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

Catalog Number 8713050

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 02/26/2023

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (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 france: "overinfusion".According to the customer: chimio placed at 22h30 with the right programming; chimio infused in 4 h instead of 20h; the device displayed that there is still 16h but the bag was already empty.Incident during the night of the 26/27 february - start of the therapy: 22h30 (26/02) - the patient at 2h am (27/02) the infusion was finished.

Manufacturer Narrative

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: 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: 5972 2.6 further information: n/a ---------------------------------------------------------------- 3.Investigation results: 3.1 history inspection: the device history files were read out and analyzed.The infusion was started on 2023-02-26 at 23:23 with a rate of 5,2 ml/h and a volume of 104ml.On the next day at 02:49 the infusion stopped by an air rate alarm.The reason the alarm could not be clarified.At this time, 17,86ml 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 is in a clean state and no visible damage are to locate.3.3 functional inspection: a functional test was performed.The device passed 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 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 -4,18%.The 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: during the investigation no faults could be detected.To investigate the inside of the device, only the upper housing was removed.No damage or soiling could be found.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.

• Brand Name: INFUSOMAT SPACE
• Type of Device: PUMP, INFUSION,
• Manufacturer (Section D): B.BRAUN MELSUNGEN AG; carl- braun strasse 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B.BRAUN MELSUNGEN AG; carl-braun strasse 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16811744
• MDR Text Key: 313997560
• Report Number: 9610825-2023-00172
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 8713050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1