INFUSOMAT SPACE
Report
- Report Number
- 9610825-2022-00124
- Event Type
- Malfunction
- Date Received
- April 8, 2022
- Date of Event
- March 8, 2022
- Report Date
- July 6, 2022
- Manufacturer
- B.BRAUN MELSUNGEN AG
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. 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.
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE HAS BEEN INVESTIGATED IN OUR SERVICE DEPARTMENT AT B. BRAUN MELSUNGEN AG, MELSUNGEN, GERMANY: 2. RESULTS: 2.1 A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS AND THE PRODUCTION SEAL ON THE LOWER HOUSING WERE INTACT. 2.2 A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED THE SELF-TEST. A SPACE LINE WAS INSERTED, THE PUMP IDENTIFIED THE LINE, AND IT COULD BE SELECTED FROM THE MENU. IT WAS POSSIBLE TO PUT THE PUMP IN OPERATION. 2.3 THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. THE HISTORY FILES FROM 2022-03-08 WAS INVESTIGATED. AT 15:28 P.M. A SPACE LINE WAS INSERTED. AT 15:30 P.M. THE RATE WAS SET TO 1200 ML/H AND THE VTBI (VOLUME) WAS SET TO 250 ML. A FEW SECONDS LATER THE INFUSION WAS STARTED BY THE CUSTOMER. AT 15:56 P.M. THE INFUSION WAS STOPPED THE FIRST TIME BECAUSE THE VTBI (VOLUME) WAS REACHED (THE VALUES HAVE REACHED THE SET TARGETS CORRECTLY). THE VTBI WAS SET SEVERAL TIMES TO 250 ML AND THE INFUSION WAS STARTED AGAIN (THE VALUES HAVE REACHED THE SET TARGETS CORRECTLY EVERY TIME). AT 20:03 P.M. AN "UPSTREAM ALARM" DISPLAYED. THE REASON FOR THIS ALARM COULD NOT CLARIFIED. SUCH AN ALARM COULD, FOR EXAMPLE, BE PROVOKED BY A CLOSED ROLLER CLAMP. THE HISTORY DOES NOT SHOW ANY ANOMALIES. 2.4 THE DOWNSTREAM SENSOR, THE ELECTRONIC PRESSURE CUT-OFF AND THE MECHANICAL PRESSURE LIMITATION OF THE DEVICE WERE TESTED ACCORDING TO THE REQUIREMENTS OF THE TECHNICAL SAFETY CHECK. FURTHERMORE, THE PRESSURE STABILITY OF THE SAFETY CLAMP CONCERNING THE PERCOLATION (FREE FLOW POSSIBILITY) WAS CHECKED. THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. 2.5 A DELIVERY ACCURACY MEASUREMENT ACCORDING TO IEC 60601-2-24 WAS ARRANGED. HERE A NOMINAL FEED RATE OF 100 ML/H WAS CHOSEN. THE ASSESSED MEAN DEVIATION "A" OF THE SECOND OPERATING HOUR WAS MEASURED AND RESULTED IN A VALUE OF -2,37%. (ACCURACY OF SET DELIVERY RATE SHOULD BE: ± 5 % ACCORDING TO IEC/EN 60601-2-24) THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. 2.6 DURING THE INVESTIGATION NO FAULTS COULD BE DETECTED. TO INVESTIGATE THE INSIDE OF THE DEVICE, ONLY THE UPPER HOUSING WAS REMOVED. NO DAMAGE OR SOILING COULD BE FOUND. 3. JUDGMENT: THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATES WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION.
AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6): "UNDER INFUSION". "WE ARE HAVING AN ISSUE WITH ONE OF THE INFUSORS S/N 812197. WE WERE ADMINISTERING BOLUS DOSES AND AFTER 750ML VOLUME INFUSED WE NOTICED THE BAG WAS ALMOST FULL. THERE WERE DROPS COMING THROUGH THE CHAMBER BUT IT WAS NOT AS FAST AS WHEN CHANGED TO ANOTHER INFUSOR. WE ARE AWARE OF THE PRODUCT ALERT BUT THIS WAS NOT ONE OF THE LISTED ITEM NOR THE TYPE OF DEVICE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1110809 | INFUSOMAT SPACE | PUMP, INFUSION, | FRN | B.BRAUN MELSUNGEN AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |