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 Discomfort (2330)

Event Date 10/16/2022

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).The complaint is under evaluation.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" customer statement: "problem with continuous flow treatment.Free flowing (36 ml in 30 minutes) consequence: patient's discomfort".

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report 400574008.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: 102267 2.4 software version: h030002 2.5 hours of operation: 24217 h 2.6 further information: n/a 3.Investigation results: 3.1 history inspection: the device history files were read out and analyzed.The history files at 2022-10-16 (specified date of the incident) were investigated.At 2022-10-16 no volume was infused by the pump.Furthermore, no anomalies inside the history files 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.The device shows liquid residues at the outside.The safety clamp shows sharp edges that could damage the line.Furthermore, the device shows no anomalies.3.3 functional inspection: a functional test was performed.The device passes the self-test.A space line was inserted, 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: for 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 mean deviation "a" of the second operating hour was measured and resulted in a value of -2,96%.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 faults could be detected, to investigate the inside the device was disassembled complete.The contacts of the ribbon cable that connects the mainboard with the operating unit shows oxidized contacts.Furthermore, the mainboard shows liquid residues and oxidized contacts.In addition, the device shows no more anomalies.4.Judgment: 4.1 the complaint could not be confirmed.Summing up all tests, the infusomat space operates within our specification.No flowrate deviation could be detected.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: 15877051
• MDR Text Key: 307677407
• Report Number: 9610825-2022-00500
• 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: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• 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
• Date Manufacturer Received: 10/21/2022
• 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: Reuse
• Patient Sequence Number: 1