KORU F10050-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00659443004450), received between Nov 15, 2024 and Aug 25, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Unintended Ejection” (23 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Unintended Ejection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50434823 ↗
• MalfunctionAug 4, 2026Unintended Ejection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50129673 ↗
• MalfunctionAug 4, 2026Unintended Ejection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50129672 ↗
• MalfunctionJul 6, 2026Unintended Ejection

  KORU MEDICAL BECAME AWARE OF A REPORT STATING, "DURING TESTING, SPRING-LOADED SYRINGE HOLDER DAMAGE; THE SYRINGE SHOOTS OUT OF THE COMPARTMENT." NO ADVERSE EVENTS OCCURRED. THIS EVENT OCCURRED DURING MAINTENANCE TESTING BY MCKESSON. THERE WAS NO PATIENT INVOLVEMENT. THE PUMP REFERENCED IN THIS REPORT WAS RECEIVED BY KORU MEDICAL SYSTEMS ON (B)(6) 2026 AND IS PENDING EVALUATION AT THIS TIME. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25719617 ↗
• MalfunctionApr 7, 2026Unintended Ejection

  KORU MEDICAL BECAME AWARE OF A REPORT STATING "DURING TESTING, THE SYRINGE SHOOTS OUT OF THE COMPARTMENT, SPRING DAMAGED." NO ADVERSE EVENTS OCCURRED. THIS EVENT OCCURRED DURING MAINTENANCE TESTING BY MCKESSON. THERE WAS NO PATIENT INVOLVEMENT. THE PUMP REFERENCED IN THIS REPORT WAS RECEIVED BY KORU MEDICAL SYSTEMS ON 24-MAR-2026. EVALUATION OF THE RETURNED PUMP IDENTIFIED DAMAGE TO THE PUMP HOUSING. A REPLACEMENT PUMP WAS PROVIDED TO THE CUSTOMER. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24808995 ↗
• MalfunctionApr 7, 2026Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5183981 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "PT STATED THAT HER PUMP HAD BROKEN. WHEN SHE TRIED TO START THE PUMP AFTER LOADING IN HER 2ND SYRINGE IT POPPED OUT AND SHE WAS NOT ABLE TO RESTART PUMP OR WIND PUMP AFTERWARDS. THE SUSPECT DEVICE SERIAL NUMBER WAS NOT PROVIDED BY THE PATIENT. THE FOLLOWING DEVICE SERIAL NUMBERS ARE CURRENTLY CHECKED OUT BY THE PATIENT FOR USE: SERIAL NUMBER - (B)(6) NO FURTHER INFORMATION. INDICATION - OTHER COMMON VARIABLE IMMUNODEFICIENCIES." ADDITIONAL INFORMATION WAS RECEIVED PROVIDING PATIENT INFORMATION AND THE SERIAL NUMBER OF THE PUMP INVOLVED. THE PUMP LISTED IN THIS REPORT HAS NOT BEEN RECEIVED BY KORU MEDICAL. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801715 ↗
• MalfunctionMar 30, 2026Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5183090 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "PT HUSBAND REPORTING THAT CURRENT FREEDOM PUMP NO LONGER HOLDS SYRINGE IN PLACE AND THEY HAD TO ZIP TIE. PER HUSBAND, ALSO MENTIONED THAT DURING HHRN VISIT, THE SYRINGE HAD COMPLETELY SHOT OUT OF THE PUMP. NO DOSES MISSED. UNKNOWN IF MD AWARE. UNKNOWN IF PATIENT EXPERIENCED ANY ADVERSE EVENTS. UNKNOWN IF PRODUCT IS AVAILABLE FOR RETURN. UNKNOWN IF MD AWARE. NO FURTHER INFORMATION, DETAILS, OR DATES AVAILABLE." ADDITIONAL INFORMATION WAS RECEIVED PROVIDING PATIENT INFORMATION AND THE SERIAL NUMBER OF THE PUMP INVOLVED. THE PUMP LISTED IN THIS REPORT HAS NOT BEEN RECEIVED BY KORU MEDICAL. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714336 ↗
• MalfunctionFeb 25, 2026Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5182008 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING: "PER PT, ON SATURDAY SYRINGE SHOT OUT OF THE PUMP, WAS ABLE TO FINISH THE INFUSION AFTER PLACING SYRINGE BACK INTO PUMP. PUMP WON'T WIND UP ANYMORE. PER PT, HAD RESPIRATORY ILLNESS FOR PAST MONTH, MAYBE COVID SINCE PT'S HUSBAND HAD COVID THAT WAS FOUND UPON TESTING AT HOSPITAL. PC REPORT SUBMITTED. FORWARDED TO RAVEN PSR FOR SCHEDULING. SERIAL NUMBER- (B)(6). DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PATIENT? YES, DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO; IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? YES, UPON PATIENT RETURN DID WE REPLACE DEVICE? YES, WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. DIAGNOSIS FOR USE: NONFAMILIAL HYPOGAMMAGLOBULINEMIA." ADDITIONAL INFORMATION WAS RECEIVED PROVIDING PATIENT INFORMATION AND THE SERIAL NUMBER OF THE PUMP INVOLVED. THE PUMP LISTED IN THIS REPORT HAS NOT BEEN RECEIVED BY KORU MEDICAL. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY. HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443974 ↗
• MalfunctionDec 15, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF A REPORT STATING "DURING SETUP, THE PATIENT STATED THEY SET EVERYTHING UP AS USUAL AND WAS JUST STARTING THE PRIMING. WHEN THE PUMP WAS TURNED ON, THE BLACK TAB SPRUNG FORWARD QUICKLY FROM THE BACK AND EJECTED THE SYRINGE FORCEFULLY OUT, A FEW FEET AWAY AND ONTO THE FLOOR. THE TIP OF THE SYRINGE AND THE TUBING FLANGE WERE BOTH CRACKED AFTER IMPACT. THE BLACK TAB ON THE PUMP WILL NOT REWIND, SO THE INTERNAL SPRING MECHANISM MUST HAVE FAILED SUDDENLY AND FORCEFULLY. THE PATIENT SEALED AND BAGGED THE SYRINGE AND TUBING AND WILL RETURN WITH THE PUMP AND STATED THE HIZENTRA AND SUPPLIES WILL NEED TO BE REPLACED. THE PUMP HAD BEEN STORED PROPERLY AND HAS NOT BEEN DROPPED OR DAMAGED." A RETURN MATERIAL AUTHORIZATION WAS INITIATED BY KORU MEDICAL FOR PRODUCT RETURN. THE PUMP LISTED IN THIS REPORT HAS NOT BEEN RECEIVED BY KORU MEDICAL AT THIS TIME. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804418 ↗
• MalfunctionDec 15, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF A REPORT STATING "PATIENT STATES PUMP IS NOT WORKING AS IT SHOULD. SHE HAD TO TRY SEVERAL TIMES TO LOAD SYRINGE AND ONE TIME THE SYRINGE SHOT OUT FROM THE HOLDER." NO ADVERSE EVENTS OCCURRED. A RETURN MATERIAL AUTHORIZATION WAS INITIATED BY KORU MEDICAL FOR PRODUCT RETURN. THE PUMP LISTED IN THIS REPORT HAS NOT BEEN RECEIVED BY KORU MEDICAL AT THIS TIME. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804417 ↗
• InjuryDec 8, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  KORU MEDICAL BECAME AWARE OF MW5177924 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "(B)(6) HOME HEALTH RN (REGISTERED NURSE) REPORTED PT (PATIENT) HAD ALLERGIC REACTION TO HIZENTRA INFUSION (B)(6) 2025. RN REPORTED A FEW MINUTES INTO INFUSION, PT STARTED TO FEEL ITCHY, RN SWITCHED OUT TAPE AND THAT IS WHEN RN NOTICED FREEDOM PUMP MALFUNCTIONED AND INFUSED THE TOTAL AMOUNT IN A FEW MINUTES INSTEAD OF AN 1 HOUR AND 43 MINUTES AS EXPECTED. RN CONFIRMED THEY SET UP PUMP WITH CORRECT TUBING/NEEDLE SET. PT HAD HOARSE VOICE, ITCHINESS, REDNESS AT INFUSION SITES, NAUSEA AND HEART PALPITATIONS, NO SHORTNESS OF BREATH. RN GAVE IV (INTRAVENOUS) SOLUMEDROL, EPI-PEN, BENADRYL, CIMETIDINE AND CROMOLYN. RN WAS UNABLE TO GET IV ACCESS TO GIVE IV FLUIDS AS PER ANAPHYLAXIS PROTOCOL. RN STAYED IN PT'S HOME FOR 3 HOURS AND PT WAS ABLE TO FALL ASLEEP. RN WENT BACK TO PT'S HOME TODAY FOR FOLLOW UP AND PT IS NOT HAVING ANY CONCERNS. ALL KNOWN INFORMATION IS CONTAINED ON THIS FORM. CONSENT TO CONTACT THE REPORTER HAS NOT BEEN RECEIVED, FOR FOLLOW UP PLEASE CONTACT THE PRESCRIBER. PUMP SERIAL NUMBER AND EXPIRATION UNKNOWN. NO FURTHER INFORMATION, DETAILS OR DATES AVAILABLE. PRODUCT LOT AND EXPIRATION

  Patient problems: Arrhythmia; Hypersensitivity/Allergic reaction; Itching Sensation; Local Reaction; Nausea; Voice alteration

  MAUDE report 23744337 ↗
• MalfunctionDec 1, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5177470 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "PATIENT REPORTS THEIR FREEDOM PUMP, SERIAL NUMBER (B)(6), IS NOT WORKING CORRECTLY, STATES IT IS DEFECTIVE. PATIENT STATES DURING THEIR HIZENTRA INFUSION, YESTERDAY, THE SYRINGE FLEW OUT OF THE PUMP AND THE PATIENT HAD TO HOLD THE SYRINGE DOWN DURING THE INFUSION. PATIENT CONFIRMED THE FLOW RATE TUBING WAS ATTACHED. PATIENT DID NOT MISS A DOSE, NOR HAVE AN INTERRUPTION IN THERAPY AND DID NOT REPORT AN ADVERSE EVENT DUE TO MALFUNCTIONING PUMP. THE PHARMACY IS REPLACING THE PUMP AND THE MALFUNCTIONING PUMP WILL BE RETURNED, BOX HAS BEEN SENT. UNKNOWN IF MD IS AWARE. NO FURTHER INFORMATION, DETAILS, OR DATES PROVIDED. INDICATION: MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY DISEASE." NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT. FOLLOW UP WITH THE INITIAL REPORTER IS BEING CONDUCTED FOR ADDITIONAL DETAILS. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681074 ↗
• MalfunctionNov 17, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5176860 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING " PT REPORTED THEIR PUMP IS BROKEN. PT REPORTED THE SYRINGE KEPT POPPING OUT AND WOULD NOT STAY IN THE PUMP ALONE WITH THE BLACK TAB/SPRING IS BROKEN. RPH CONFIRMED WITH PT THAT THEY ARE TRANSFERRING ALL OF THE MEDICATION DOSE INTO THE SYRINGE FOR ADMINISTRATION; PT IS NOT USING THE MANUFACTURER PREFILLED SYRINGE DIRECTLY IN THE PUMP WITH ADAPTER. RPH CONFIRMED WITH PT THE ADAPTER PIECE IS NOT LEFT IN PUMP AND CONFIRMED PT DID NOT CONNECT THE F-TUBING BACKWARDS. NO FURTHER INFORMATION, DETAILS OR DATES AVAILABLE. PRODUCT LOT AND EXPIRATION UNKNOWN. UNKNOWN IF MD IS AWARE. DOSE/AMOUNT: HIZENTRA - 31GM. HIZENTRA INDICATION: MYASTHENIA GRAVIS WITHOUT (ACUTE) EXACERBATION; MYASTHENIA GRAVIS WITH (ACUTE) EXACERBATION. DID PT MISS A DOSE OR HAVE AN INTERRUPTION TO THERAPY? UNKNOWN; DID ADVERSE EVENT(S) RESULT DUE TO PRODUCT ISSUE? UNKNOWN; DID PHARMACY REPLACE DEVICE? YES; IS DEVICE ASSOCIATED WITH EVENT AVAILABLE FOR RETURN? - UNKNOWN." ADDITIONAL INFORMATION WAS RECEIVED PROVIDING PATIENT INFORMATION, HOWEVER SERIAL NUMBER OF THE DEVICE IS UNKNOWN. THE PUMP LISTED IN THIS REPORT HAS NOT BEEN RECEIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569572 ↗
• MalfunctionNov 17, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5177183 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "PT REPORTS SHE IS IN PROCESS OF STARTING NEW TREATMENT AND IS HAVING ISSUES WITH THE PUMP, BECAUSE THE SYRINGE BEGINS TO SHOOT OUT AS SOON AS SHE STARTS THE PUMP, AND IS NOT SURE IF SHE MAY HAVE DONE SOMETHING WRONG. PT SWITCHED OUT NEEDLE SET AND CHANGED ADMINISTRATION SITES, BUT STILL WOULDN'T WORK. PT TRIED TO MANUALLY COMPLETE INFUSION BUT WAS ONLY ABLE TO GIVE HERSELF ABOUT 5 GM OF 16 GM DOSE. NO ADDITIONAL INFORMATION OR DETAILS AVAILABLE. NO ADVERSE EVENTS REPORTED. UNKNOWN IF AVAILABLE FOR RETURN. PHARMACY IS REPLACING THE DEVICE. DEVICE SERIAL NUMBER: (B)(6)." ADDITIONAL INFORMATION WAS RECEIVED PROVIDING PATIENT INFORMATION AND THE SERIAL NUMBER OF THE PUMP INVOLVED. THE PUMP LISTED IN THIS REPORT HAS NOT BEEN RECEIVED BY KORU MEDICAL. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569228 ↗
• MalfunctionNov 14, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5176493 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "PATIENT'S MOM REPORTING FREEDOM PUMP BROKE. DURING INFUSION, THE PUMP SHOT SYRINGE FILLED WITH HIZENTRA OUT OF THE PUMP. SENDING PT NEW FREEDOM PUMP TO REPLACE THE BROKEN ONE. PT HAD OLD PUMP AND WAS ABLE TO COMPLETE INFUSION WITH THAT. PUMP EXPIRATION DATE: 2026-02-26 SERIAL NUMBER (B)(6). PUMP START DATE: (B)(6) 2025. UNKNOWN IF PATIENT MISSED A DOSE. UNKNOWN IF AN ADVERSE EVENT TOOK PLACE. UNKNOWN IF PATIENT HAS PICTURES TO PROVIDED. UNKNOWN IF PUMP IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION, DETAILS, OR DATES PROVIDED. DOSE AND FREQUENCY: INFUSE 11GM (55ML) UNDER THE SKIN EVERY 2 WEEKS. MAX INFUSION RATE UP TO 15-25ML PER HR PER INJECTION SITE OR AS INSTRUCTED BY PRESCRIBER." ADDITIONAL INFORMATION WAS RECEIVED PROVIDING PATIENT INFORMATION AND THE SERIAL NUMBER OF THE PUMP INVOLVED. THE PUMP LISTED IN THIS REPORT HAS NOT BEEN RECEIVED BY KORU MEDICAL. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556455 ↗
• MalfunctionNov 14, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5176433 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "PATIENT REPORTS HAVING AN ISSUE WITH PUMP NOT HOLDING THE 50/60ML SYRINGE. THE PUMP DOES NOT HAVE THE ADAPTOR ON AND PT SAYS THE 50ML SYRINGE KEEPS POPPING OUT. SENT HIZENTRA HOW TO INFUSE VIDEO AND FOLLOWED ALONG WITH PT BUT SYRINGE STILL POPPING OUT. COUNSELED PT THAT SHE WILL HAVE TO WASTE TODAY'S DOSE OF HIZENTRA (ONLY GOOD FOR 8HRS IN SYRINGE) WE WILL REPLACE THE WASTED DOSE AND WE WILL SEND ANOTHER NEW PUMP. PUMP SERIAL NUMBER. UNKNOWN IF PUMP IS AVAILABLE FOR POSSIBLE RETURN." ADDITIONAL INFORMATION WAS RECEIVED PROVIDING PATIENT INFORMATION AND THE SERIAL NUMBER OF THE PUMP INVOLVED. THE PUMP LISTED IN THIS REPORT HAS NOT BEEN RECEIVED BY KORU MEDICAL. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556055 ↗
• MalfunctionAug 25, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF A REPORT STATING "DURING SETUP, PATIENT (SHE) INSERTED THE SYRINGE LIKE NORMAL, IT EJECTED THE SYRINGE. (SHE) CAUGHT IT. PATIENT WAS ABLE TO INFUSE DOSE USING ANOTHER PUMP THEY RECEIVED FROM PREVIOUS PHARMACY." NO ADVERSE EVENTS OCCURRED. A RETURN MATERIAL AUTHORIZATION WAS INITIATED FOR RETURN OF THE PUMP TO KORU MEDICAL FOR EVALUATION. THE PUMP LISTED IN THIS REPORT WAS RECEIVED BY KORU MEDICAL ON 19-AUG-2025 AND IS PENDING EVALUATION A THIS TIME. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22887372 ↗
• MalfunctionAug 4, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF A REPORT STATING "PATIENT ATTEMPTED TO START INFUSION AFTER INSERTING THE 50 ML SYRINGE INTO THE PUMP, BUT THE SYRINGE POPPED OUT OF THE PUMP WHEN TURNED ON. HE CONFIRMED THAT THE BLACK TAB WAS WINDED TO THE END OF THE TRACK, AND THAT THE SYRINGE WAS SEATED PROPERLY. HE THINKS THAT THE SPRING INSIDE THE PUMP IS BROKEN AND ENDED UP WASTING THE DOSE. HE CONTACTED THE PHARMACY THE NEXT BUSINESS DAY AND REPORTED THE ISSUE. PHARMACY SENT OUT A REPLACEMENT PUMP AND RETRIEVED THE BROKEN PUMP." NO ADVERSE EVENTS OCCURRED. A RETURN MATERIAL AUTHORIZATION WAS INITIATED FOR RETURN OF THE PUMP TO KORU MEDICAL FOR EVALUATION. THE PUMP LISTED IN THIS REPORT WAS RECEIVED BY KORU MEDICAL ON 30-JULY-2025 AND IS PENDING EVALUATION A THIS TIME. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708253 ↗
• MalfunctionJul 3, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5170953 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "INDICATION: COMMON VARIABLE IMMUNODEFICIENCY, UNSPECIFIED. PT REPORTS THEY WERE INFUSING HIZENTRA TODAY AND THE PREFILLED SYRINGE KEEPS EJECTING OUT OF THE PUMP (SERIAL NUMBER AND EXPIRATION DATE NOT PROVIDED) WHEN SHE TURNS IT ON. SPRING IS BROKEN. PT HAD ANOTHER FREEDOM 60 PUMP AND WAS SUCCESSFULLY ABLE TO START INFUSION WITH IT. NO ADVERSE EVENT(S) REPORTED DUE TO PRODUCT ISSUE. PHARMACY REPLACING DEVICE. RETURN MATERIAL SENT FOR RETURN OF DEVICE ASSOCIATED WITH EVENT. AVAILABILITY OF DEVICE FOR INVESTIGATION DEPENDENT ON PT RETURNING IT. NO FURTHER INFO." ADDITIONAL INFORMATION WAS RECEIVED PROVIDING PATIENT INFORMATION AND THE SERIAL NUMBER OF THE PUMP INVOLVED. THE PUMP LISTED IN THIS REPORT HAS NOT BEEN RECEIVED BY KORU MEDICAL. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396036 ↗
• MalfunctionJul 3, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5170949 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "INDICATION: NONFAMILIAL HYPOGAMMAGLOBULINEMIA; OTHER COMMON VARIABLE IMMUNODEFICIENCIES; SELECTIVE DEFICIENCY OF IMMUNOGLOBULIN A [IGA]; HEREDITARY HYPOGAMMAGLOBULINEMIA. PT REPORTS SYRINGE WOULD NOT STAY IN PUMP. PUMP (SERIAL NUMBER AND EXPIRATION DATE NOT PROVIDED) KEPT PUSHING IT OUT OF PLACE MULTIPLE TIMES TO THE POINT OF EXPELLING THE ENTIRE SYRINGE PER PT. AFTER MULTIPLE ATTEMPTS AT TRYING TO GAUGE WHETHER PT WAS REFERRING TO THE EMPTY 50 ML SYRINGE OR THE ORIGINAL 50 ML HIZENTRA, IT REMAINED UNCLEAR. PT SEEMED A BIT CONFUSED. PT WAS ADVISED TO DISPOSE OF THE SYRINGE AND NOT USE IT AS STABILITY COULD NOT BE ASSESSED. PT STATED SHE HAS ENOUGH MEDICATION ON HAND. PHARMACY REPLACING PUMP. BOX SENT FOR RETURN OF DEVICE ASSOCIATED WITH EVENT. AVAILABILITY OF PUMP FOR INVESTIGATION DEPENDENT ON PT'S RETURN. NO MISSED DOSE OR INTERRUPTION TO THERAPY REPORTED. NO ADVERSE EVENT(S) REPORTED DUE TO PRODUCT ISSUE. NO FURTHER INFO." ADDITIONAL INFORMATION WAS RECEIVED PROVIDING PATIENT INFORMATION AND THE SERIAL NUMBER OF THE PUMP INVOLVED. THE PUMP LISTED IN THIS REPORT HAS NOT BEEN RECEIVED BY KORU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396035 ↗
• MalfunctionMay 5, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5168121 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING " PT (PATIENT) WIFE REPORTS THAT FREEDOM PUMP BROKE DURING INFUSION TODAY AND PATIENT STILL HAS ONE REMAINING SYRINGE TO INFUSE. PT WIFE REPORTS THAT WHEN THEY TRIED TO TUM DIAL BACK TO MOVE BLACK PIECE SO THAT SYRINGE WOULD LOAD IN THE PUMP, THE BLACK PIECE SHOT FORWARD AND LAUNCHED SYRINGE OUT OF THE PUMP. PT WAS NOT ABLE TO TURN DIAL AGAIN AFTER THAT. RPH (REGISTERED PHARMACIST) ADVISED WE WILL SEND A NEW FREEDOM PUMP. SERIAL NUMBER UNKNOWN. NO ADVERSE EVENTS REPORTED. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER." A GOOD FAITH EFFORT WAS SENT TO THE INITIAL REPORTER ON 10-APR-2025 FOR ADDITIONAL INFORMATION. A RESPONSE WAS RECEIVED PROVIDING PATIENT INFORMATION AND THE SERIAL NUMBER OF THE PUMP INVOLVED. THE PUMP LISTED IN THIS REPORT HAS NOT BEEN RECEIVED BY KORU MEDICAL. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21963462 ↗
• MalfunctionMay 5, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5168118 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "PATIENT REPORTS SHE WENT TO PUT 2ND SYRINGE (40 ML) IN PUMP, WOUND IT BACK AND THEN IT WENT FORWARD AND PUSHED THE WHOLE THING UP AND OUT AND CAN'T WIND IT BACK AT ALL. NO ADVERSE EVENTS REPORTED. SERIAL NUMBER IS UNKNOWN. REPORTED (B)(6) BY: PATIENT/CAREGIVER." A GOOD FAITH EFFORT WAS SENT TO THE INITIAL REPORTER ON 10-APR-2025 FOR ADDITIONAL INFORMATION. A RESPONSE WAS RECEIVED PROVIDING PATIENT INFORMATION AND THE SERIAL NUMBER OF THE PUMP INVOLVED. THE PUMP LISTED IN THIS REPORT HAS NOT BEEN RECEIVED BY KORU MEDICAL. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961643 ↗
• MalfunctionJan 13, 2025Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF MW5162696 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "PATIENT REPORTED PUMP NOT WORKING. PER PATIENT, SHE WAS DOING EVERYTHING SHE WAS INSTRUCTED TO DO. WIND UP IN OFF POSITION. INSERT SYRINGE AND TURN ON. WHEN SHE WOULD TURN ON THE PUMP, THE SYRINGE WOULD POP OUT AND WOULD NOT STAY IN PLACE. ADVISED THE PATIENT TO PUSH THE SYRINGE SLIGHTLY, BUT PATIENT STATED SYRINGE IS NOT STAYING SECURE. PATIENT AGREED TO MANUALLY PUSH 10GM DOSE. ADVISED PATIENT TO PUSH 4ML EVERY 5 MINUTES UNTIL DOSE IS COMPLETE. ADVISED PATIENT TO REMOVE TUBING BEFORE SINCE IT IS NOT NEEDED FOR MANUAL PUSH. FULL DOSE EXPECTED TO BE COMPLETED VIA MANUAL PUSH. PUMP AVAILABLE FOR RETURN. PHARMACY REPLACING DEVICE. NO ADVERSE EVENTS REPORTED. NO ADDITIONAL INFORMATION AVAILABLE. INDICATION: ANTIBODY DEFICIENCY WITH NEAR-NORMAL IMMUNOGLOBULINS OR WITH HYPERIMMUNOGLOBULINMIA. PUMP SERIAL NUMBER:(B)(6). REPORTED TO (8)(6) BY: PATIENT/CAREGIVER. " A GOOD FAITH EFFORT WAS SENT TO THE INITIAL REPORTER ON 19-DEC-2024 FOR ADDITIONAL INFORMATION. A RESPONSE WAS RECEIVED THE SAME DAY PROVIDING PATIENT INFORMATION AND THE SERIAL NUMBER OF THE PUMP INVOLVED. THE PUMP LISTED IN THIS REPORT HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21144667 ↗
• MalfunctionNov 15, 2024Unintended Ejection; Unintended Ejection

  KORU MEDICAL BECAME AWARE OF A REPORT ON 22-OCT-2024 STATING "DURING SET UP, PATIENT STATED WHEN SHE TRIED TO LOAD THE SYRINGE INTO THE PUMP, THE SYRINGE FELT LOOSE AND DID NOT ATTACH. WHEN THE PATIENT TURNED THE PUMP ON, THE GRABBER CAME DOWN AND FLINGED OUT THE SYRINGE. PATIENT TRIED TO HOLD DOWN THE SYRINGE BUT IT KEEPS FLINGING OUT." NO ADVERSE EVENTS OCCURRED AS A RESULT OF THE EVENT. THE PUMP HAS BEEN RETURNED TO KORU MEDICAL AND IS PENDING EVALUATION AT THIS TIME. KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20699770 ↗