Plum 360 30010Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI M3353001004051), received between Feb 22, 2017 and Feb 24, 2026 — classified as 3 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (24 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Air/Gas in Device

  AN EVENT INVOLVING A PLUM 360 REPORTED THAT THE INTRAVENOUS (IV) PUMP WAS ALARMING FOR PROXIMAL AIR WHILE INFUSING NOREPINEPHRINE. BACK PRIMING WAS DONE, AND NO AIR BUBBLES WERE SEEN IN THE SYRINGE. HOWEVER, AFTER RESTARTING THE PUMP, THE ALARM FOR AIR PERSISTED, AND THE PROCESS WAS REPEATED MULTIPLE TIMES WITH NO AIR DETECTED EACH TIME. DUE TO THE INTERRUPTIONS IN THE NOREPINEPHRINE INFUSION, THE PATIENT'S BLOOD PRESSURE DROPPED TO 72/54, THEN 59/51, REQUIRING A REGISTERED NURSE (RN) TO ADMINISTER 200 MCG OF IV PHENYLEPHRINE. THE IV LINE AND PUMP WERE REPLACED, AND A NEW INFUSION WAS STARTED WITH NO FURTHER ISSUES. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24438715 ↗
• MalfunctionFeb 5, 2025Unexpected Shutdown; Unexpected Shutdown

  A MEDWATCH WAS RECEIVED REGARDING AN UNSPECIFIED PLUM 360 THAT EXPERIENCED UNEXPECTED SHUTDOWN. IT WAS STATED THAT THE BATTERIES IN THE PUMPS ARE THE CSB BATTERIES. "ONE PUMP HAS FAILED WHILE BEING USED ON PATIENT WITH THE BATTERY ISSUE." THE PUMP HAS BEEN SEQUESTERED. THUS, THERE WAS PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM AND UNKNOWN DELAY IN THERAPY REPORTED. FULL EVENT DESCRIPTION: ICUMEDICAL 360 PLUM IV PUMPS. WE PURCHASE 863 IV PUMPS TWO MONTHS AGO AND SINCE THE GO LIVE DATE WE HAVE HAD 165 HAVE COME TO BIOMED WITH A REPLACED BATTERY ALARM, ICU FSE. ERROR CODE "N56 REPLACE BATTERY" ICU MEDICAL HAS REPLACED 167 BATTERIES BUT TWO OF THE PUMPS CAME BACK WITH THE SAME PROBLEM. A LITTLE OVER 20% OF OUR PUMPS FAILED SINCE FIRST PURCHASE. ICU MEDICAL ASSURED US BEFORE OUR GO LIVE DATE THAT BATTERY ISSUE WAS FIXED. THE FIRST NOTIFICATION OF PUMP BATTERIES BEING DEAD WHILE PLUGGED IN WAS ON (B)(6) 2024 AND WAS IMMEDIATELY ESCALATED TO ICU MEDICAL. THE BATTERIES IN THE PUMPS ARE THE CSB BATTERIES. ONE PUMP HAS FAILED WHILE BEING USED ON PATIENT WITH THE BATTERY ISSUE. THE PUMP HAS BEEN SEQUESTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21317504 ↗
• MalfunctionSep 30, 2024Air/Gas in Device; Air/Gas in Device

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND WAS IN REGARD TO A GENERAL COMPLAINT REGARDING AIR BUBBLE ISSUES ON ICU MEDICAL INFUSION PUMPS, SPECIFICALLY PLUM 360. THE CUSTOMER REPORTED THAT THE PUMP HAD AIR IN THE LINE BUT CONTINUED TO INFUSE DURING USE ON A PATIENT. THE CUSTOMER FURTHER STATED THAT IT SEEMS TO ONLY OCCUR WHEN THE NURSES ARE DOING THE IVIG INFUSIONS WHERE MICROBUBBLES APPEAR PAST THE PLUM CASSETTE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE AIR SEEMED TO BE MORE OF A FOAM THAT DEVELOPED WITH A SPECIFIC MEDICATION AND THERE WAS NOT TRULY A LARGE AIR BUBBLE THAT DEVELOPED IN THE LINE. SO, THE PUMP CONTINUED TO INFUSE, BUT THAT IS BECAUSE THE LIQUID APPEARED TO BE MORE OF A FOAM AS IT WAS INFUSED INTO THE PATIENT. THERE WAS PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20339945 ↗
• MalfunctionJul 27, 2022Protective Measures Problem

  WHILE INFUSING IV PUMP ALARMED STATING INFUSION DOOR OPENED, PLEASE CLOSE. WHEN DOOR WAS OPENED AND CLOSED AGAIN PUMP THEN WAS FROZEN.

  Patient problems: Insufficient Information

  MAUDE report 15111681 ↗
• MalfunctionOct 6, 2020Inaccurate Delivery; Inaccurate Delivery

  THE EVENT OCCURRED ON AN UNKNOWN DATE AND INVOLVED A PLUM 360 PUMP WHERE AN INFUSION OF METHOTREXATE COMPLETED 1.5 HOURS EARLIER THAN EXPECTED. THERE IS NO REPORT OF ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10638564 ↗
• MalfunctionSep 28, 2018Premature Discharge of Battery; Premature Discharge of Battery

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN 2018. THE EVENT INVOLVED A CUSTOMER ALLEGATION THE DEVICE TURNS OFF THE MOMENT IT IS UNPLUGGED, DOES NOT HOLD A CHARGE. A REVIEW OF THE EVENT LOG SHOWED SEVERAL RECENT ENTRIES FOR N56 REPLACE BATTERY AND N252 DEPLETED BATTERY ALARMS. DURING TESTING AND INVESTIGATION, THE DEVICE WAS POWERED UP AND DISPLAYED THE BATTERY DEPLETED MESSAGE WITH THE BATTERY ICON EMPTY. THE DEVICE WAS CONNECTED TO AC POWER AND A MESSAGE TO KEEP THE DEVICE PLUGGED INTO AC POWER WAS DISPLAYED. THE DEVICE PASSED A SELF-TEST ON AC POWER. WHEN DISCONNECTED FROM AC POWER, THE DEVICE DISPLAYED A DEPLETED BATTERY MESSAGE AND POWERED OFF. THE COMPLAINT WAS CONFIRMED. A NEW BATTERY WAS INSTALLED AND THE CHANGE BATTERY OPTION WAS KEYED. THE DEVICE THEN PASSED TESTING. THE PROBABLE CAUSE OF A COMBINATION OF A DEPLETED BATTERY AND CHANGE BATTERY OPTION NOT KEYED IS RELATED TO A KNOWN SOFTWARE ISSUE IN VERSION 15.02.00.008. DUE TO THE SOFTWARE ISSUE, WHEN THERE IS A REPLACE BATTERY CONDITION AND THE DEVICE IS DISCONNECTED FROM AC POWER, THE "DEPLETED BATTERY" ALARM OCCURS IN PLACE OF THE "REPLACE BATTERY" ALARM AND CAUSES THE PUMP TO SHUT DOWN AFTER 3 MINUTES.

  Patient problems: No Patient Involvement

  MAUDE report 7918891 ↗
• MalfunctionSep 28, 2018Premature Discharge of Battery; Premature Discharge of Battery

  THE EVENT INVOLVED A CUSTOMER ALLEGATION AGAINST A DEVICE THAT HAS A BROKEN BATTERY AND IS UNABLE TO BE CHARGED. DEVICE TESTING FOUND THE DEVICE GAVE A REPLACE BATTERY ALERT UPON POWERING ON AND DISPLAYED AN EMPTY BATTERY ICON DURING SELF-TEST. THE DEVICE WAS POWERED UP ON A/C (ALTERNATING CURRENT), THE CHANGE BATTERY SOFT KEY WAS PRESSED, AND THE DEVICE PASSED SELF-TEST ON D/C (DIRECT CURRENT). MULTIPLE N56 (WARNING REPLACE BATTERY) ALARMS WERE FOUND IN THE ALARM HISTORY LOG. THE COMPLAINT WAS CONFIRMED, AND THE PROBABLE CAUSE WAS FOUND TO BE RELATED TO A KNOWN SOFTWARE ISSUE IN VERSION 15.02.00.008. DUE TO THE SOFTWARE ISSUE, WHEN THERE IS A REPLACE BATTERY CONDITION AND THE DEVICE IS DISCONNECTED FROM AC POWER, THE "DEPLETED BATTERY" ALARM OCCURS IN PLACE OF THE "REPLACE BATTERY" ALARM AND CAUSES THE PUMP TO SHUT DOWN AFTER 3 MINUTES.

  Patient problems: No Patient Involvement

  MAUDE report 7918582 ↗
• MalfunctionSep 28, 2018Premature Discharge of Battery; Premature Discharge of Battery

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN 2018. THE EVENT INVOLVED A CUSTOMER ALLEGATION AGAINST A DEVICE THAT DOES NOT HOLD THE CHARGE. DEVICE TESTING FOUND THE DEVICE POWERED UP AND DISPLAYED THE BATTERY DEPLETED MESSAGE WITH AN EMPTY BATTERY ICON. WHILE THE DEVICE WAS CONNECTED TO A/C (ALTERNATING CURRENT) POWER, A MESSAGE TO KEEP DEVICE PLUGGED INTO A/C WAS DISPLAYED. THE DEVICE PASSED A SELF-TEST ON A/C. WHEN A/C WAS DISCONNECTED, THE DEVICE DISPLAYED A DEPLETED BATTERY MESSAGE AND POWERED OFF. THE COMPLAINT WAS CONFIRMED. A NEW BATTERY WAS INSTALLED, THE CHANGE BATTERY OPTION WAS KEYED AND THE DEVICE PASSED TESTING. SEVERAL N56 (WARNING REPLACE BATTERY) AND N252 (DEPLETED BATTERY) ALARMS WERE FOUND IN THE ALARM HISTORY LOG. THE PROBABLE CAUSE IS RELATED TO A KNOWN SOFTWARE ISSUE IN VERSION 15.02.00.008. DUE TO THE SOFTWARE ISSUE, WHEN THERE IS A REPLACE BATTERY CONDITION AND THE DEVICE IS DISCONNECTED FROM A/C POWER, THE "DEPLETED BATTERY" ALARM OCCURS IN PLACE OF THE "REPLACE BATTERY" ALARM AND CAUSES THE PUMP TO SHUT DOWN AFTER 3 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7918507 ↗
• MalfunctionSep 25, 2018Battery Problem; Battery Problem

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN 2018. THE EVENT INVOLVED THE CUSTOMER ALLEGATION THE DEVICE WAS NOT FUNCTIONING. DURING TESTING AND INVESTIGATION, THE DEVICE DISPLAYED A DEPLETED BATTERY MESSAGE WITH AN EMPTY BATTERY ICON, WHILE POWERED UP ON BATTERY. ADDITIONALLY, WHILE THE DEVICE WAS ON A/C POWER, A MESSAGE APPEARED TO KEEP THE DEVICE PLUGGED INTO A/C POWER. THE DEVICE HISTORY LOGS IDENTIFIED MULTIPLE, N56 (REPLACE BATTERY) AND N252 (DEPLETED BATTERY) ALARMS. THE DEVICE PASSED A SELF-TEST ON A/C. TESTING DETERMINED THE PROBABLE CAUSE WAS THE COMBINATION OF A DEPLETED BATTERY AND THE CHANGE BATTERY OPTION WAS NOT KEYED; THEREFORE, THE BATTERY WAS REPLACED AND THE BATTERY OPTION KEYED. THE DEVICE PASSED ALL PVT TESTING. THE COMPLAINT WAS CONFIRMED AND DETERMINED TO BE RELATED TO A KNOWN SOFTWARE ISSUE IN VERSION 15.02.00.008. DUE TO THE SOFTWARE ISSUE, WHEN THERE IS A REPLACE BATTERY CONDITION AND THE DEVICE IS DISCONNECTED FROM AC POWER, THE "DEPLETED BATTERY" ALARM OCCURS IN PLACE OF THE "REPLACE BATTERY" ALARM AND CAUSES THE PUMP TO SHUT DOWN AFTER 3 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7907163 ↗
• MalfunctionSep 13, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  THE EVENT INVOLVED A CUSTOMER REPORT OF A PUMP THAT IS BURNED IN THE REAR AND IN THE UPPER PART OF THE ALARM VOLUME CONTROL. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTS OF ADVERSE EVENTS OR DELAY IN CRITICAL THERAPY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7872541 ↗
• MalfunctionAug 14, 2018Failure to Run on Battery; Failure to Run on Battery

