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

Catalog Number 8713050

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).3.Investigation results: 3.1 history inspection: the device history files were read and analyzed.Due to the lack of a precise error description, the history could not be analyzed extensively.The last infusions were investigated.No anomalies could be detected.(history files are attached to the pc notification) 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.(pictures are attached to the pc notification) 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: 0,50 bar (should be: 0,1-0,7 bar) pressure stage 9: is: 1,13 bar (should be: 0,8-1,4 bar) the mechanical pressure cut-off was checked: pmax: is: 1,84 bar (should be: 1,8-2,5 bar) pmin: is: 1,57 bar (should be: >1,5 bar) safety clamp was checked: pmin: is: 1,76 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 -0,94%.((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.(see lab results attached to the pc-notification) 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.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 23m24e8st5 ---------------------------------------------------------------- 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.

Event Description

As reported by the user facility information by bbm sales organization in france: non comform product administration time compared to the requested flow rate (administration twice as slow).".

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number 400640747.1.General information: complaint: (b)(4).---------------------------------------------------------------- 2.Information to the sample: 2.1 model: infusomat space 2.2 article number: (b)(4) 2.3 serial number/batch: (b)(6) 2.4 software version: (b)(4) 2.5 hours of operation: (b)(4) 2.6 further information: n/a ---------------------------------------------------------------- 3.Investigation results: 3.1 history inspection: the device history files were read and analyzed.Due to the lack of a precise error description, the history could not be analyzed extensively.The last infusions were investigated.No anomalies could be detected.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 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: 0,50 bar (should be: 0,1-0,7 bar) pressure stage 9: is: 1,13 bar (should be: 0,8-1,4 bar) the mechanical pressure cut-off was checked: pmax: is: 1,84 bar (should be: 1,8-2,5 bar) pmin: is: 1,57 bar (should be: >1,5 bar) safety clamp was checked: pmin: is: 1,76 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 (b)(4).((accuracy of set delivery rate should be:(b)(4) 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.3.7 test equipment: description: typ nr.: lab.-id.-nr.Sika (b)(4) (b)(4) 3.8 for examination used disposables: description: ref.: lot: infusomat space line (b)(4) 23m24e8st5 ---------------------------------------------------------------- 4.Judgment: 4.1 the complaint could not be confirmed.Summing up all tests, the infusomat space operates within our specification.No product deviation.Addition information: n/a.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: 18794022
• MDR Text Key: 337516962
• Report Number: 9610825-2024-00113
• 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 Health Care Professional
• 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: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8713050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2020
• 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