INFUSOMAT®
Report
- Report Number
- 9610825-2024-00644
- Event Type
- Malfunction
- Date Received
- August 15, 2024
- Date of Event
- July 9, 2024
- Report Date
- August 15, 2024
- Manufacturer
- B. BRAUN MELSUNGEN AG
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). 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: 608870. 2.4 SOFTWARE VERSION: N030004. 2.5 HOURS OF OPERATION: 21575. 2.6 FURTHER INFORMATION: N/A. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. NO ABNORMALITIES WERE FOUND IN THE DEVICE AND ALARM HISTORY. 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 AND UNDAMAGED. THE DEVICE SHOWS AGE RELATED SIGNS OF WEAR AND TEAR AND IS PROVIDED WITH LIQUID RESIDUES BUT NO VISIBLE DAMAGE WAS FOUND. A VISUAL INSPECTION REVEALED THAT THE CONTACTS OF THE P2 PLUG ARE MECHANICALLY DAMAGED AND HAVE LIQUID RESIDUE ON THEM. THE RIBBON CABLE FROM THE CONTROL UNIT IS HEAVILY KINKED. 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 ELECTRONIC PRESSURE CUT-OFF WAS CHECKED: PRESSURE STAGE 2: IS: 0,35 BAR (SHOULD BE: 0,1-0,7 BAR). PRESSURE STAGE 9: IS: 1,01 BAR (SHOULD BE: 0,8-1,4 BAR). THE MECHANICAL PRESSURE CUT-OFF WAS CHECKED: PMAX: IS: 1,98 BAR (SHOULD BE: 1,8-2,5 BAR). PMIN: IS: 1,79 BAR (SHOULD BE: >1,5 BAR). SAFETY CLAMP WAS CHECKED:. PMIN: IS: 1,82 BAR (SHOULD BE: >1,2 BAR). 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 AVERAGE DEVIATION "A" OF THE SECOND OPERATING HOUR WAS MEASURED AND RESULTED IN A VALUE OF -0,26%. (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: THE DEVICE WAS DISASSEMBLED AND THE INSIDE WAS INVESTIGATED. NO VISIBLE DAMAGE WERE FOUND INSIDE THE DEVICE BUT A LOT OF LIQUID RESIDUE CAN BE SEEN IN THE LOWER PART OF THE HOUSING. 3.7 TEST EQUIPMENT: DESCRIPTION: SIKA. TYP NR.:MH3151. LAB.-ID.-NR. (B)(6). 3.8 FOR EXAMINATION USED DISPOSABLES: DESCRIPTION: INFUSOMAT SPACE LINE, REF.: 8700036SP, LOT: 24D21E8ST1. 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.
ACCORDING TO THE COMPLAINT DESCRIPTION: FOLLOWING THE FLOW PROBLEMS WE RECENTLY HAD ON 3 PUMPS (SEE PDF IN PJ) THE INFUSION WAS COMPLETED 4H13 EARLY, WITH A REMAINING VOLUME OF 185.9ML; THE FLOW RATE WAS GOOD, BUT THE HYDRATION BAG WAS COMPLETELY EMPTY ( SEE PHOTO). G5 1000ML WITH 4G NACL + 4 AMPOULES ACUPAN /24H.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1176710 | INFUSOMAT® | PUMP, INFUSION | FRN | B. BRAUN MELSUNGEN AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |