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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS SE PULSION PULSIOCATH THERMODILUTION CATHETERS
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PULSION MEDICAL SYSTEMS SE PULSION PULSIOCATH THERMODILUTION CATHETERS Back to Search Results
Catalog Number PV2015L20-N
Device Problems Fracture (1260); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/02/2014
Event Type  malfunction  
Manufacturer Narrative
The reported catheter was returned for investigation.The reported problem could be confirmed.The appearance of the present cracks as well as the breaking behavior during stress tests pointed to the root cause use of application of organic disinfectants.As this is not indicated according to the product's ifu this is seen as an off-label use.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 after a successful placement of a picco catheter on a patient, the physician found leakage on the extension line.Visual inspection showed a crack on the plastic part of the connector.There was no known impact or consequence to patient.(b)(4).
 
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Brand Name
PULSION PULSIOCATH THERMODILUTION CATHETERS
Manufacturer (Section D)
PULSION MEDICAL SYSTEMS SE
fieldkirchen
GM 
Manufacturer Contact
volker humbert
hans-riedl-str. 17
feldkirchen 85622
GM   85622
9459914503
MDR Report Key4995023
MDR Text Key22765813
Report Number3003263092-2015-00018
Device Sequence Number1
Product Code KRB
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Physician
Report Date 09/02/2014
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 NumberPV2015L20-N
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/16/2013
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/02/2014
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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