Alaris 10015414Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 10885403233999), received between Jul 12, 2018 and Dec 22, 2025 — classified as 2 injuries, 94 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (52 reports).

2 FDA recall records name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 11, 2025Open, Classified

   Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

   Z-0035-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. May 6, 2019Terminated

   An incomplete occlusion can be caused by a variation in the wall thickness of the pumping segment of the affected infusion sets used with the. The issue has the potential to lead to unintended delivery of medication when the pump module is not in running status or can result in faster than expected drug delivery flow when the pump is infusing.

   Z-1770-2019 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT ALARIS PUMP INFUSION BLOOD SET 180 MICRON FILTER REF (B)(4) 1 OF 2 BAG SPIKE CAME APART FROM THE NON-VENTED DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866481 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT WHILE A NURSE WAS ATTEMPTING TO REMOVE OR FLICK AIR FROM THE TUBING, THE SOFT SECTION OF THE TUBING DISCONNECTED FROM THE CONNECTOR, RESULTING IN BLOOD SPLASHING ONTO THE NURSE. SUBSEQUENT SETS ALSO CAME APART AT THE TOP OF THE SOFT SECTION OF TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286181 ↗
• MalfunctionJun 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VEBATIM IT WAS REPORTED BY CUSTOMER THAT THE TUBING WAS LEAKING BLOOD FROM THE TOP OF THE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301632 ↗
• MalfunctionJun 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD ALARIS PUMP INFUSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE TUBING WAS LEAKING BLOOD FROM THE TOP OF THE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301631 ↗
• MalfunctionDec 5, 2024Leak/Splash; Leak/Splash

  MATERIAL: 10015414. BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT NOTED BLOOD ON IV POLE AND THROUGHOUT INTERIOR OF THE PUMP CHANNEL AFTER TRANSFUSION. NO NOTABLE HOLE BUT POSSIBLY COMING FROM JUST BELOW THE BLUE HARD PLASTIC PIECE WHERE THE TUBING IS FED INTO THE CHANNEL. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REPORTER NOTED BLOOD ON IV POLE AND THROUGHOUT INTERIOR OF THE PUMP CHANNEL AFTER TRANSFUSION. NO NOTABLE HOLE BUT POSSIBLY COMING FROM JUST BELOW THE BLUE HARD PLASTIC PIECE WHERE THE TUBING IS FED INTO THE CHANNEL. PUMP DID NOT ALARM WITH A PROBLEM THROUGHOUT THE WHOLE 2 HOUR TRANSFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20858155 ↗
• MalfunctionAug 5, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19914698 ↗
• MalfunctionAug 5, 2024Backflow; Backflow

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE BLOOD SET BACK FLOWED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: PATIENT WAS RECEIVING 2 UNITS OF BLOOD (DUE TO HIS 15 ML/KG HITTING THE MAX OF 2 UNITS). THE SECOND UNIT WAS RUNNING SLOWER, OVER 3 HOURS DUE TO DISCOMFORT IN THE PATIENT'S HAND DURING TRANSFUSION. AT THE END OF THE TRANSFUSION, THE CHAMBER OF THE TUBING HAD BLOOD IN THE BASE OF IT AND ALSO HAD BLOOD ON TOP OF THE CHAMBER BUT IN THE MIDDLE IT HAD "RUN DRY". SINCE THE BLOOD BAG HAD BEEN COMPLETED, I CLAMPED AND SWITCHED OVER TO THE NS FLUSH AND THE CHAMBER HAD BACK FLOWED INTO THE SALINE BAG, MIXING IT WITH BLOOD. ALL THROUGHOUT ANY ATTEMPTS OF RUNNING THE BLOOD OR THE FLUSH, THE PUMP WOULD CONTINUE TO SAY THAT THE PATIENT SIDE WAS OCCLUDED. DUE TO THE INABILITY OF FLUSHING THE TUBING, THE PATIENT DID NOT RECEIVE THE BLOOD LEFT IN THE TUBING BUT DID RECEIVE A FLUSH OF NS FOLLOWING THE TRANSFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19914697 ↗
• MalfunctionJul 25, 2024Backflow; Backflow

