PERFUSOR SPACE
Report
- Report Number
- 9610825-2022-00378
- Event Type
- Malfunction
- Date Received
- September 16, 2022
- Report Date
- August 8, 2023
- 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 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: GENERAL INFORMATION: COMPLAINT: (B)(4). 2. INFORMATION TO THE SAMPLE: 2.1 MODEL: PERFUSOR SPACE; 2.2 ARTICLE NUMBER: (B)(4); 2.3 SERIAL NUMBER/BATCH: (B)(6); 2.4 SOFTWARE VERSION: N030004; 2.5 HOURS OF OPERATION: 42819 H; 2.6 FURTHER INFORMATION: N/A. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. AS NO DATE OF THE INCIDENT WAS GIVEN, FOR THAT REASON THE LAST HISTORY FILES FROM (B)(6) 2022 TO (B)(6) 2022 WERE INVESTIGATED. IT COULD BE DETECTED THAT THE DEVICE WAS USED WITH A DRUGLIB NAMED "(B)(6) 2017_BDM RéA-". FURTHERMORE, THERE ARE NO ANOMALIES INSIDE THE HISTORY FILES. 3.2 VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS WERE INTACT AND UNDAMAGED. THE DEVICE SHOWS AGED, RELATED SIGNS OF WEAR AND TEAR. FURTHERMORE, MANY LIQUID RESIDUES AT THE OUTSIDE COULD BE DETECTED. IN ADDITION, NO MORE ANOMALIES COULD BE DETECTED. 3.3 FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED THE SELF-TEST. A BD PLASTIPAK 50/ML SYRINGE WAS INSERTED, THE PUMP IDENTIFIED THE SYRINGE, AND IT COULD BE SELECTED FROM THE MENU. IT WAS POSSIBLE TO PUT THE PUMP IN OPERATION. 3.4 INDIVIDUAL INSPECTION: A DELIVERY ACCURACY MEASUREMENT ACCORDING TO IEC 60601-2-24 WAS ARRANGED. HERE A NOMINAL FLOW RATE OF 5 ML/H WAS CHOSEN. THE ASSESSED MEAN DEVIATION "A" OF THE SECOND OPERATING HOUR WAS MEASURED AND RESULTED IN A VALUE OF +0,05%. ACCURACY OF SET DELIVERY RATE SHOULD BE ± 2 % ACCORDING TO IEC/EN 60601-2-24. 3.5 DISASSEMBLING: DURING THE INVESTIGATION FAULTS COULD BE DETECTED, TO INVESTIGATE THE INSIDE, THE DEVICE WAS DISASSEMBLED COMPLETE. LIQUID RESIDES INSIDE THE OPERATING UNIT AT THE CONTACTS COULD BE FOUND. FURTHERMORE, THE UPPER HOUSING AND LOWER HOUSING PARTS SHOWS BROKEN PARTS. IN ADDITION, THE DRIVE HEAD IS DAMAGED AND SHOWS BROKEN PARTS, FURTHERMORE THE DRIVE SHOWS BROKEN PARTS. THE P2 CONNECTOR IS DEFORMED. FURTHERMORE, THERE ARE NO ANOMALIES INSIDE THE DEVICE. THE DAMAGED PARTS IDENTIFY AN EXTERNAL FORCE AND LIQUID DAMAGE. 4. JUDGMENT: 4.1 THE COMPLAINT COULD NOT BE CONFIRMED. A FLOWRATE DEVIATION COULD NOT BE DETECTED. THE BROKEN PARTS ARE DUE TO AN EXTERNAL FORCE DAMAGE. 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. "DYSFONCTIONAL PSE DUE TO TENSIONAL ISSUES WITH NORADRENALINE OF THE PATIENT. AT TIMES RECEIVED TOO MUCH OR NOT ENOUGH - CHECKED AFTER RELAY STABLE PATIENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125726 | PERFUSOR SPACE | PUMP, INFUSION | FRN | B.BRAUN MELSUNGEN AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |