SPECTRUM WITH MDL 35700BAXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2,077 adverse event reports that list this exact device (DI 00085412091570), received between Jan 3, 2018 and Aug 25, 2026 — classified as 1 death, 7 injuries, 2,069 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (774 reports).

6 FDA recall records name this device's identifier, 4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 20, 2025Class IOpen, Classified

   Certain Spectrum infusion pumps may have an incorrect version of software.

   Z-2095-2025 · Root cause: Employee error · Recall details · FDA record ↗

2. Feb 5, 2025Class IOpen, Classified

   There is the potential for missing motor mounting screws, which may have occurred during the servicing process.

   Z-1253-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Nov 19, 2024Class IIOpen, Classified

   Devices were identified as released after repair without full testing being performed, which includes flow testing.

   Z-0775-2025 · Root cause: Process control · Recall details · FDA record ↗

4. Nov 23, 2020Class IIOpen, Classified

   There is a potential software error during programming.

   Z-0712-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Jun 30, 2020Class ITerminated

   Baxter is updating the device IFU for safety communication regarding cleaning practices.

   Z-0120-2021 · Root cause: Labeling design · Recall details · FDA record ↗

6. Jun 30, 2020Class ITerminated

   Baxter is updating the device IFU for safety communication regarding cleaning practices.

   Z-0121-2021 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 2,077 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Filling Problem

  It was reported that a Spectrum Infusion Pump overinfused Oxytocin. The Oxytocin was supplied in a 500 mL bag. The patient reportedly began experiencing contractions almost immediately after the pump was started at the lowest setting, and rapid contractions recurred after the infusion was restarted. No additional information is available.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50434835 ↗
• MalfunctionAug 18, 2026False Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50309256 ↗
• InjuryAug 18, 2026Filling Problem

  It was reported thta a SIGMA Spectrum Infusion Pump overinfused a fentanyl infusion in the Intensive Care Unit (ICU). The fentanyl infusion, with a concentration of 1000 mcg/100 mL, was programmed with a volume to be infused (VTBI) of 88mL at a rate of 5 mL/hour. The reporter stated that fentanyl infusion bags, which were expected to last approximately 16 to 18 hours, reportedly emptied within 2 to 4 hours. The patient reportedly exhibited possible signs of overinfusion. No additional information is available.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50307917 ↗
• InjuryAug 18, 2026Filling Problem

  It was reported thta a SIGMA Spectrum Infusion Pump overinfused a fentanyl infusion in the Intensive Care Unit (ICU). The fentanyl infusion, with a concentration of 1000 mcg/100 mL, was programmed with a volume to be infused (VTBI) of 80 mL. The reporter stated that fentanyl infusion bags, which were expected to last approximately 16 to 18 hours, reportedly emptied within 2 to 4 hours. The patient reportedly exhibited possible signs of overinfusion. No additional information is available.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50305869 ↗
• MalfunctionAug 17, 2026Filling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50279545 ↗
• MalfunctionAug 14, 2026False Alarm; Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260178 ↗
• MalfunctionMay 5, 2026Defective Alarm

  IT WAS REPORTED THAT A SPECTRUM INFUSION PUMP FAILED DOWNSTREAM (DISTAL) OCCLUSION SENSOR TEST WITH VALUES OF 22.25 AND 20.86 PSI (POUNDS PER SQUARE INCH). THIS OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081145 ↗
• MalfunctionApr 24, 2026Protective Measures Problem

  IT WAS REPORTED THAT A SPECTRUM PUMP ALARMED SYSTEM ERROR 322 (LINK SWITCH ERROR (LOW)) DURING PROGRAMMING /SET UP IN THE BIOMEDICAL SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24983735 ↗
• MalfunctionApr 21, 2026False Alarm; Filling Problem

  IT WAS REPORTED THAT A SPECTRUM INFUSION PUMP INADVERTENTLY ADMINISTERED THE ENTIRE INFUSION OF AMIODARONE AND NOT THE SET AMOUNT THAT WAS PROGRAMMED DURING A BOLUS INFUSION DURING DELIVERY IN INTENSIVE CORONARY CARE UNIT (ICCU). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945550 ↗
• MalfunctionApr 7, 2026Failure to Sense

  IT WAS REPORTED THAT A SPECTRUM PUMP FAILED TO ALARM AN UPSTREAM OCCLUSION DURING PATIENT INFUSION AT INTENSIVE CARE UNIT DEPARTMENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811006 ↗
• MalfunctionMar 24, 2026Defective Alarm

  IT WAS REPORTED THAT A SPECTRUM PUMP FAILED DOWNSTREAM OCCLUSION TEST. THIS OCCURRED DURING PREVENTIVE MAINTENANCE TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674269 ↗
• MalfunctionMar 23, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT A SPECTRUM INFUSION PUMP OVER-INFUSED FENTANYL DURING DELIVERY, INFUSION ENDED EARLY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670021 ↗
• MalfunctionMar 23, 2026Defective Alarm

