INFUSOMAT ®

Report

Report Number: 9610825-2023-00693
Event Type: Death
Date Received: January 16, 2024
Date of Event: December 17, 2023
Report Date: January 16, 2024
Manufacturer: B BRAUN MELSUNGEN AG
Product Code: FRN
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CI
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). 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. 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: 16725. 2.6 FURTHER INFORMATION: N/A. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE DEVICE HISTORY FILES FROM 2023-12-17 WERE INVESTIGATED. A SPACE LINE WAS SELECTED AND THE INFUSION STARTED WITH A RATE OF 3,28ML/H AND A VOLUME OF 250ML AT 13:04PM. BETWEEN 14:43PM AND 14:47PM THE INFUSION WAS INTERRUPTED THREE TIMES AND CONTINUED. AT 14:53PM AND 14:54PM THE PRESSURE ALARM OCCURRED, TWO TIMES (PRESSURE LEVEL 9). THE REASON FOR THE ALARM COULD NOT BE CLARIFIED. THE INFUSION WAS CONTINUED AND 20 MINUTES LATER AT 15:15PM THE INFUSION STOPPED AND THE LINE WAS EXTRACTED. NO OTHER ABNORMALITIES WERE FOUND. 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 IS SLIGHTLY DIRTY BUT NO VISIBLE DAMAGE WERE FOUND. 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. 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 +1,24%. ((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. IT COULD BE FOUND LIQUID RESIDUES ON THE LOWER HOUSING, THE EMC PROTECTION SHIELD, THE BOTTOM INNER FRAME AND THE BATTERY. 4. JUDGMENT: 4.1 ON THE DAY OF OCCURRENCE COULD BE FOUND TWO PRESSURE ALARMS IN THE DEVICE HISTORY DURING THE INFUSION. THE REASON FOR THE PRESSURE ALARMS COULD NOT BE CLARIFIED. THE DEVICE WAS INVESTIGATED. DURING THE INVESTIGATION NO MALFUNCTION COULD BE DETECTED.

Description of Event or Problem · 0

AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN CHILE: "INFUSION PUMP NOT WORKING." ACCORDING TO THE COMPLAINANT, A PATIENT WAS ADMITTED ON (B)(6) 2023 AT 11 AM IN SEVERE CONDITION. THE PATIENT WAS INTUBATED AND REQUIRED A VASOACTIVE DRUG. AT 14:50 PM, CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. AT THIS TIME, THE NORADRENALINE INFUSION PUMP WAS FOUND TO BE DYSFUNCTIONAL. A PUMP CHANGE WAS PERFORMED, HOWEVER, THE PATIENT SUBSEQUENTLY DIED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1653401	INFUSOMAT ®	PUMP, INFUSION	FRN	B BRAUN MELSUNGEN AG	8713050

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Death