOM TEMPERATURE CONDITIONS. THERE WERE NO INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287059 ↗
• MalfunctionFeb 21, 2018Infusion or Flow Problem; Infusion or Flow Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT PATIENTS. THIS IS THE THIRD OF EIGHT REPORTS. REFER TO 2026095-2018-00011 FOR THE FIRST REPORT, REFER TO 2026095-2018-00012 FOR THE SECOND REPORT, REFER TO 2026095-2018-00014 FOR THE FOURTH REPORT , REFER TO 2026095-2018-00015 FOR THE FIFTH REPORT, REFER TO 2026095-2018-00016 FOR THE SIXTH REPORT, REFER TO 2026095-2018-00017 FOR THE SEVENTH REPORT, REFER TO 2026095-2018-00018 FOR THE EIGHTH REPORT. INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN, FILL VOLUME: 400ML, FLOW RATE: 6ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THAT THE PUMP EMPTIED FASTER THAN EXPECTED. THE PUMP EMPTIED AFTER AROUND 50 HOURS INSTEAD OF THE 66.7 HOURS ANTICIPATED. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287058 ↗
• MalfunctionFeb 21, 2018Infusion or Flow Problem; Infusion or Flow Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING EIGHT DIFFERENT PATIENTS. THIS IS THE FIRST OF EIGHT REPORTS. REFER TO 2026095-2018-00012 FOR THE SECOND REPORT, REFER TO 2026095-2018-00013 FOR THE THIRD REPORT, REFER TO 2026095-2018-00014 FOR THE FOURTH REPORT, REFER TO 2026095-2018-00015 FOR THE FIFTH REPORT, REFER TO 2026095-2018-00016 FOR THE SIXTH REPORT, REFER TO 2026095-2018-00017 FOR THE SEVENTH REPORT, REFER TO 2026095-2018-00018 FOR THE EIGHTH REPORT. INFUSION START TIME: (B)(6) 2018 10:50 AM, INFUSION STOP TIME: (B)(6) 2018 12:00 PM, FILL VOLUME: 400 ML, FLOW RATE: 6 ML/HR, PROCEDURE: RIGHT TOTAL KNEE ARTHROPLASTY, CATHPLACE: ADDUCTOR CANAL BLOCK (R). IT WAS REPORTED THAT THE PUMP EMPTIED FASTER THAN EXPECTED. THE PUMP EMPTIED AFTER AROUND 50 HOURS INSTEAD OF THE 66.7 HOURS ANTICIPATED. THE PUMP WAS FILLED UNDER ROOM TEMPERATURE CONDITIONS. THERE WERE NO INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7287052 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063530. One submission often covers many models, so check the product and lot details in each record.

• Z-2860-2011 · Apr 15, 2011 · Terminated
  I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for p
• Z-2133-2008 · Feb 14, 2008 · Terminated
  On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narc
• Z-1869-2008 · Feb 12, 2008 · Terminated
  ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anest