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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS SE PULSION PULSIOCATH THERMODILUTION CATHETERS; PROBE, THERMODILUTION
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PULSION MEDICAL SYSTEMS SE PULSION PULSIOCATH THERMODILUTION CATHETERS; PROBE, THERMODILUTION Back to Search Results
Catalog Number PV2014L22N
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ischemia (1942); Occlusion (1984)
Event Date 08/26/2018
Event Type  Injury  
Manufacturer Narrative
Information provided by the customer revealed that the patient suffered from a hit ii, a heparin induced thrombocytopenia.Further information surrounding the event has been requested and investigation is ongoing.A supplemental medwatch report will be sent when the investigation is completed.(b)(4).
 
Event Description
It was reported that there was an occlusion of the a.Brachialis and an ischemia in the arm after using the picco catheter for 7 days.Surgical intervention was necessary.During the time of request the patient status was stable, but restricted due to the overall situation.(b)(4).
 
Event Description
(b)(4).
 
Manufacturer Narrative
The involved catheter was not returned and the batch number was not provided despite several requests.An investigation of a retain sample and a dhr review of the same batch could not be performed.A review of potential applicable dhrs was performed, but no deviations relevant to the reported issue could be detected.A similar catheter with greater length was tested in (b)(6) 2016 for its hemocompatibility.The results show that the requirements for the interaction of the test item with blood according to the applicable iso 10993-4 are fulfilled.The issue is monitored on the market.The rate of complaints about a thrombosis in association with a picco catheter known to us is far below the published averages of complications with arterial catheters.On the basis of the overall circumstances and the investigations of similar complaints the incident is seen as a known complication of arterial cannulation.The instructions for use (ifu) have several indications about the risk of thrombosis.This evaluation is supported by information provided by the customer, which revealed that the patient suffered from a hit ii, a heparin induced thrombocytopenia.Please note, getinge usa sales, llc (importer) is submitting the report on behalf of pulsion medical systems se (exemption number e2018007).Contact: (b)(6).
 
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Brand Name
PULSION PULSIOCATH THERMODILUTION CATHETERS
Type of Device
PROBE, THERMODILUTION
Manufacturer (Section D)
PULSION MEDICAL SYSTEMS SE
pulsion medical systems se
hans-riedl-str. 21
85622 feldkirchen
GM 
MDR Report Key7890615
MDR Text Key120768542
Report Number3003263092-2018-00009
Device Sequence Number1
Product Code KRB
Combination Product (y/n)N
PMA/PMN Number
K072364
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 10/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberPV2014L22N
Was Device Available for Evaluation? No
Device AgeYR
Date Manufacturer Received08/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age49 YR
Patient Weight92
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