INFUSOMAT SPACE
Report
- Report Number
- 9610825-2022-00450
- Event Type
- Malfunction
- Date Received
- November 1, 2022
- Report Date
- August 4, 2023
- Manufacturer
- B.BRAUN MELSUNGEN AG
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT 400571793: 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: 1. GENERAL INFORMATION: COMPLAINT: (B)(4). ---------------------------------------------------------------- 2. INFORMATION TO THE SAMPLE: 2.1 MODEL: INFUSOMAT SPACE. 2.2 ARTICLE NUMBER: 8713050. 2.3 SERIAL NUMBER/BATCH: (B)(6). 2.4 SOFTWARE VERSION: N030005. 2.5 HOURS OF OPERATION: 3585 H. 2.6 FURTHER INFORMATION: N/A. ---------------------------------------------------------------- 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. NO DATE OF THE INCIDENT WAS GIVEN, FOR THAT REASON THE LAST HISTORY FILES WERE INVESTIGATED. MANY UPSTREAM AND AIR ALARMS COULD BE DETECTED. THE REASON FOR THAT COULD NOT BE CLARIFIED. FURTHERMORE, NO ANOMALIES COULD BE DETECTED. DUE TO THE LACK OF A PRECISE ERROR DESCRIPTION, THE HISTORY COULD NOT BE ANALYZED EXTENSIVELY. 3.2 VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE PRODUCTION SEAL ON THE LOWER HOUSING WERE INTACT. THE DEVICE IS IN A CLEAN STATE AND NO VISIBLE DAMAGED ARE TO LOCATE. 3.3 FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED THE SELF-TEST. A SPACE LINE WAS INSERTED, AND THE PUMP IDENTIFIED THE LINE, AND IT COULD BE SELECTED FROM THE MENU. IT WAS POSSIBLE TO PUT THE PUMP IN OPERATION. 3.4 PRESSURE INSPECTION: FOR CHECKING 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. THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. 3.5 FLOW RATE INSPECTION: A DELIVERY ACCURACY MEASUREMENT ACCORDING TO IEC 60601-2-24 WAS ARRANGED. HERE A NOMINAL FLOW 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 (B)(4). THE 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. 3.6 DISASSEMBLING: 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. 4. JUDGMENT: 4.1 THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATES WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION. 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.
AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE: "FLOW RATE DEVIATION." CUSTOMER STATEMENT: "PROBLEM OF FLOW."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458050 | INFUSOMAT SPACE | PUMP, INFUSION, | FRN | B.BRAUN MELSUNGEN AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |