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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS SE PULSION PULSIOCATH THERMODILUTION CATHETERS; KRB
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PULSION MEDICAL SYSTEMS SE PULSION PULSIOCATH THERMODILUTION CATHETERS; KRB Back to Search Results
Catalog Number PV2014L08-N
Device Problem Disconnection (1171)
Patient Problem No Information (3190)
Event Date 10/14/2013
Event Type  malfunction  
Manufacturer Narrative
The reported picco catheter was returned for investigation.The reported problem could be confirmed by ocular inspection.The root cause for the disconnection is seen in a production error.Please note, this event is being filed as a retrospective mdr as a result of a review of our complaint database.
 
Event Description
It was reported that during use of a picco catheter on a patient the luer lock detached from the extension line.(b)(4).
 
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Brand Name
PULSION PULSIOCATH THERMODILUTION CATHETERS
Type of Device
KRB
Manufacturer (Section D)
PULSION MEDICAL SYSTEMS SE
feldkirchen
GM 
Manufacturer Contact
volker humbert
hans-riedl-str. 17
feldkirchen 85622
GM   85622
9459914503
MDR Report Key4995030
MDR Text Key22752966
Report Number3003263092-2015-00027
Device Sequence Number1
Product Code KRB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K072364
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Report Date 10/14/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPV2014L08-N
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2013
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/14/2013
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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