MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS SE PICCO CATHETER; PROBE, THERMODILUTION

Model Number	PV2015L20-A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It has been reported that there was fluid leakage occurred at the connection between the picco catheter and a arterial pressure transducer.The problem was solved by replacing the picco catheter with a new one.No harm to the patient was reported.The complained product is not available for investigation.Additionally, a pictures was provided by the user.According to the send picture the issue might not be originate from the catheter but from the pressure transducer.However, it is our understanding that the product in question is not available to be returned to us for analysis.We regret not having the opportunity to examine the actual product.Therefore, the root cause cannot be identified.A production error is unlikely, as a 100% leakage test is performed at during manufacturing.There is no indication for a systematic root cause as a deficiency of design, production or material considering the very low complaint rate ((b)(4), considering root cause).Overall, investigations did indicate that the device failed to meet its specification when the event occurred.A relationship between the device and the complaint is therefore, in worst case scenario, considered as likely.Upon the complaint occurrence the device was involved and used on a patient for advanced hemodynamic monitoring.The issue is monitored on a regularly basis in order to detect early trends.As there is no trend for this kind of issue no additional actions will be taken.With the information stated above the complaint will be closed.
Event or Problem Description
Paciente con inestabilidad hemodinamica, por indicación medica se realiza solicitud de cateter picco para monitoria hemodinamica invasiva.En el momento de realizar la conexión a linea arterial femoral derecha, se observa fuga de liquido en el transductor arterial, se realiza verificación del mismo, en 3 oportunidades, se ajustan llaves, sin embargo persiste el incidente, por tal motivo no se logra tomar hemodinamia del paciente y requiere cambio del dispositivo medico el cual funciona correctamente.This is an automated draft translation - if any uncertainty contact the local ssu immediately: patient with hemodynamic instability, due to medical indication, a picco catheter is requested for invasive hemodynamic monitoring.At the time of making the connection to the right femoral arterial line, a fluid leak is observed in the arterial transducer, it is verified on 3 occasions, keys are adjusted, however the incident persists, for this reason it is not possible to take the patient's hemodynamics and a change of the medical device is required, which works correctly.

• Brand Name: PICCO CATHETER
• Common Device Name: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• Manufacturer (Section G): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• Manufacturer Contact: diana kitschke ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 21525687
• Report Number: 3003263092-2025-000000
• Device Sequence Number: 15849208
• Product Code: KRB
• UDI-Device Identifier: 04250094500931
• UDI-Public: (01)04250094500931(17)281031(11)231114(10)800041
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K171620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PV2015L20-A
• Device Catalogue Number: 6885049
• Device Lot Number: 800041
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 60 KG