INFUSOMAT SPACE
Report
- Report Number
- 9610825-2023-00322
- Event Type
- Malfunction
- Date Received
- July 7, 2023
- Report Date
- October 19, 2023
- Manufacturer
- B.BRAUN MELSUNGEN AG
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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: N030004. 2.5 HOURS OF OPERATION: 20583 HOURS. 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 FROM THE COSTUMER. THEREFORE, THE LAST HISTORY FILES FROM 2023-05-25 TO 2023-05-29 WERE INVESTIGATED. AT 2023-05-29 07:21 AM A SPACE LINE WAS INSERTED. THE RATE WAS SET TO 200 ML/H AND THE VTBI TO 100 ML. IN THE SAME MINUTE THE INFUSION WAS STARTED. AT 07:49 "VTBI NEAR END" WAS DISPLAYED. THE INFUSION WAS STOPPED BY THE CUSTOMER AT 07:50 AM. THE DEVICE FIT THE SET VALUES FROM THE CUSTOMER. NO ANOMALIES COULD BE DETECTED IN THE HISTORY FILES. 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 SHOWS SOME LIQUID RESIDUES AT THE OUTSIDE BUT NO VISUAL DAMAGED PART. 3.3 FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSES 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: IN 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 (B)(6) WAS CHOSEN. THE ASSESSED AVERAGE DEVIATION "A" OF THE SECOND OPERATING HOUR WAS MEASURED AND RESULTED IN A VALUE OF -0,08%. ((ACCURACY OF SET DELIVERY RATE SHOULD BE: (B)(6) 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. THE COMPLAINT MALFUNCTION COULD NEITHER BE REPRODUCED NOR DETECTED INSIDE THE HISTORY FILES. 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 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.
AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN IRELAND: "UNDERINFUSION" ACCORDING TO THE CUSTOMER: REPORTED AS NOT INFUSING CORRECTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2014616 | INFUSOMAT SPACE | PUMP, INFUSION | FRN | B.BRAUN MELSUNGEN AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |