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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL INC. INFUSOMAT SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 490103
Device Problem Fluid 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). ".
 
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Brand NameINFUSOMAT
Type of DeviceSET, 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 Key10891846
MDR Text Key217952471
Report Number2523676-2020-00335
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K142036
Number of Events Reported1
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 Received11/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number490103
Device Catalogue Number490103
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/24/2020 Patient Sequence Number: 1
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