  IT WAS REPORTED THAT A SPECTRUM PUMP FAILED THE DOWNSTREAM OCCLUSION TEST (AT HIGH PRESSURE SETTING). IT WAS FURTHER REPORTED THAT THE DOWNSTREAM PRESSURE READING AT THE TIME OF DOWNSTREAM OCCLUSION ALARM WAS 1175ML (HOWEVER THIS IS NOT A PRESSURE READING). THIS OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24669768 ↗
• MalfunctionMar 23, 2026False Alarm

  IT WAS REPORTED THAT A SPECTRUM PUMP HAD NUISANCE DOWNSTREAM OCCLUSION ALARM. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663400 ↗
• MalfunctionFeb 27, 2026Filling Problem

  IT WAS REPORTED THAT A SPECTRUM PUMP WASN'T PASSING THE HIGH END TEST. THIS WAS FURTHER DESCRIBED AS THEY WERE TESTING FOR VOLUME OUTPUT WITH PARAMETERS SET TO 800 ML AND 200 ML FOR THE HIGH END, AND 10 ML AND 40 ML FOR THE LOW END. THE PUMP UNDER-DELIVERED ON THE ALLOTTED AMOUNT FOR THE HIGH END. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471363 ↗
• MalfunctionFeb 26, 2026False Alarm

  IT WAS REPORTED THAT A SPECTRUM PUMP REPEATEDLY INDICATED ¿AIR IN LINE¿ IN LOCATION 1, DESPITE NO AIR BEING FOUND. THE LINE WAS REPLACED WITH A NEW SET, BUT THE ALARM CONTINUED AND THE ERROR COULD NOT BE CLEARED. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455714 ↗
• MalfunctionFeb 18, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT A SPECTRUM INFUSION PUMP OVER-INFUSED AN UNSPECIFIED MEDICATION DURING DELIVERY TO A PATIENT. THIS WAS FURTHER DESCRIBED AS "QUANTITY OF FLUIDS INFUSING DID NOT MATCH THE PUMP SETTING (75ML/HR). PATIENT WAS RECEIVING MORE FLUIDS THAN WAS INTENDED". THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376684 ↗
• MalfunctionFeb 16, 2026False Alarm

  IT WAS REPORTED THAT A SPECTRUM INFUSION PUMP DISPLAYED AN AIR-IN-LINE ALARM DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343434 ↗
• MalfunctionFeb 16, 2026False Alarm

  IT WAS REPORTED THAT A SPECTRUM PUMP ALARMED AIR IN LINE DURING AN UNSPECIFIED PROCESS STEP IN THE BIOMED SERVICE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342534 ↗
• MalfunctionFeb 13, 2026Defective Alarm

  IT WAS REPORTED THAT A SPECTRUM INFUSION PUMP DISPLAYED AN UNDEFINED ISSUE OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337242 ↗
• MalfunctionFeb 11, 2026Failure to Sense; Complete Loss of Power

  IT WAS REPORTED THAT A SPECTRUM PUMP POWERED OFF WITHOUT USER INPUT AND FREEZES ON CLOSED DOOR WHEN TUBE US LOADED DURING AN UNSPECIFIED PROCESS STEP IN THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24319075 ↗
• MalfunctionFeb 9, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT A SPECTRUM INFUSION PUMP OVER-INFUSED INFLECTRA DURING PATIENT INFUSION. THE PATIENT INFUSION TAKES AROUND 2 HOURS BUT THE INFUSION WAS COMPLETED IN 1 HOUR AND 28 MINUTES. PATIENT RECEIVED 405MG OF INFLECTRA BASED ON HER BODY WEIGHT FOR THE DAYS VISIT TO THE CLINIC. THE MEDICATION WAS RECONSTITUTED WITH 10MLS OF STERILE WATER AND FIVE VIALS WERE USED. A 250ML BAG WAS USED TO MIX MEDICATION WITH 40.5MLS REMOVED FROM THE BAG AND 40.5MLS OF MEDICATION ADDED TO THE BAG. THE PUMP WAS SET AT 125MLS/HR FOR A 250ML BAG. THE TOTAL TIME OF INFUSION TOOK 1 HOUR AND 28MINS. THE PATIENT DID NOT REPORT ANY REACTIONS AT THE END OF THE INFUSION AND STAYED IN THE CLINIC FOR A 15 MINUTE MONITORING PERIOD. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291684 ↗
• MalfunctionFeb 3, 2026Protective Measures Problem

  IT WAS REPORTED THAT A SPECTRUM INFUSION PUMP ALARMED SYSTEM ERROR 322 (LINK SWITCH ERROR (LOW)) DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24249067 ↗
• MalfunctionFeb 3, 2026Complete Loss of Power

  IT WAS REPORTED THAT A SPECTRUM INFUSION PUMP WAS INFUSING INTRAVENOUS IMMUNOGLOBULIN (IVIG) AND STOPPED RUNNING AND IMPROPERLY SHUTDOWN DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248564 ↗
• MalfunctionFeb 3, 2026Protective Measures Problem

  IT WAS REPORTED THAT A SPECTRUM INFUSION PUMP ALARMED SYSTEM ERROR 345 (THERMISTOR DISPARITY) DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246819 ↗