MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INFUSOMAT®; SET ADMINISTRATION INTRA,

Model Number 490105

Device Problems Leak/Splash (1354); Use of Device Problem (1670); Obstruction of Flow (2423); Material Deformation (2976)

Patient Problem Tachycardia (2095)

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: an asa 5e that needed blood and on the first unit stated to leak, not under pressure but on the pump running at 300ml/hr.Prevented me from transfusing a critically anemic pt, then same pt with mod as, now tachycardic on norepi at 20-30, and attempted to start vasopressin but could bc the pump kept saying occlusion, tried all 4 ports of the quad lumen, all caused downstream occlusion, even when open to air it read occlusion, attempted to change pump, with same error.Ultimately had to change the tubing.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and/or lot number.The actual defective device is valuable tool in investigating the cause of this incident.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: INFUSOMAT®
• Type of Device: SET ADMINISTRATION INTRA,
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las america; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17080384
• MDR Text Key: 316703804
• Report Number: 2523676-2023-00284
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964186165
• UDI-Public: (01)04046964186165
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 490105
• Device Catalogue Number: 490105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other