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE BLOOD SET WAS BACKFLOWING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: WE HAD ANOTHER BLOOD TUBING BACK-FLOW ISSUE, INVOLVING RBCS. AFTER THE CNS/CPL MEETING EARLIER THIS WEEK, AND BASED ON THE RECOMMENDATION FROM THE PERELMAN INFUSION NURSE, I ADVISED MY NURSES TO MAKE SURE THEY CLAMP THE FREE SPIKE RIGHT ABOVE THE CHAMBER. TURNS OUT MOST OF MY NURSES DO THAT ANYWAY, BUT IT WAS DONE WITH THIS TRANSFUSION AND DIDN¿T WORK. NURSE ENDED UP USING HEMOSTAT TO STOP THE RBCS FROM DRIPPING.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19828532 ↗
• MalfunctionJun 27, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE BLOOD SET WAS DEFECTIVE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE UNITS HAVE IDENTIFIED BACKFLOW ISSUES WITH OUR ADMINISTRATION OF BLOOD PRODUCTS, INCLUDING 3 TIMES IN THE PAST 3 WEEKS. SAME PRODUCT AS THE OTHER EVENTS- ALARIS BD BLOOD TUBING. THEY DID NOT SAVE PRODUCT AS IT HAS BECOME SUCH A REOCCURRENCE. I WILL ASK FOR PICTURES TO BE SAVED AT LEAST. EVENT DETAILS BELOW: BD ALARIS PUMP INFUSION BLOOD SET. BLOOD TUBING BACK PRIMED DESPITE BEING CLAMPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630555 ↗
• MalfunctionJun 26, 2024Backflow; Backflow

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE BLOOD SET HAD BACKFLOW THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE UNITS HAVE IDENTIFIED BACKFLOW ISSUES WITH OUR ADMINISTRATION OF BLOOD PRODUCTS, INCLUDING 3 TIMES IN THE PAST 3 WEEKS. SAME PRODUCT AS THE OTHER EVENTS- ALARIS BD BLOOD TUBING. THEY DID NOT SAVE PRODUCT AS IT HAS BECOME SUCH A REOCCURRENCE. I WILL ASK FOR PICTURES TO BE SAVED AT LEAST. EVENT DETAILS BELOW: WE CLAMPED THE BLOOD TUBING BUT THE BLOOD STILL GOT THROUGH IT/BACK FLOWED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19619463 ↗
• MalfunctionMay 15, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT ALARIS PUMP MODULE BLOOD SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: STAFF HAVE BEEN REPORTING THIS ISSUE HAS BEEN HAPPENING AND THE ONLY WAY TO RECTIFY IS REPRIMING WITH NEW TUBING. THEY HAVE TRIED SEVERAL DIFFERENT CHANNELS EACH TIME BUT THE ONLY RESOLUTION IS CHANGING THE TUBING. REF NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19324933 ↗
• MalfunctionMay 15, 2024Backflow; Backflow

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19324168 ↗
• MalfunctionApr 12, 2024Backflow; Backflow

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE BLOOD SET HAD VALVE MALFUNCTION THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: 1) 2 SIGNIFICANT ISSUE WITH BLOOD TUBING THIS AFTERNOON THAT AFFECTED OUR INFUSION OF ALLO STEM CELLS. OUR PRACTICE IS TO SPIKE A BAG OF SALINE WITH ONE OF THE BIFURCATED TUBES AND PRIME THE LINE. AFTER THE TUBING IS PRIMED WITH SALINE, WE CLAMP THE TUBE ATTACHED TO THE BAG OF SALINE AND THEN SPIKE THE BAG OF STEM CELLS WITH THE OTHER BIFURCATED TUBE. THE CELLS ARE THEN INFUSED THROUGH THE IV PUMP. FOR BOTH PATIENTS, THE CELLS BACK-PRIMED INTO THE BAG OF SALINE DESPITE IT BEING CLAMPED. FOR ONE OF THE INFUSIONS, WE WERE ABLE TO PINCH AND TIE OFF THE TUBING; IN THE OTHER, A SIGNIFICANT AMOUNT OF THE CELLS WENT INTO THE BAG OF SALINE. 2) SAME ISSUE OCCURRED YESTERDAY WITH BLOOD TUBING AND RBCS, I.E., BLOOD BACKFILLED INTO THE OTHER, CLAMPED SPIKE AND DRIPPED ONTO THE FLOOR. NOT SURE IF THE RN SAVED THE PACKAGE OR TUBING ¿ I¿LL CHECK. THE RN DOUBLE-CHECKED AND THE OTHER SPIKE WAS CLAMPED. THIS HAPPENING WITH BLOOD PRODUCTS IS ONE THING BUT WE USE BLOOD TUBING FOR INFUSING CELLS AND THIS IS VERY CONCERNING. WE ARE GIVING

