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

Catalog Number 8713050

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Discomfort (2330)

Event Date 05/23/2022

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.

Event Description

As reported by the user facility information by bbm sales organization in australia: "overinfusion" reason of complaint: the second incident was reported on (b)(6) 2022 (sn # (b)(4), with the report stating that the pump infused medication too quickly and reported an error 44 being displayed on the pump screen.A minor level of patient harm occurred from the incident, with increased patient monitoring required following the incident.The pump was isolated and sent to bts for investigation.When a new infusion was programmed on the pump during bts testing, the following notice was displayed on the pump screen, despite no piggyback infusion being programmed on the pump.

Manufacturer Narrative

The device has been investigated in our service department at b.Braun melsungen ag, 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: n030004.2.5 hours of operation: 1969.2.6 further information: n/a.3.Investigation results: 3.1 history inspection: the device history files were read out and analyzed.No infusion on the day of occurrence on (b)(6) 2022.The last infusion on (b)(6) 2022 was investigated.A space line was inserted, and the infusion started with a rate of 83,3 ml/h.A few seconds later an upstream alarm occurred, the alarm was confirmed and the infusion was continued.Nine minutes later the infusion was stopped and a new therapy with "piggyback" was selected.The infusion started with a rate of 50 ml/h and in the first minutes the upstream alarm occurred, four times.The infusion with piggyback infusion was continued without abnormalities.3.2 visual inspection: a visual inspection was performed.The cover caps on the screw pillars, and the technician seal (61-01-40) on the lower housing were intact and undamaged.The device shows is in a clean state and no visible damaged are to locate.3.3 functional inspection: a functional test was performed.The device passed 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 electronic pressure cut-off was checked: pressure stage 2: is: 0,47 bar (should be: 0,1-0,7 bar).Pressure stage 9: is: 1,19 bar (should be: 0,8-1,4 bar).The mechanical pressure cut-off was checked: pmax: is: 1,89 bar (should be: 1,8-2,5 bar).Pmin: is: 1,64 bar (should be: >1,5 bar).Safety clamp was checked: pmin: is: 1,81 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 mean deviation "a" of the second operating hour was measured and resulted in a value of -1,43%.((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.Liquid residues were found on the lower housing, the emc protection shield and the bottom inner frame.4.Judgment: 4.1 the complaint could not be confirmed.Summing up all tests, the infusomat space operates within our specification.No product deviation.

• Brand Name: INFUSOMAT SPACE
• Type of Device: PUMP, INFUSION, PRODUCT CODE: FRN
• 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 serverino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 14959650
• MDR Text Key: 297972517
• Report Number: 9610825-2022-00261
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• 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?: Yes
• Date Manufacturer Received: 06/21/2022
• 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