DOSI-FUSERRecalls & reported problems across all models

We found 5 models of DOSI-FUSER by Epic International(Thailand) Company Limited in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between Oct 23, 2017 and Nov 22, 2018 — classified as 2 injuries, 41 malfunctions.

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

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported DOSI-FUSER problems

DOSI-FUSER models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DOSI-FUSER L25915-250D2-USA

  Pump, Infusion, Elastomeric
  27 reports
• DOSI-FUSER L25915-250D5-USA

  Pump, Infusion, Elastomeric
  6 reports
• DOSI-FUSER L25915-150D2-USA

  Pump, Infusion, Elastomeric
  5 reports
• DOSI-FUSER L25915-100D2-USA

  Pump, Infusion, Elastomeric
  4 reports
• DOSI-FUSER L25915-250D1-USA

  Pump, Infusion, Elastomeric
  1 report

Recent DOSI-FUSER adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2018Infusion or Flow Problem; Infusion or Flow Problem

  GRIFOLS DOSI-FUSER 46 HOUR PUMP FAILED TO INFUSE MEDICATION IN REQUIRED TIME. CONTACT 5-FU.

  Patient problems: Missed Dose

  MAUDE report 8098894 ↗
• MalfunctionOct 5, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  A WHITE POWDERY FILM WAS IDENTIFIED ON ALL THE PUMPS OPENED FOR 2 BOXES OF DOSI-FUSER 250D2 LOT 181171L. ALL CASES/PUMPS WERE SEQUESTERED AND RETURNED TO MANUFACTURER. IN ADDITION, THAT SAME WHITE SUBSTANCE WAS IDENTIFIED ON 2 DOSI-FUSER 250D1 PUMPS, LOT 181087L, THAT WERE RETURNED TO THE MANUFACTURER AS WELL. THIS WHITE POWDER IS OBSERVED BOTH IN THE INSIDE AND THE OUTSIDE OF THE TRANSPARENT CONTAINER.

  Patient problems: No Patient Involvement

  MAUDE report 7937878 ↗
• MalfunctionOct 5, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  A WHITE POWDERY FILM WAS IDENTIFIED ON ALL THE PUMPS OPENED FOR 2 BOXES OF DOSI-FUSER 250D2 LOT 181171L. ALL CASES/PUMPS WERE SEQUESTERED AND RETURNED TO MANUFACTURER. IN ADDITION, THAT SAME WHITE SUBSTANCE WAS IDENTIFIED ON 2 DOSI-FUSER 250D1 PUMPS, LOT 181087L, THAT WERE RETURNED TO THE MANUFACTURER AS WELL. THIS WHITE POWDER IS OBSERVED BOTH IN THE INSIDE AND THE OUTSIDE OF THE TRANSPARENT CONTAINER.

  Patient problems: No Patient Involvement

  MAUDE report 7937876 ↗
• MalfunctionSep 24, 2018Fluid/Blood Leak; Fluid/Blood Leak

  TWO INCIDENTS WERE REPORTED REGARDING 5-FU USING DOSI-FUSER. IN BOTH CASES; THE CHEMO WAS FOUND TO BE LEAKING THROUGH THE DOSI-FUSER. THESE INCIDENCES DID NOT REACH THE DESIGNATED PATIENTS AS THEY WERE DISCOVERED BY THE INFUSION NURSE AT THE CLINIC PRIOR TO ADMINISTRATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7901597 ↗
• MalfunctionSep 24, 2018Fluid/Blood Leak; Fluid/Blood Leak

  TWO INCIDENTS WERE REPORTED REGARDING 5-FU USING DOSI-FUSER. IN BOTH CASES; THE CHEMO WAS FOUND TO BE LEAKING THROUGH THE DOSI-FUSER. THESE INCIDENCES DID NOT REACH THE DESIGNATED PATIENTS AS THEY WERE DISCOVERED BY THE INFUSION NURSE AT THE CLINIC PRIOR TO ADMINISTRATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7901594 ↗
• MalfunctionSep 24, 2018Fluid/Blood Leak; Fluid/Blood Leak

  USING LEVENTON PORTABLE DOSI-FUSER LV 5. 2 2. 1 ML FOR OUTPATIENT CHEMO PATIENTS. HAVE HAD 4 INCIDENTS OF THE CHEMO LEAKING AT THE CAPILLARY SENSOR (TAPED TO THE SKIN OF THE PATIENT), HAS LEAKED AND CAUSED THE CHEMO TO CRYSTALIZE OUTSIDE OF THE PATIENT'S BODY. CONTACTED THE DISTRIBUTOR, PULLED AND RETURNED ALL CATALOG OF PRODUCT CODE #250D5 WITH LOT #170101L (22 EACH) FOR QA BY MANUFACTURER. PORTABLE CHEMO PUMP USED IN HEMATOLOGY ONCOLOGY PRACTICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7901273 ↗
• MalfunctionSep 24, 2018Fluid/Blood Leak; Fluid/Blood Leak

  USING LEVENTON PORTABLE DOSI-FUSER LV 5. 2 2. 1 ML FOR OUTPATIENT CHEMO PATIENTS. HAVE HAD 4 INCIDENTS OF THE CHEMO LEAKING AT THE CAPILLARY SENSOR (TAPED TO THE SKIN OF THE PATIENT), HAS LEAKED AND CAUSED THE CHEMO TO CRYSTALIZE OUTSIDE OF THE PATIENT'S BODY. CONTACTED THE DISTRIBUTOR, PULLED AND RETURNED ALL CATALOG OF PRODUCT CODE #250D5 WITH LOT #170101L (22 EACH) FOR QA BY MANUFACTURER. PORTABLE CHEMO PUMP USED IN HEMATOLOGY ONCOLOGY PRACTICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7901271 ↗
• MalfunctionSep 24, 2018Fluid/Blood Leak; Fluid/Blood Leak

  USING LEVENTON PORTABLE DOSI-FUSER LV 5. 2 2. 1 ML FOR OUTPATIENT CHEMO PATIENTS. HAVE HAD 4 INCIDENTS OF THE CHEMO LEAKING AT THE CAPILLARY SENSOR (TAPED TO THE SKIN OF THE PATIENT), HAS LEAKED AND CAUSED THE CHEMO TO CRYSTALIZE OUTSIDE OF THE PATIENT'S BODY. CONTACTED THE DISTRIBUTOR, PULLED AND RETURNED ALL CATALOG OF PRODUCT CODE #250D5 WITH LOT #170101L (22 EACH) FOR QA BY MANUFACTURER. PORTABLE CHEMO PUMP USED IN HEMATOLOGY ONCOLOGY PRACTICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7901270 ↗
• MalfunctionSep 24, 2018Fluid/Blood Leak; Fluid/Blood Leak

