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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN DOMINICIAN REPULIC INC. ULTRASITE® SET, ADMINISTRATION, INTRA

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B. BRAUN DOMINICIAN REPULIC INC. ULTRASITE® SET, ADMINISTRATION, INTRA Back to Search Results
Catalog Number 415113
Device Problems Fluid Leak (1250); No Apparent Adverse Event (3189)
Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Increased Respiratory Rate (2486)
Event Type  malfunction  
Manufacturer Narrative
(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: it was reported that, "on the evening of (b)(6) 2019, a patient in (b)(6) hospital leaked medicines when he was infused with special medicines (the department said it was due to the leakage of positive pressure joint). The patient's physical signs were stable after rescue. It is impossible to judge whether it is a product quality problem by head nurse's description. Visiting on (b)(6), we learned that another case of joint cracking occurred in this patient on (b)(6), and the sample has been retained. The patient died of ineffective rescue. ".
 
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Brand NameULTRASITE®
Type of DeviceSET, ADMINISTRATION, INTRA
Manufacturer (Section D)
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 Key9205134
MDR Text Key162794809
Report Number9614279-2019-00198
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K031923
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 11/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number415113
Device Lot Number0061629919
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/04/2018
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: 10/17/2019 Patient Sequence Number: 1
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