Infusomat® 8713060URecalls & reported problems
B. Braun Medical Inc. · INFUSOMAT SPACE ACM-KIT · Class 2
All models of Infusomat (54)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963687199), received between Oct 25, 2017 and May 13, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Flow or Under Infusion3
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Insufficient Flow or Under Infusion
AS REPORTED BY THE USER FACILITY: ACCORDING TO THE COMPLAINANT, THE INFUSION PUMP WAS PUMPING SLOWER THAN THE PROGRAMMED INFUSION RATE. AS A RESULT, THE MEDICATION DID NOT COMPLETE INFUSING TO THE PATIENT WITHIN THE INTENDED AMOUNT OF TIME. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162698 ↗MalfunctionOct 25, 2017Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
AS REPORTED BY USER FACILITY: GAMMAGAURD WAS SET TO INFUSE IN 2 HOURS, BUT THE INFUSION TOOK 5 HOURS. THE CUSTOMER SAID THIS HAS HAPPENED MORE THAN ONCE, BUT DID NOT HAVE ANY ADDITIONAL DETAILS. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6977636 ↗MalfunctionOct 25, 2017Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
AS REPORTED BY USER FACILITY: A 100 ML BAG WAS SET TO INFUSE OVER 1 HOUR, BUT THE INFUSION TOOK MORE THAN 1.5 HOURS. LIMITED INFORMATION PROVIDED; THE DRUG USED WAS UNKNOWN. THE CUSTOMER INDICATED THAT THIS HAS HAPPENED MORE THAN ONCE, BUT DID NOT HAVE ANY ADDITIONAL DETAILS. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6977630 ↗
Other Pump, infusion devices
- Alaris 8100Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths650,218 reports
- Alaris 8100Carefusion 303, Inc. · Pump, infusion4 recalls78 deaths344,514 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion2 recalls45 deaths148,093 reports
- BD® Alaris™ Pump Module, Model 8100Carefusion 303, Inc. · Pump, infusion5 recalls30 deaths51,256 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls4 deaths21,956 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths15,547 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion3 recalls6 deaths13,022 reports
- CADD 21-6500-51Icu Medical, Inc. · Pump, infusion2 deaths8,231 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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