DOSI-FUSER L25915-250D2-USARecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08436020760082), received between Nov 20, 2017 and Nov 22, 2018 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (16 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, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, 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 ↗
• 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 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 ↗
• MalfunctionSep 14, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IN 5-FU MEDICATION SCHEDULED FOR 46 HOURS, INFUSION TIME FINISHED MUCH EARLIER THAN EXPECTED. PATIENT WAS SCHEDULED AT 15.10 (APPROX.) FOR 5-FU TAKEDOWN. PATIENT CALLED AND STATED THAT HER INFUSOR WAS FINISHED AT 08.30. AT 10.10, A NURSE ARRIVED AND INSPECTED THE INFUSOR. AS PER NURSE OBSERVATION, THE INFUSOR WAS COMPLETED. THE CHEMO INFUSION FINISHED FOR ABOUT 6 ½ HOURS EARLIER THAN THE EXPECTED TIME (THE ACCURACY OF THE INFUSION TIME IS +/- 10%). IN ADDITION, PATIENT STATED THAT "THIS HAPPENS ALL THE TIME, I AM NOT NEW TO THIS DEVICE AND IT'S ALWAYS EARLY".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877857 ↗
• MalfunctionSep 14, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IN 5-FU MEDICATION SCHEDULED FOR 46 HOURS, INFUSION TIME FINISHED MUCH EARLIER THAN EXPECTED. PATIENT RECEIVED 5-FU 3200MG AND IT WAS EXPECTED TO FINISH AROUND NOON. HOWEVER, THE INFUSION FINISHED 10 HOURS EARLY (THE ACCURACY OF THE INFUSION TIME IS +/- 10%). PATIENT EXPERIENCED ADVERSE EFFECTS OF FACE AND TONGUE SWELLING THAT LASTED 2 DAYS, BUT DENIED NAUSEA / VOMITING / DIARRHEA.

  Patient problems: Swelling

  MAUDE report 7877807 ↗
• MalfunctionSep 14, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IN 5-FU MEDICATION SCHEDULED FOR 46 HOURS, INFUSION TIME FINISHED MUCH EARLIER THAN EXPECTED. PATIENT RECEIVED A TOTAL VOLUME OF 221 ML CHEMO INFUSION, WHICH CONSISTS OF 51 ML OF 5-FU 2550MG AND 170 ML OF NORMAL SALINE. PATIENT REPORTED THAT HIS INFUSION FINISHED >2 HOURS EARLIER THAN THE SCHEDULED TIME (THE ACCURACY OF THE INFUSION TIME IS +/- 10%).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877796 ↗
• MalfunctionSep 14, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IN 5-FU MEDICATION SCHEDULED FOR 46 HOURS, INFUSION TIME FINISHED MUCH EARLIER THAN EXPECTED. PATIENT RECEIVED A TOTAL VOLUME OF 221 ML CHEMO INFUSION, WHICH CONSISTS OF 72 ML OF 5-FU 3800MG AND 149 ML OF NORMAL SALINE. PATIENT REPORTED THAT HER INFUSION FINISHED 7 HOURS EARLIER THAN THE EXPECTED TIME (THE ACCURACY OF THE INFUSION TIME IS +/- 10%).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877731 ↗
• MalfunctionSep 14, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IN 5-FU MEDICATION SCHEDULED FOR 46 HOURS, INFUSION TIME FINISHED MUCH EARLIER THAN EXPECTED. IN THIS CASE PATIENT EXPERIENCED THIS PROBLEM TWICE. PATIENT RECEIVED A TOTAL VOLUME OF 221 ML CHEMO INFUSION, WHICH CONSISTS OF 76 ML OF 5-FU 3800 MG AND 145 ML OF NORMAL SALINE. PATIENT REPORTED THAT HER DOSI-FUSER WAS EMPTY 5 HOURS EARLIER THAN THE SCHEDULED TIME. LATER, SHE RECEIVED AGAIN 76 ML OF 5-FU 3800 MG AND 145 ML OF NORMAL SALINE. SHE REPORTED THAT IN THIS CASE THE DOSI-FUSER WAS EMPTY 7 HOURS EARLIER THAN THE SCHEDULED TIME (THE ACCURACY OF THE INFUSION TIME IS +/- 10%).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877716 ↗
• MalfunctionSep 14, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IN 5-FU MEDICATION SCHEDULED FOR 46 HOURS, INFUSION TIME FINISHED MUCH EARLIER THAN EXPECTED. PATIENT RECEIVED A TOTAL VOLUME OF 221 ML CHEMO INFUSION WHICH CONSISTS OF 5-FU 2750 (55 ML) AND 166 ML OF NORMAL SALINE. PATIENT REPORTED THAT HER INFUSION FINISHED 5 HOURS EARLIER THAN THE EXPECTED TIME (THE ACCURACY OF THE INFUSION TIME IS +/- 10%).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877633 ↗
• MalfunctionAug 6, 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 7752552 ↗
• MalfunctionMay 31, 2018Burst Container or Vessel; Burst Container or Vessel

  RUPTURE OF ELASTOMERIC DRUG RESERVOIR PRIOR TO USE (DOSI-FUSER).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7556674 ↗
• MalfunctionMay 29, 2018Fluid/Blood Leak; Fluid/Blood Leak

  FLUORURACIL ADMINISTERED IV VIA LEVENTON 4.7ML/HR 250ML PORTABLE ELASTOMERIC INFUSOR OVER A 46 HR PERIOD. AT END OF INFUSION, PT PRESENTED AT CLINIC WITH WET INFUSER BAG AND CLOTHING. THE INFUSER SYSTEM HAD APPARENTLY LEAKED. CRYSTALS APPEARED WHERE DRUG LEAK HAD EVAPORATED. LARGEST AMOUNT APPEARED AT THE SEAM ON "CAPILLARY ELEMENT" (A. K. A. "RESTRICTER ELEMENT").

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7548840 ↗
• MalfunctionMay 29, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  PATIENT ARRIVED TO INFUSION WITH CONCERN THAT EIS PUMP IS INFUSING TOO FAST. IT APPEARS THE PUMP IS HALFWAY COMPLETED AT 18 HOURS. IT APPEARS THE MEDICATION MAY BE COMPLETED 10 HOURS AHEAD OF TIME. PATIENT WAS ADVISED TO REMOVE THE SENSOR AND LET IT HANG FREELY AND TO CALL THE PROVIDER WITH ANY CONCERNS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7548294 ↗
• MalfunctionMay 29, 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. INTERNAL INVESTIGATION CONFIRMED THAT THE MEDICATIONS FOR INFUSION WERE PREPARED AND PACKAGED CORRECTLY AND THAT THE DOSI-FUSERS WERE PREPARED CORRECTLY. INTERNAL INVESTIGATION ALSO CONFIRMED THAT NURSING STAFF APPLIED THE DOSI-FUSERS TO THE PATIENTS CORRECTLY AND WITH THE APPROPRIATE TECHNIQUE. NONE OF THE 6 PATIENTS EXPERIENCED ANY HARM, ALTHOUGH THE POTENTIAL FOR HARM EXISTS AND HAS BEEN DEEMED SIGNIFICANT ENOUGH TO REMOVE THE DOSI-

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7548195 ↗
• MalfunctionMay 28, 2018Fluid/Blood Leak; Fluid/Blood Leak

  PT HAD LEVENTON PUMP ATTACHED AND RETURNED 46 HOURS LATER FOR PUMP DETACHMENT. IT WAS NOTED TO HAVE ABOUT 1-2 ML OF LOOSE LIQUID IN THE PUMP. NO OBVIOUS SIGNS OF LEAKING FROM THE PUMP AND BALLOON WAS DEFLATED INDICATING PUMP WAS EMPTY. PT DENIED ANY PROBLEMS WITH LEAKING FROM THE PUMP AND DID NOT NOTICE ANY LIQUID IN THE PUMP WHILE AT HOME AND STATES IT MUST HAVE HAPPENED THE MORNING OF SCHEDULED DETACHMENT. PUMP WAS DISCONNECTED AND STORED AND IS WAITING TO BE SENT TO MANUFACTURER FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7547871 ↗
• MalfunctionMay 25, 2018Fluid/Blood Leak; Fluid/Blood Leak

  DOSI-FUSER ELASTOMERIC AMBULATORY PUMP LEAKED DURING 46 HR INFUSION AND WAS REPORTED TODAY THIS MORNING, THE DAY IT WAS TO BE DISCONNECTED. A SMALL PORTION OF FLUID (FLUOROURACIL AND NORMAL SALINE) WAS DETECTED ON PATIENT'S NIGHTSHIRT THIS MORNING AT THE HOME. IT APPEARED THE LEAK WAS ASSOCIATED WITH THE SEAM AROUND THE "SLO-FLOW" CAPILLARY ELEMENT. WHITE CRYSTAL ACCUMULATION AROUND THE SEAM OF THE CAPILLARY ELEMENT WAS CLEARLY VISIBLE BY RN AND PHARMACY STAFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7543936 ↗
• MalfunctionMay 23, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IN 5-FU MEDICATION SCHEDULED FOR 46 HOURS, PATIENTS REPORTED THAT INFUSION TIME FINISHED 2-10 HOURS EARLIER. FIVE PATIENTS EXPERIENCED THE SAME PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7537070 ↗
• MalfunctionMay 23, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  PATIENT WAS SCHEDULED ON (B)(6) 2018 AT 15.10 (APPROXIMATION) FOR 5FU TAKEDOWN. PATIENT CALLED AND STATED THAT HER INFUSOR WAS FINISHED AT 08.30. AT 10.10, A NURSE ARRIVED AND INSPECTED THE INFUSOR. AS PER NURSE OBSERVATION, THE INFUSOR WAS INDEED COMPLETE. BASED ON THE DIFFERENCE OF THE SCHEDULED TIME AND PATIENT'S CALLED, THE CHEMO INFUSION FINISHED FOR ABOUT 6 ½ HOURS EARLIER THAN THE EXPECTED TIME. IN ADDITION, PATIENT STATED THAT "THIS HAPPENS ALL THE TIME, I'M NOT NEW TO THIS DEVICE AND IT'S ALWAYS EARLY".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7536200 ↗