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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. CARESITE® (LAD) SYSTEM CARESITE EXTENSION SET

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B. BRAUN DOMINICAN REPUBLIC INC. CARESITE® (LAD) SYSTEM CARESITE EXTENSION SET Back to Search Results
Catalog Number 470108
Device Problem Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Death (1802); Fever (1858); Inflammation (1932); Sepsis (2067)
Event Date 07/13/2016
Event Type  Death  
Manufacturer Narrative
(b)(4). There were no samples received for evaluation in connection with the reported incident. Multiple attempts made to contact the facility to obtain additional information regarding this event were unsuccessful. A historical review of the customer complaint database, dating back three years, revealed no other reports of this nature against the reported catalog number or product family. Without the lot number, a batch record or sterilization record review could not be performed. There is no current information available to suggest that the b. Braun product caused or contributed to the reported event. If additional pertinent information that impacts the result of the investigation becomes available, a follow-up report will be filed.
 
Event Description
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): the patient admitted to the emergency department on (b)(6) 2016. The catheter with the extension tube put in place. The patient was hospitalized in cardiology care. At the time of discharge of the patient on (b)(6) 2016, the nurse observed a venous inflammation and fever. The hospitalization was extended. On (b)(6) 2016 occurrence of a sepsis, (b)(6) bacteremia followed by death of the patient on (b)(6) 2016. Additional patient information: age: (b)(6). Reason of hospitalization ¿ identified disease: cardiac decompensation with anemia medical history: ischemic heart disease, valvular replacement, acute cardiogenic pulmonary edema with anemia in 2014, chronic iron deficiency anemia. At the moment of the observation of the venous inflammation: type of sepsis and nature of the germ (treatment given): (b)(6) sepsis, setting up of a antibiotherapy (vancomycine+gentamicine) followed by céfazoline+gentamicine.
 
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Brand NameCARESITE® (LAD) SYSTEM
Type of DeviceCARESITE EXTENSION SET
Manufacturer (Section D)
B. BRAUN DOMINICAN REPUBLIC INC.
las americas industrial park
km22 autopista las americas
santo domingo, dominican republic
DR
Manufacturer Contact
eric roden
las americas industrial park
km22 autopista las americas
santo domingo, dominican republic 
DR  
5491000
MDR Report Key5823694
MDR Text Key50506965
Report Number9614279-2016-00061
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K083723
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number470108
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2016
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 Treatment Data
Date Received: 07/26/2016 Patient Sequence Number: 1
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