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

Catalog Number 363419

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/29/2023

Event Type  malfunction  

Event Description

As reported by the user facility: detailed inquiry description: blood transfusion started utilizing the pilot tubing asv.15 minutes, no issues noted, then one hour during transfusion rate of blood infusion was increased.It was noted that the blood started to leak from the asv point causing a blood loss of approximately 200ml.Provider was immediately notified of the issue, h and h was ordered and will evaluate if need for further blood to be transfused.No need to follow up with regional team involved.No injury reported.

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 DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17770470
• MDR Text Key: 324059918
• Report Number: 2523676-2023-00555
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964294570
• UDI-Public: (01)04046964294570
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2023

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 Operator: Health Professional
• Device Catalogue Number: 363419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/18/2023
• 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: Initial
• Patient Sequence Number: 1