MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG INFUSOMAT ®; PUMP, INFUSION

Model Number 8713050

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2024

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).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.

Event Description

As reported by the user facility information by bbm sales organization in ireland: "underinfusion - blood." according to the customer: "renal cell carcinoma (rcc) 264 milliliters (ml) total unit volume set to infuse.Pump alarmed to say volume infused (delta volume 246 milliliters (mls) however noticed 200 milliliters (mls) remained in bag.Giving set and pump changed and rest of volume given.Issue occurred: 14/01/2024 in picu.No patient harm mentioned.".

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number 400639269.1.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)(4) 2.4 software version: n030005 2.5 hours of operation: 13926 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 (b)(6) 2024 were investigated.A space line was selected and the infusion started with a rate of 88ml/h and a volume of 264ml about 4 hours.The infusion started and the upstream alarm occurred (roller clamp was closed).The infusion was continued and at the beginning, the pressure alarm occurred 6 times.The reason for the alarms could not be clarified.The alarm was confirmed and the infusion could be started.The volume was reached and the infusion was stopped.At this time, 264ml was infused.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 in a clean state but a damage on the operating unit was 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: pressure stage 2: is: 0,42 bar (should be: 0,1-0,7 bar) pressure stage 9: is: 1,07 bar (should be: 0,8-1,4 bar) the mechanical pressure cut-off was checked: pmax: is: 2,13 bar (should be: 1,8-2,5 bar) pmin: is: 1,76 bar (should be: >1,5 bar) safety clamp was checked: pmin: is: 2,03 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 -2,13%.((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.Additional to the damage operating unit, could be found a damage on the pump frame.3.7 test equipment: description: typ nr.: lab.-id.-nr.Sika mh3151 qf04198 3.8 for examination used disposables: description: ref.: lot: infusomat space line 8700036sp 24a23e8st1 4.Judgment: 4.1 the complaint could not be confirmed.Summing up all tests, the infusomat space operates within our specification.No product deviation.The damage parts, a damage because of an impact damage.Addition information: 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.

• Brand Name: INFUSOMAT ®
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18737760
• MDR Text Key: 335735659
• Report Number: 9610825-2024-00089
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8713050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1