  THE CUSTOMER REPORTED THAT THE PUMP DOES NOT WORK ON BATTERY. DURING INVESTIGATION, THE DEVICE ALARMED FOR REPLACE BATTERY UPON POWER UP AND THE BATTERY ICON WAS EMPTY. THE DEVICE WAS POWERED UP ON AC POWER AND THE CHANGE BATTERY SOFT KEY WAS PRESSED AND THE DEVICE PASSED ALL THE TESTS ON DC POWER. DURING ALARM LOG REVIEW, MULTIPLE N56 (REPLACE BATTERY) ALARMS WERE FOUND. THE COMPLAINT WAS CONFIRMED AND THE PROBABLE CAUSE WAS DETERMINED TO BE RELATED TO A KNOWN SOFTWARE ISSUE IN VERSION 15.02.00.008. DUE TO THE SOFTWARE ISSUE, WHEN THERE IS A REPLACE BATTERY CONDITION AND THE DEVICE IS DISCONNECTED FROM AC POWER, THE "DEPLETED BATTERY" ALARM OCCURS IN PLACE OF THE "REPLACE BATTERY" ALARM AND CAUSES THE PUMP TO SHUT DOWN AFTER 3 MINUTES.

  Patient problems: No Patient Involvement

  MAUDE report 7782993 ↗
• MalfunctionAug 13, 2018Battery Problem; Battery Problem

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN 2018. THE EVENT INVOLVES A CUSTOMER ALLEGATION AGAINST A DEVICE THAT ALARMS N56 (REPLACE BATTERY). TESTING CONFIRMED THAT A REPLACE BATTERY ALARM (N56) OCCURRED DURING THE DEVICE'S SELF-TEST. THE BATTERY WAS CHARGED AND RESET SHOWING SUFFICIENT VDC (VOLTAGE DIRECT CURRENT). THE BATTERY WAS REPLACED TO RESOLVE THE ISSUE. THE PROBABLE CAUSE IS RELATED TO A KNOWN SOFTWARE ISSUE IN VERSION 15.02.00.008. DUE TO THE SOFTWARE ISSUE, WHEN THERE IS A REPLACE BATTERY CONDITION AND THE DEVICE IS DISCONNECTED FROM AC POWER, THE "DEPLETED BATTERY" ALARM OCCURS IN PLACE OF THE "REPLACE BATTERY" ALARM AND CAUSES THE PUMP TO SHUT DOWN AFTER 3 MINUTES.

  Patient problems: No Patient Involvement

  MAUDE report 7777643 ↗
• MalfunctionAug 9, 2018Premature Discharge of Battery; Premature Discharge of Battery

  THE EVENT INVOLVED A CUSTOMER ALLEGATION OF A DEVICE THAT DID NOT HOLD THE CHARGE. A REVIEW OF THE DEVICE HISTORY SHOWED THAT THE DEVICE HAD MULTIPLE N56 (REPLACE BATTERY) AND N252 (DEPLETED BATTERY) ALARMS. DURING INVESTIGATION, THE DEVICE WAS POWERED UP AND THE BATTERY DEPLETED MESSAGE WITH AN EMPTY BATTERY ICON WAS DISPLAYED. THE DEVICE WAS CONNECTED TO AC POWER AND A MESSAGE TO KEEP THE DEVICE PLUGGED INTO AC POWER WAS DISPLAYED. THE DEVICE PASSED THE SELF-TEST ON AC POWER. WHEN DISCONNECTED FROM AC POWER, THE DEVICE DISPLAYED A DEPLETED BATTERY MESSAGE AND POWERED OFF. THE BATTERY DID NOT CHARGE AND THE COMPLAINT WAS CONFIRMED. A NEW BATTERY WAS INSTALLED AND CHANGE BATTERY OPTION WAS KEYED. THE DEVICE THEN PASSED TESTING. THE PROBABLE CAUSE WAS A COMBINATION OF A DEPLETED BATTERY AND THE CHANGE BATTERY OPTION NOT BEING KEYED AND IS RELATED TO A KNOWN SOFTWARE ISSUE IN VERSION 15.02.00.008. DUE TO THE SOFTWARE ISSUE, WHEN THERE IS A REPLACE BATTERY CONDITION AND THE DEVICE IS DISCONNECTED FROM AC POWER, THE "DEPLETED BATTERY" ALARM OCCURS IN PLACE OF THE "REPLACE BATTERY" ALARM AND CAUSES THE PUMP TO SHUT DOWN AFTER 3 MINUTES.

  Patient problems: No Patient Involvement

  MAUDE report 7770343 ↗
• MalfunctionAug 8, 2018Battery Problem; Battery Problem

  THE EVENT OCCURED ON AN UNSPECIFIED DATE IN 2018. THE EVENT INVOLVED A CUSTOMER ALLEGATION OF A DEVICE THAT SAYS "NEEDS BATTERY REPLACED". DURING TESTING, THE FSE CONFIRMED THE REPLACE BATTERY MESSAGE AND DETERMINED THE PROBABLE CAUSE WAS THE END OF LIFE OF THE BATTERY. THE BATTERY WAS REPLACED. THIS PLUM 360 DEVICE HAS SOFTWARE VERSION (B)(4). THIS SOFTWARE HAS AN ISSUE WERE WHEN THERE IS A REPLACE BATTERY CONDITION AND THE DEVICE IS DISCONNECTED FROM AC POWER, THE "DEPLETED BATTERY" ALARM OCCURS IN PLACE OF THE "REPLACE BATTERY" ALARM AND CAUSES THE PUMP TO SHUT DOWN AFTER 3 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7763102 ↗
• MalfunctionMay 10, 2018Device Alarm System; Device Alarm System

  THE EVENT INVOLVED A CUSTOMER ALLEGATION THAT THE DEVICE ALARMED FOR N56 (REPLACE BATTERY). THIS PLUM 360 DEVICE HAS SOFTWARE VERSION 15.02.00.008. THE PLUM 360 SOFTWARE TRIGGERS A ¿REPLACE BATTERY¿ ALARM AFTER THREE BAD BATTERY COUNTS. DUE TO A DEFECT IN SOFTWARE VERSION 15.02.00.008, THE ALARM IS GENERATED AS ¿DEPLETED BATTERY¿ INSTEAD OF ¿REPLACE BATTERY,¿ WHICH CAUSES THE DEVICE TO ENTER A SHUTDOWN SEQUENCE ONCE AC IS UNPLUGGED.

  Patient problems: No Patient Involvement

  MAUDE report 7504042 ↗
• MalfunctionMay 4, 2018Battery Problem; Battery Problem

  THE EVENT INVOLVES A CUSTOMER ALLEGATION AGAINST A DEVICE THAT ALARMS N56 (REPLACE BATTERY). TESTING CONFIRMED THAT A REPLACE BATTERY ALARM (N56) OCCURRED. THE HISTORY SHOWED THE ERROR OCCURRED THREE TIMES DUE TO THE BATTERY NOT BEING CHARGED. THE BATTERY WAS CHARGED AND RESET SHOWING SUFFICIENT VDC. THE PROBABLE CAUSE IS RELATED TO A KNOWN SOFTWARE ISSUE IN VERSION 15.02.00.008. DUE TO THE SOFTWARE ISSUE, WHEN THERE IS A REPLACE BATTERY CONDITION AND THE DEVICE IS DISCONNECTED FROM AC POWER, THE "DEPLETED BATTERY" ALARM OCCURS IN PLACE OF THE "REPLACE BATTERY" ALARM AND CAUSES THE PUMP TO SHUT DOWN AFTER 3 MINUTES.

  Patient problems: No Patient Involvement

  MAUDE report 7486298 ↗
• MalfunctionMar 27, 2018Thermal Decomposition of Device; Battery Problem; Thermal Decomposition of Device; Battery Problem

  THE CUSTOMER REPORTED THAT THE DEVICE BATTERY OVERHEATED, THERE WAS A HOLE IN THE BATTERY, AND IT WAS HOT ENOUGH THAT THE BOTTOM OF THE CASE AND BATTERY DOOR BURNT. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 7373581 ↗
• MalfunctionDec 18, 2017Thermal Decomposition of Device; Thermal Decomposition of Device

  THE EVENT INVOLVED A CUSTOMER ALLEGATION OF A DEVICE WITH A SCORCHED GROUND PRONG ON THE AC CORD. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED. FOLLOW-UP 1: TESTING AND INVESTIGATION FOUND THAT THE GROUND PRONG ON THE AC CORD IS CHARRED/SCORCHED. THE AC CORD WAS PLUGGED INTO AN AC OUTLET, THE AC ICON ON THE DEVICE TURNED ON AND THE DEVICE TURNED ON USING AC. THERE WAS NO SPARKS, BURNING, OR SMOKE OBSERVED. THE AC PLUG WAS REMOVED AND NO SMELLS ASSOCIATED WITH CHARRING/SCORCHING WERE OBSERVED. THE ELECTRICAL ISSUES COULD NOT BE DUPLICATED AND NO PROBABLE CAUSE COULD BE DETERMINED.

  Patient problems: No Patient Involvement

  MAUDE report 7124514 ↗
• MalfunctionDec 13, 2017Battery Problem; Battery Problem

  THE EVENT INVOLVED A CUSTOMER ALLEGATION THAT THE DEVICE ALARMED FOR REPLACE BATTERY. THE CUSTOMER FURTHER REPORTED THAT THE BATTERY WAS REPLACED AND RESET THE NOTIFICATION IN THE SERVICE MODE AT THE USER FACILITY AND THE PUMP CONTINUES WITH THE ALARM FOR REPLACE BATTERY, BATTERY NOT INSTALLED, AND POWER OFF THEN ON AND REPLACE PUMP IF ALARM CONTINUES. A REVIEW OF THE DEVICE LOG DURING INVESTIGATION SHOWED THE N56 (REPLACE BATTERY) ALARM. TESTING FOUND THAT THE PUMP DID NOT PASS THE PVT SELF-TEST AS IT DISPLAYED ¿POWER OFF THEN ON. REPLACE PUMP IF ALARM CONTINUES¿, ALARMED FOR E437 (SOFTWARE FAILURE) AND DISPLAYED ¿BATTERY NOT INSTALLED¿. THE FSE REPORTED THAT THE BATTERY WAS REPLACED AND THE PUMP PASSED THE PVT SELF-TEST, AND DETERMINED THE PROBABLE CAUSE WAS A DEFECTIVE BATTERY. THIS REPORTED COMPLAINT WAS DETERMINED TO BE ASSOCIATED WITH A KNOWN S/W DEFECT WHICH IS RELATED TO A KNOWN SOFTWARE ISSUE IN VERSION 15.02.00.008. DUE TO THE SOFTWARE ISSUE, WHEN THERE IS A REPLACE BATTERY CONDITION AND THE DEVICE IS DISCONNECTED FROM AC POWER, THE "DEPLETED BATTERY" ALARM OCCURS IN PLACE OF THE "REPLACE BATTERY" ALARM AND CAUSES THE PUMP TO SHUT DOWN AFTER 3 MINUTES.

  Patient problems: No Patient Involvement

  MAUDE report 7115440 ↗
• MalfunctionNov 13, 2017Thermal Decomposition of Device; Device Emits Odor; Thermal Decomposition of Device; Device Emits Odor

  THE EVENT INVOLVED A CUSTOMER ALLEGATION THAT THERE WAS A BURNT BOARD AND IT SMELLED LIKE BURNED PLASTIC OR AN ELECTRONIC COMPONENT. DURING VISUAL INSPECTION, FSE TESTING CONFIRMED BURNT COMPONENTS WERE FOUND ON THE POWER SUPPLY AND DETERMINED THE PROBABLE CAUSE WAS DAMAGE TO THE POWER SUPPLY BOARD. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES, WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7025789 ↗
• MalfunctionOct 19, 2017Battery Problem; Battery Problem

  THE CUSTOMER REPORTED THAT THE DEVICE ALARMED FOR N56 (REPLACE BATTERY). A REVIEW OF THE ENTIRE DEVICE LOG DURING INVESTIGATION SHOWED N56 (REPLACE BATTERY) MESSAGES. THE DEVICE BATTERY WAS RESET IN BIOMED MODE AND CHARGED. THE COMPLAINT WAS CONFIRMED AND THE PROBABLE CAUSE WAS THE DEVICE NOT BEING CHARGED, WHICH IS RELATED TO A KNOWN SOFTWARE ISSUE IN VERSION 15.02.00.008. DUE TO THE SOFTWARE ISSUE, WHEN THERE IS A REPLACE BATTERY CONDITION AND THE DEVICE IS DISCONNECTED FROM AC POWER, THE "DEPLETED BATTERY" ALARM OCCURS IN PLACE OF THE "REPLACE BATTERY" ALARM AND CAUSES THE PUMP TO SHUT DOWN AFTER 3 MINUTES.

