INFUSOMAT®
Report
- Report Number
- 9610825-2026-00165
- Event Type
- Malfunction
- Date Received
- April 2, 2026
- Report Date
- April 13, 2026
- Manufacturer
- B BRAUN MELSUNGEN AG
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4). PREMARKET SUBMISSION # K083689, K142596, K191910.
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). SAMPLE INFORMATION: INFUSOMAT SPACE, 8713050, SERIAL NO.: (B)(6). HISTORY FILES: ON 03/09/2026, THE FLOW RATE WAS PROGRAMMED AT 4.4 ML/H AND THE VOLUME OF 105 ML WAS CHOSEN, AS REPORTED BY THE USER. THE USER STARTED THE INFUSION ON 03/09/2026, AT 6:01:11PM AND FINISHED THE INFUSION ON 03/10/2026, AT 4:00:52PM. IT WAS THE USER WHO DECIDED TO END THE INFUSION BY ACTIVATING THE STANDBY FUNCTION AT 4:00:52 PM. THE TOTAL VOLUME INFUSED AT THAT TIME WAS 113.24 ML. TOTAL VOLUME INFUSED: 95.6 ML, EXCLUDING THE AMOUNT NOT ZEROED OUT. TOTAL INFUSION TIME: 21H43MIN49. VISUAL INSPECTION: THE EQUIPMENT HAS A NORMAL USED APPEARANCE. FUNCTIONAL INSPECTION: AN INFUSION WAS PERFORMED USING THE USER-DEFINED SCHEDULE THAT WAS IN USE AT THE TIME OF THE ADVERSE EVENT. THE PROGRAMMED VOLUME WAS 105 ML, WITH A PROGRAMMED FLOW RATE OF 4.4 ML/H, IN 23H52MIN. THE VOLUME INFUSED WAS 106 ML WITH AN ERROR OF +1.0% AND THE INFUSION TIME WAS 23H54MIN54 WITH AN ERROR OF +0.2%. THE TEST WAS APPROVED (SYSTEM ACCURACY IS TYPICALLY ±5% OF VOLUME, ACCORDING TO IEC/EN 60601-2-24). CONCLUSION: THE TECHNICAL DEFECT COULD NOT BE CONFIRMED. THE ANALYSIS OF THE USAGE HISTORY SHOWED THAT THE EQUIPMENT FUNCTIONED CORRECTLY ON THE DATE OF THE ADVERSE EVENT. NO ERROR IN INFUSED VOLUME OR INFUSION TIME WAS RECORDED. THE INFUSION ENDED BEFORE THE PROGRAMMED TIME DUE TO A DECISION BY THE USER WHO ACTIVATED THE STANDBY FUNCTION. THE FUNCTIONAL TEST RESULT SHOWED THAT THE EQUIPMENT IS FUNCTIONING PRECISELY ACCORDING TO ITS TECHNICAL SPECIFICATION. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.
ACCORDING TO THE EVENT DESCRIPTION: NURSING STAFF REPORTED THAT THE PATIENT WAS RECEIVING A CONTINUOUS INFUSION VIA MESANA INFUSION PUMP AT 4.4 ML/H, SCHEDULED TO END AT 5:55 PM, AS INSTALLED AND PROGRAMMED BY NURSE VANESSA FROM CHEMOTHERAPY. MEDICATIONS WERE DISCONTINUED 4 HOURS EARLY. IS THIS A TECHNOVIGILANCE ERROR, OPERATIONAL ERROR, OR MALFUNCTION PLEASE VERIFY THE EQUIPMENT'S FUNCTIONALITY. THE GENERAL ICU SDJ NURSE IDENTIFIED THE TERMINATION OF A 24-HOUR CONTINUOUS INFUSION VIA BIC TWO HOURS EARLIER THAN SCHEDULED, AS PER THE PRESCRIBED MEDICAL PRESCRIPTION. THE PHARMACIST NOTED THAT THERE WAS NO INDICATION OF ANY HARM TO THE PATIENT DUE TO THE PRESCRIBED DOSAGE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227685 | INFUSOMAT® | PUMP, INFUSION | FRN | B BRAUN MELSUNGEN AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |