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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CARESITE SET, ADMINISTRATION, INTRA

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B. BRAUN MEDICAL INC. CARESITE SET, ADMINISTRATION, INTRA Back to Search Results
Model Number 470108
Device Problem Fluid Leak (1250)
Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b. Braun medical internal report number (b)(4). The device involved has not been received for evaluation and the investigation is ongoing at this time. A follow up will be submitted when the investigation results become available.
 
Event Description
As reported by the user facility: during the first 15 minutes of the blood transfusion, no abnormalities were noted. However, 30 minutes later, the product leaked. Blood was observed at the anti-reflux valve. The transfusion was stopped, the device was changed, and the transfusion was resumed without issues.
 
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Brand NameCARESITE
Type of DeviceSET, 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
DR
Manufacturer Contact
jonathan severino
901 marcon blvd.
allentown, PA 18109
4847197287
MDR Report Key9699370
MDR Text Key180418656
Report Number2523676-2020-00036
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K942988
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,Followup
Report Date 03/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470108
Device Catalogue Number470108
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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