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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS AG PULSION PULISOCATH THERMODILUTION CATHETERS
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PULSION MEDICAL SYSTEMS AG PULSION PULISOCATH THERMODILUTION CATHETERS Back to Search Results
Catalog Number PV2014L16-A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular System (Circulation), Impaired (2572)
Event Date 07/22/2015
Event Type  malfunction  
Manufacturer Narrative
Further information surrounding the event has been sought.A supplemental medwatch report will be provided when the investigation is finished.
 
Event Description
Patient had a brachial picco catheter placed.It was noted that the patient had quite reduced blood flow to the hand., which felt cold and looked pale.In view of this the catheter was removed.No information was received regarding long-term effects.(b)(4).
 
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Brand Name
PULSION PULISOCATH THERMODILUTION CATHETERS
Manufacturer (Section D)
PULSION MEDICAL SYSTEMS AG
feldkirchen
GM 
Manufacturer Contact
volker humbert
hans-riedl-str. 17
feldkirchen 85622
GM   85622
9459914503
MDR Report Key5048887
MDR Text Key25114647
Report Number3003263092-2015-00030
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 07/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPV2014L16-A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/22/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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