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

Catalog Number 8713050

Device Problem Inaccurate Flow Rate (1249)

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

Event Type  Injury  

Event Description

As reported by the user facility information by bbm sales organization in france: "flowrate deviation" "flow out of tolerance.".

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).The device was investigated in our service repair shop in melsungen, germany.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 sample was subjected to a visual and functional examination.Visual inspection: during the visual inspection of the infusomat space, the production seal on the lower housing as well as all cover caps of the screw pillars were available and undamaged.The device was slightly dirty and it was possible to recognized age related signs of wear and tear.Functional inspection: as part of the functional check the self-test of the infusomat space could be successfully performed.An infusomat space line could be inserted and was recognized by the pump.After the line selection the delivery mode could be started without any reservations.After the functional test a delivery accuracy measurement according to iec 60601-2-24 was arranged.Here a nominal delivery rate of 100 ml/h was chosen.The assessed mean deviation "a" of the second operating hour was measured with a value of -2,25 %.This value is inside the instruction for use predefined performance characteristic of the device (+-5%).The downstream sensor was checked.For this the electrical pressure cut-off and the mechanical pressure limitation were checked.Furthermore the pressure stability of the safety clamp concerning the percolation (free flow possibility) was checked.The device fulfills the required values according to the specifications of the technical safety check (tsc).The device was disassembled.The inside of the device was slightly dirty, but no damages could be found.The complaint could not be confirmed.Summing up all tests, the perfusor 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: 16686205
• MDR Text Key: 312758517
• Report Number: 9610825-2023-00096
• 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
• Report Date: 04/05/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2013
• 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