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

Model Number 490103

Device Problem Fluid/Blood Leak (1250)

Patient Problems High Blood Pressure/ Hypertension (1908); Tachycardia (2095); Increased Respiratory Rate (2486)

Event Date 10/12/2020

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).As reported by the user facility, it has been confirmed that the batch number is unknown and no samples are available for further evaluation.Without the actual device and/or lot number, a thorough investigation could not be performed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If additional pertinent information becomes available, a follow-up will be submitted.

Event Description

"as reported by the user facility: blood from the ij central line backflowed in the iv tubing in the distal port, preventing the patient from receiving medication (fentanyl, propofol, and esmolol).The patient experienced high blood pressure of >265/132 per art-line reading.The distal port was defective, and the ventilator alarmed for high volume pressure.The patient became tachypnic and hypertensive (>240 and hr >140).The patient lost an unknown volume of blood.Other relevant history as reported by the user facility: patient known for decrease hg 86).Had hypertensive event (known cva + bleed).".

• Brand Name: INFUSOMAT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown 18109
• Manufacturer (Section G): B. BRAUN DOMINICAN REPUBLIC, INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon boulevard; allentown, PA 18109 ; 4847197287
• MDR Report Key: 10891846
• MDR Text Key: 217952471
• Report Number: 2523676-2020-00335
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964302107
• UDI-Public: 04046964302107
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K142036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 490103
• Device Catalogue Number: 490103
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention