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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PFM MEDICAL CPP SA XCELA POWER INJECTBALE PORT

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PFM MEDICAL CPP SA XCELA POWER INJECTBALE PORT Back to Search Results
Model Number H965451090
Device Problem Difficult to Flush (1251)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2019
Event Type  malfunction  
Manufacturer Narrative
Date event was determined to be reportable based on additional information received was 02/18/2020. Failure classification: leak or obstruction. Inventory review: none left in stock. Dhr review: no non-conformances observed that could contribute to this issue. All in process testing passed for leaks. No testing is performed for obstructions. Investigation of returned product: after further investigation of the returned product, it appears that a blood clot formed at the entrance of the pin connector. Indeed rinsing was not possible with an obstruction in the component. Risk management review: the risk is identified in the product risk analysis and frequency is acceptable. Unable to determine root cause of the blood clot inside the port body. Likely the blood clot was aspirated out of the patient during insertion and the remaining blood in the port body coagulated around it.
 
Event Description
Port was not flushing properly when preparing it for a patient. The issue occurred when the device was implanted in the patient. We flush all catheters and ports prior to insertion with injectable saline. Port was placed and when the surgeon checked to see how well it flushed it would not flush. When they disconnected the port from the catheter it did flush. After placing back in the patient and checking again and a few more times each time the port was connected to the catheter to check for placement it would not flush. New port was then obtained and placed.
 
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Brand NameXCELA
Type of DevicePOWER INJECTBALE PORT
Manufacturer (Section D)
PFM MEDICAL CPP SA
9, allée du quartz
2300 la chaux-de-fonds,
SZ
Manufacturer (Section G)
PFM MEDICAL CPP SA
9, allée du quartz
2300 la chaux-de-fonds,
SZ
Manufacturer Contact
troy taylor
1916 palomar oaks way
suite 150
carlsbad, ca 
7588749
MDR Report Key9721483
MDR Text Key205350089
Report Number2032582-2020-00002
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073210
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH965451090
Device Catalogue NumberH965451090
Device Lot Number142624000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/25/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/18/2020 Patient Sequence Number: 1
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