  USING LEVENTON PORTABLE DOSI-FUSER LV 5. 2 2. 1 ML FOR OUTPATIENT CHEMO PATIENTS. HAVE HAD 4 INCIDENTS OF THE CHEMO LEAKING AT THE CAPILLARY SENSOR (TAPED TO THE SKIN OF THE PATIENT), HAS LEAKED AND CAUSED THE CHEMO TO CRYSTALIZE OUTSIDE OF THE PATIENT'S BODY. CONTACTED THE DISTRIBUTOR, PULLED AND RETURNED ALL CATALOG OF PRODUCT CODE #250D5 WITH LOT #170101L (22 EACH) FOR QA BY MANUFACTURER. PORTABLE CHEMO PUMP USED IN HEMATOLOGY ONCOLOGY PRACTICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7901269 ↗
• MalfunctionSep 21, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  DOSI-FUSER (GRIFOLS) IS AN ELASTOMERIC INFUSER THAT WAS IMPLEMENTED AS A REPLACEMENT FOR THE CADD PRISZM PUMPS. CURRENTLY, WE HAVE APPROXIMATELY 5-10 PATIENTS PER WEEK THAT IS USING DOSI-FUSER. THE TYPICAL REGIMEN CALLS FOR THE MEDICATION TO BE GIVEN OVER 46 HOURS. THERE IS A STANDARD DEVIATION OF PLUS/MINUS 10 PERCENT VARIABILITY FOR INFUSION TIME. OVER A TWO-WEEK PERIOD, 6 OUT OF 14 PATIENTS EXPERIENCED EARLY COMPLETION OF THEIR INFUSIONS WITH THE DOSI-FUSER, WITH COMPLETION TIMES RANGING FROM 5 HOURS TO 9.5 HOURS AHEAD OF SCHEDULE. WITH A PLANNED INFUSION TIME OF 46 HOURS, A STANDARD DEVIATION OF PLUS/MINUS 10 PERCENT WOULD ALLOW NORMAL VARIATION WITHIN 4.6 HOURS. EARLY COMPLETION TIMES OF 5 - 9.5 HOURS AHEAD OF PLAN EXCEED THE STANDARD DEVIATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7896979 ↗
• MalfunctionSep 21, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  DOSI-FUSER (GRIFOLS) IS AN ELASTOMERIC INFUSER THAT WAS IMPLEMENTED AS A REPLACEMENT FOR THE CADD PRISZM PUMPS. CURRENTLY, WE HAVE APPROXIMATELY 5-10 PATIENTS PER WEEK THAT IS USING DOSI-FUSER. THE TYPICAL REGIMEN CALLS FOR THE MEDICATION TO BE GIVEN OVER 46 HOURS. THERE IS A STANDARD DEVIATION OF PLUS/MINUS 10 PERCENT VARIABILITY FOR INFUSION TIME. OVER A TWO-WEEK PERIOD, 6 OUT OF 14 PATIENTS EXPERIENCED EARLY COMPLETION OF THEIR INFUSIONS WITH THE DOSI-FUSER, WITH COMPLETION TIMES RANGING FROM 5 HOURS TO 9.5 HOURS AHEAD OF SCHEDULE. WITH A PLANNED INFUSION TIME OF 46 HOURS, A STANDARD DEVIATION OF PLUS/MINUS 10 PERCENT WOULD ALLOW NORMAL VARIATION WITHIN 4.6 HOURS. EARLY COMPLETION TIMES OF 5 - 9.5 HOURS AHEAD OF PLAN EXCEED THE STANDARD DEVIATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7896978 ↗
• MalfunctionSep 21, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  DOSI-FUSER (GRIFOLS) IS AN ELASTOMERIC INFUSER THAT WAS IMPLEMENTED AS A REPLACEMENT FOR THE CADD PRISZM PUMPS. CURRENTLY, WE HAVE APPROXIMATELY 5-10 PATIENTS PER WEEK THAT IS USING DOSI-FUSER. THE TYPICAL REGIMEN CALLS FOR THE MEDICATION TO BE GIVEN OVER 46 HOURS. THERE IS A STANDARD DEVIATION OF PLUS/MINUS 10 PERCENT VARIABILITY FOR INFUSION TIME. OVER A TWO-WEEK PERIOD, 6 OUT OF 14 PATIENTS EXPERIENCED EARLY COMPLETION OF THEIR INFUSIONS WITH THE DOSI-FUSER, WITH COMPLETION TIMES RANGING FROM 5 HOURS TO 9.5 HOURS AHEAD OF SCHEDULE. WITH A PLANNED INFUSION TIME OF 46 HOURS, A STANDARD DEVIATION OF PLUS/MINUS 10 PERCENT WOULD ALLOW NORMAL VARIATION WITHIN 4.6 HOURS. EARLY COMPLETION TIMES OF 5 - 9.5 HOURS AHEAD OF PLAN EXCEED THE STANDARD DEVIATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7896977 ↗
