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 Date 01/12/2024

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 finland: the patient goes to the intensive care unit with intravenous hydration through a pump dripping.Before the day of fluid therapy, it was noticed that there is still about half the liquid in the plasmalyte 1000 ml bag, although the pump reports that the amount of liquid is only about 14 ml.It has also been recorded in the information system that 986 ml of fluid has gone.

• 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: 18818242
• MDR Text Key: 336681352
• Report Number: 9610825-2024-00136
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• 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