  Patient problems: No Patient Involvement

  MAUDE report 6963452 ↗
• MalfunctionOct 19, 2017Battery Problem; Battery Problem

  THE CUSTOMER REPORTED THAT THE DEVICE ALARMED FOR N56 (REPLACE BATTERY). A REVIEW OF THE ENTIRE DEVICE LOG DURING INVESTIGATION SHOWED N56 (REPLACE BATTERY) MESSAGES. THE DEVICE BATTERY WAS RESET IN BIOMED MODE AND CHARGED. THE COMPLAINT WAS CONFIRMED AND THE PROBABLE CAUSE WAS THE DEVICE NOT BEING CHARGED, WHICH IS RELATED TO A KNOWN SOFTWARE ISSUE IN VERSION 15.02.00.008. DUE TO THE SOFTWARE ISSUE, WHEN THERE IS A REPLACE BATTERY CONDITION AND THE DEVICE IS DISCONNECTED FROM AC POWER, THE "DEPLETED BATTERY" ALARM OCCURS IN PLACE OF THE "REPLACE BATTERY" ALARM AND CAUSES THE PUMP TO SHUT DOWN AFTER 3 MINUTES.

  Patient problems: No Patient Involvement

  MAUDE report 6962878 ↗
• MalfunctionSep 14, 2017Battery Problem; Battery Problem

  THE CUSTOMER REPORTED THE DEVICE ALARMED FOR N56 (REPLACE BATTERY). A REVIEW OF THE HISTORY LOG DURING INVESTIGATION CONFIRMED N56 (REPLACE BATTERY). DURING VISUAL INSPECTION THE BATTERY INDICATOR WAS FOUND TO BE EMPTY. THE BATTERY WAS CHARGED AND THE BATTERY SOFT KEY WAS RESET. THE BATTERY THEN SHOWED SUFFICIENT VOLTS DC. THE PROBABLE CAUSE WAS DUE TO THE BATTERY NOT BEING CHARGED AND IS RELATED TO A KNOWN SOFTWARE ISSUE IN VERSION 15.02.00.008. DUE TO THE SOFTWARE ISSUE, WHEN THERE IS A REPLACE BATTERY CONDITION AND THE DEVICE IS DISCONNECTED FROM AC POWER, THE "DEPLETED BATTERY" ALARM OCCURS IN PLACE OF THE "REPLACE BATTERY" ALARM AND CAUSES THE PUMP TO SHUT DOWN AFTER 3 MINUTES.

  Patient problems: No Patient Involvement

  MAUDE report 6865406 ↗
• MalfunctionSep 14, 2017Battery Problem; Battery Problem

  THE CUSTOMER REPORTED THE DEVICE ALARMED TO SERVICE BATTERY. A REVIEW OF THE HISTORY LOG DURING INVESTIGATION CONFIRMED N56 (REPLACE BATTERY) AND THE BATTERY ASSEMBLY WAS REPLACED. THE PROBABLE CAUSE WAS DUE A DEPLETED BATTERY AND IS RELATED TO A KNOWN SOFTWARE ISSUE IN VERSION 15.02.00.008. DUE TO THE SOFTWARE ISSUE, WHEN THERE IS A REPLACE BATTERY CONDITION AND THE DEVICE IS DISCONNECTED FROM AC POWER, THE "DEPLETED BATTERY" ALARM OCCURS IN PLACE OF THE "REPLACE BATTERY" ALARM AND CAUSES THE PUMP TO SHUT DOWN AFTER 3 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6865405 ↗
• MalfunctionSep 14, 2017Battery Problem; Battery Problem

  THE CUSTOMER REPORTED THE DEVICE ALARMED FOR N56 (REPLACE BATTERY). A REVIEW OF THE HISTORY LOG DURING INVESTIGATION CONFIRMED N56 (REPLACE BATTERY). DURING VISUAL INSPECTION THE BATTERY INDICATOR WAS FOUND TO BE EMPTY. THE BATTERY WAS CHARGED AND RESET IN THE BIOMED MODE. THE BATTERY THEN SHOWED SUFFICIENT VOLTS DC. THE PROBABLE CAUSE WAS DUE TO THE BATTERY NOT BEING CHARGED AND IS RELATED TO A KNOWN SOFTWARE ISSUE IN VERSION 15.02.00.008. DUE TO THE SOFTWARE ISSUE, WHEN THERE IS A REPLACE BATTERY CONDITION AND THE DEVICE IS DISCONNECTED FROM AC POWER, THE "DEPLETED BATTERY" ALARM OCCURS IN PLACE OF THE "REPLACE BATTERY" ALARM AND CAUSES THE PUMP TO SHUT DOWN AFTER 3 MINUTES.

  Patient problems: No Patient Involvement

  MAUDE report 6865403 ↗