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

Model Number	PV2014L16-A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It has been reported that the picco catheter was leaking and blood ran towards the red connector.The catheter has not been returned therfore an investigation was not possible.Furthermore, a provided picture showed blood inside the tubing at the red connecter site.A similar complaint (b)(4) was raised, describing the same problem.Here a investigation was performed in-house and at the supplier site with the following outcome: the product was available for investigation in house.The described problem could be reproduced.For in-depth analysis the defective catheter was send to the supplier for further investigation.The most likely cause is a defect in the inner wall (bubbles) between the lumens in combination with the thermistor wire position against the wall.The wall defect was probably sealed by the wire position.A 100 % leakage test is performed during production an a dhr check did not identify any deviations from specification or non-conformities relevant to the reported issue.The leak could have occurred when the position of the wire was moved during medical procedure.Nevertheless further evaluation of the identified cause will be performed in collaboration with the supplier.There is no indication for a systematic root cause as a deficiency of design, production or material considering the very low complaint rate (< 0,01 %, 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 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.H3: other text : device requested but discarded by user due to country specific regulations.
Event or Problem Description
Our qa colleague found on china national medical device adverse event monitoring information system that the clinician noticed blood flowed backward the red connector of the catheter pv2014l16-a.There was no impact on patient safety, but there was an impact on measurement accuracy.Manufacturer reference (b)(4).

• 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: 19728125
• Report Number: 3003263092-2024-00015
• Device Sequence Number: 12794746
• Product Code: KRB
• UDI-Device Identifier: 04250094500962
• UDI-Public: (01)04250094500962
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2024

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: PV2014L16-A
• Device Catalogue Number: 6885046
• Device Lot Number: 719036
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male