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

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.

• Brand Name: CARESITE® (LAD) SYSTEM
• Type of Device: CARESITE 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 Key: 5823694
• MDR Text Key: 50506965
• Report Number: 9614279-2016-00061
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K083723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 470108
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 07/26/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 86 YR