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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS SE PULSIOCATH PICCO MONITORING KIT
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PULSION MEDICAL SYSTEMS SE PULSIOCATH PICCO MONITORING KIT Back to Search Results
Catalog Number PV8215US
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/02/2014
Event Type  malfunction  
Manufacturer Narrative
The reported product was not returned for investigation.Therefore it is not possible to confirm if there was a malfunction or any deviation from the specification.Our supplier investigated a product of the same batch and did not find any deviations from the specification.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 luer lock connections of a picco monitoring kit were loose during use on a patient.No known impact or consequences to patient.(b)(4).
 
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Brand Name
PULSIOCATH PICCO MONITORING KIT
Manufacturer (Section D)
PULSION MEDICAL SYSTEMS SE
feldkirchen
GM 
Manufacturer Contact
volker humbert
hans-riedl-str. 17
feldkirchen 85622
GM   85622
945991503
MDR Report Key4995014
MDR Text Key22748554
Report Number3003263092-2015-00012
Device Sequence Number1
Product Code KRB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K020587
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 06/02/2014
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 NumberPV8215US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2013
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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