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 02/09/2024

Event Type  malfunction  

Event Description

According to the customer: "500ml of 0.9% nacl with magnesium sulphate 2.5mls was started on (b)(6) 2024 at 1432hrs, connecting to patient's central line.User shared that she selected 0.9% nacl from the drug library, as drug library did not have fluids with additives.She then proceeded to set vtbi at 500ml with an infusion rate of 251ml/hr.A new infusion 8700036sp was used for the therapy.According to the staff at approximately 1530hrs, air bubble alarm was triggered on the pump and the patient notified the staff nurse in charge.500ml of 0.9% nacl with magnesium sulphate 2.5mls was started on (b)(6) 2024 at 1432hrs, connecting to patient's central line.User shared that she selected 0.9% nacl from the drug library, as drug library did not have fluids with additives.She then proceeded to set vtbi at 500ml with an infusion rate of 251ml/hr.A new infusion 8700036sp was used for the therapy.".

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.

Manufacturer Narrative

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)(4) 2.4 software version: m030003 2.5 hours of operation: 37961 3.Investigation results: 3.1 history inspection: the device history files were read and analyzed.The device history files from 2024-02-09 were investigated.A rate of 251 ml/h and a volume of 490ml was selected.The infusion started and the upstream alarm occurred directly.The roller clamp was closed.The infusion was continued.1 hour later the a "air rate alarm" occurred and the infusion was stopped.At this time, 219,9ml was infused.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 was slightly dirty but no visible damage 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.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 -0,08%.((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.Inside the device was slightly dirty but no visible damage was found inside the device.4.Judgment: 4.1 the complaint could not be confirmed.Summing up all tests, the infusomat space operates within our specification.No product deviation.Please kindly inform your customer.

• 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: 18882121
• MDR Text Key: 337849627
• Report Number: 9610825-2024-00175
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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