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095360 ↗
• MalfunctionApr 12, 2024Backflow; Backflow

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE BLOOD SET HAD VALVE MALFUNCTION THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: 1) 2 SIGNIFICANT ISSUE WITH BLOOD TUBING THIS AFTERNOON THAT AFFECTED OUR INFUSION OF ALLO STEM CELLS. OUR PRACTICE IS TO SPIKE A BAG OF SALINE WITH ONE OF THE BIFURCATED TUBES AND PRIME THE LINE. AFTER THE TUBING IS PRIMED WITH SALINE, WE CLAMP THE TUBE ATTACHED TO THE BAG OF SALINE AND THEN SPIKE THE BAG OF STEM CELLS WITH THE OTHER BIFURCATED TUBE. THE CELLS ARE THEN INFUSED THROUGH THE IV PUMP. FOR BOTH PATIENTS, THE CELLS BACK-PRIMED INTO THE BAG OF SALINE DESPITE IT BEING CLAMPED. FOR ONE OF THE INFUSIONS, WE WERE ABLE TO PINCH AND TIE OFF THE TUBING; IN THE OTHER, A SIGNIFICANT AMOUNT OF THE CELLS WENT INTO THE BAG OF SALINE. 2) SAME ISSUE OCCURRED YESTERDAY WITH BLOOD TUBING AND RBCS, I.E., BLOOD BACKFILLED INTO THE OTHER, CLAMPED SPIKE AND DRIPPED ONTO THE FLOOR. NOT SURE IF THE RN SAVED THE PACKAGE OR TUBING ¿ I¿LL CHECK. THE RN DOUBLE-CHECKED AND THE OTHER SPIKE WAS CLAMPED. THIS HAPPENING WITH BLOOD PRODUCTS IS ONE THING BUT WE USE BLOOD TUBING FOR INFUSING CELLS AND THIS IS VERY CONCERNING. WE ARE GIVING

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095358 ↗
• MalfunctionJan 19, 2024Backflow; Backflow

  IT WAS REPORTED THAT BD ALARIS PUMP MODULE BLOOD SET HAD BLOOD BACKFLOW THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: ADDITIONAL PROBLEM WAS NOTED ON THE SAME UNIT, A FEW DAYS EARLIER. THIS EVENT STATED ¿DURING A TRANSFUSION, BLOOD WAS BACKING UP INTO THE OTHER Y SITE LINE EVEN WITH IT CLAMPED. WE SWITCHED IT OUT TO A NEW SET & THERE WAS NO ISSUE¿. I DO NOT HAVE THIS EXACT PRODUCT SAVED, BUT THE UNIT EDUCATOR DID GRAB A PRODUCT FROM THE SHELF THAT DAY & SAVED IT- SO IT WOULD PROBABLY BE THE SAME BATCH. THAT LOT #(10)23075418.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545908 ↗
• MalfunctionJan 18, 2024False Alarm; Air/Gas in Device; False Alarm; Air/Gas in Device