• MalfunctionSep 21, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  DOSI-FUSER (GRIFOLS) IS AN ELASTOMERIC INFUSER THAT WAS IMPLEMENTED AS A REPLACEMENT FOR THE CADD PRISZM PUMPS. CURRENTLY, WE HAVE APPROXIMATELY 5-10 PATIENTS PER WEEK THAT IS USING DOSI-FUSER. THE TYPICAL REGIMEN CALLS FOR THE MEDICATION TO BE GIVEN OVER 46 HOURS. THERE IS A STANDARD DEVIATION OF PLUS/MINUS 10 PERCENT VARIABILITY FOR INFUSION TIME. OVER A TWO-WEEK PERIOD, 6 OUT OF 14 PATIENTS EXPERIENCED EARLY COMPLETION OF THEIR INFUSIONS WITH THE DOSI-FUSER, WITH COMPLETION TIMES RANGING FROM 5 HOURS TO 9.5 HOURS AHEAD OF SCHEDULE. WITH A PLANNED INFUSION TIME OF 46 HOURS, A STANDARD DEVIATION OF PLUS/MINUS 10 PERCENT WOULD ALLOW NORMAL VARIATION WITHIN 4.6 HOURS. EARLY COMPLETION TIMES OF 5 - 9.5 HOURS AHEAD OF PLAN EXCEED THE STANDARD DEVIATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7896976 ↗
• MalfunctionSep 21, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  DOSI-FUSER (GRIFOLS) IS AN ELASTOMERIC INFUSER THAT WAS IMPLEMENTED AS A REPLACEMENT FOR THE CADD PRISZM PUMPS. CURRENTLY, WE HAVE APPROXIMATELY 5-10 PATIENTS PER WEEK THAT IS USING DOSI-FUSER. THE TYPICAL REGIMEN CALLS FOR THE MEDICATION TO BE GIVEN OVER 46 HOURS. THERE IS A STANDARD DEVIATION OF PLUS/MINUS 10 PERCENT VARIABILITY FOR INFUSION TIME. OVER A TWO-WEEK PERIOD, 6 OUT OF 14 PATIENTS EXPERIENCED EARLY COMPLETION OF THEIR INFUSIONS WITH THE DOSI-FUSER, WITH COMPLETION TIMES RANGING FROM 5 HOURS TO 9.5 HOURS AHEAD OF SCHEDULE. WITH A PLANNED INFUSION TIME OF 46 HOURS, A STANDARD DEVIATION OF PLUS/MINUS 10 PERCENT WOULD ALLOW NORMAL VARIATION WITHIN 4.6 HOURS. EARLY COMPLETION TIMES OF 5 - 9.5 HOURS AHEAD OF PLAN EXCEED THE STANDARD DEVIATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7896974 ↗
• MalfunctionSep 21, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  DOSI-FUSER (GRIFOLS) IS AN ELASTOMERIC INFUSER THAT WAS IMPLEMENTED AS A REPLACEMENT FOR THE CADD PRISZM PUMPS. CURRENTLY, WE HAVE APPROXIMATELY 5-10 PATIENTS PER WEEK THAT IS USING DOSI-FUSER. THE TYPICAL REGIMEN CALLS FOR THE MEDICATION TO BE GIVEN OVER 46 HOURS. THERE IS A STANDARD DEVIATION OF PLUS/MINUS 10 PERCENT VARIABILITY FOR INFUSION TIME. OVER A TWO-WEEK PERIOD, 6 OUT OF 14 PATIENTS EXPERIENCED EARLY COMPLETION OF THEIR INFUSIONS WITH THE DOSI-FUSER, WITH COMPLETION TIMES RANGING FROM 5 HOURS TO 9.5 HOURS AHEAD OF SCHEDULE. WITH A PLANNED INFUSION TIME OF 46 HOURS, A STANDARD DEVIATION OF PLUS/MINUS 10 PERCENT WOULD ALLOW NORMAL VARIATION WITHIN 4.6 HOURS. EARLY COMPLETION TIMES OF 5 - 9.5 HOURS AHEAD OF PLAN EXCEED THE STANDARD DEVIATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7896973 ↗

Other Epic International(Thailand) Company Limited products

• SMARTeZ Pump5 models · 45 reports