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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INFUSOMAT SPACE; INFUSION PUMP
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B. BRAUN MELSUNGEN AG INFUSOMAT SPACE; INFUSION PUMP Back to Search Results
Catalog Number 8713050
Device Problems Device Alarm System (1012); Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/11/2014
Event Type  malfunction  
Event Description
As reported by the user facility (translation of user facility information by (b)(4)): blocked infusion: the pump was set to infuse liquid for 24 hours but it has not infused (only 2 hours), without give the alarm.
 
Manufacturer Narrative
(b)(4).The device is currently shipping from the user facility to (b)(4) for investigation.A follow up report will be provided when the examination results become available.(b)(4).
 
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Brand Name
INFUSOMAT SPACE
Type of Device
INFUSION PUMP
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl-braun str.1
melsungen 34212
GM  34212
Manufacturer Contact
ludwig schuetz, safety officer
carl-braun str.1
melsungen D-342-12
GM   D-34212
661712769
MDR Report Key4341114
MDR Text Key5200686
Report Number9610825-2014-00447
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K062700
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 12/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8713050
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/05/2014
Distributor Facility Aware Date11/27/2014
Device Age7 YR
Event Location Hospital
Date Report to Manufacturer12/05/2014
Initial Date Manufacturer Received 11/27/2014
Initial Date FDA Received12/05/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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