  MATERIAL #: 10015414, BATCH#: 23105526. NO ADDITIONAL INFO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18537879 ↗
• MalfunctionJan 2, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL#: 10015414, BATCH NUMBER#: 23085527. CUSTOMER RESPONSE: THE INCIDENT WAS IDENTIFIED AFTER THE INFUSION HAD ALREADY BEGUN. WE RUN THE BLOOD INITIALLY AS A TEST DOSE OVER 15 MINUTES AT A LOW RATE. AFTER THE 15-MINUTE TEST DOSE HAD COMPLETED, I WENT TO CHECK THE LINE AND SQUEEZE MORE BLOOD INTO THE DRIP CHAMBER AND AS SOON AS I TOUCHED THE DRIP CHAMBER THE TUBING DISCONNECTED FROM THE DRIP CHAMBER AND BLOOD LEAKED OUT ONTO THE FLOOR AND ONTO MYSELF. I HOPE THIS HELPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18423455 ↗
• MalfunctionJun 5, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 32 BD ALARIS PUMP MODULE BLOOD SET EXPERIENCED FOREIGN MATTER IN FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING HAS TURNED A BROWN COLOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17061092 ↗
• MalfunctionJun 1, 2023Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE BLOOD SET TUBING WAS DAMAGE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT DETAILS: WAS PREPARING TO ADMINISTER 1 UNIT PRBC'S TO MY PATIENT. UPON INITIATING THE TRANSFUSION NOTICED THE BLOOD PRODUCT WAS LEAKING OUT OF THE INFUSION TUBING ABOVE THE DRIP CHAMBER. CLEANED SAME TOP OFF UNSURE WHERE THE LEAKAGE WAS COMING FROM, UPON FURTHER INVESTIGATION THE TUBING WAS MALFUNCTIONING WHERE THE TUBING CONNECTS TO THE TOP OF THE DRIP CHAMBER. PAUSED TRANSFUSION TO CHANGE TUBING TO A NEW SET. NEW SET WORKING WELL. PATIENT APPEARS TO HAVE NO HARM DURING SAME. IMPACT OF INCIDENT: PAUSED TRANSFUSION TO CHANGE TUBING TO A NEW SET. PATIENT APPEARS TO HAVE NO HARM DURING SAME. WHO WAS AFFECTED? PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17044007 ↗
• MalfunctionJan 4, 2023Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD ALARIS¿ LVP BLD180M 15D DEHP EXPERIENCED COMPONENT SEPARATION, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS A TUBING SEPARATION AT THE DRIP CHAMBER WITH BLOOD TUBING. IT WAS NOTED TO BE DRIPPING BUT NOT ¿COMPLETELY SEPARATED¿. THE IV SET WAS CHANGED OUT. THIS IS THE FIRST TIME IT HAS OCCURRED WITH BLOOD TUBING. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16099611 ↗
• MalfunctionDec 29, 2022Backflow; Backflow

  IT WAS REPORTED WHILE USING BD ALARIS¿ LVP BLD180M 15D DEHP BLOOD BACKFLOWED WHEN THE CLAMP DID NOT HOLD APPROPRIATELY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD FROM PRBC FOUND TO HAVE BACK FLOWED INTO THE SALINE BAG DESPITE BEING CLAMPED APPROPRIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16065720 ↗
• MalfunctionDec 21, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ LVP BLD180M 15D DEHP EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING LEAKED FROM THE FILTER CHAMBER - JUST WHERE THE IV TUBING CONNECTS TO THE FILTER. INFUSION STOPPED, AND NEW TUBING HAD TO BE PRIMED AND USED FOR THE TRANSFUSION TO CONTINUE. HOW LONG WAS PRODUCT IN USE WHEN THE PROBLEM OCCURRED? 5 MIN. HOW WAS IT DETECTED? BLOOD WAS LEAKING AT DRIP CHAMBER ONTO FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16020118 ↗
• MalfunctionSep 8, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD GEM NV BLD 15DP W/180 FLTR LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN DID THE INCIDENT OCCUR? (B)(6) 2022 AT COMPLETION OF BLOOD TRANSFUSION, DRY BLOOD NOTED TO BE NEAR THE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375996 ↗
• MalfunctionSep 8, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BLOOD LEAKED FROM THE BD ALARIS¿ PUMP MODULE BLOOD SET NEAR THE DRIP CHAMBER DURING THE TRANSFUSION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AT COMPLETION OF BLOOD TRANSFUSION, DRY BLOOD NOTED TO BE NEAR THE DRIP CHAMBER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375940 ↗
• MalfunctionSep 7, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ LVP BLD180M 15D DEHP LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT COMPLETION OF BLOOD TRANSFUSION, DRY BLOOD NOTED TO BE NEAR THE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374647 ↗