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

Model Number	PV2015L20-A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information about the event has been requested.Investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.H3 other text : device not yet recieved.
Event or Problem Description
It was reported, that the blood flowed backwards to the luer connector.If a leaking part has been reported which could lead to death or serious injury this case is evaluated as reportable considering the worst-case scenario of blood loss.No blood loss or harm to the patient occurred.Manufacturer ref.(b)(4).
Additional Manufacturer Narrative
The failure could be visually confirmed.However, no defect on the outside of the catheter lumen (e.G., ruptures in lumen surface) could be detected.It cannot be excluded that the catheter is damaged inside the lumen.As we could not find defects outside the catheter lumen an investigation at the supplier site was initiated for clarifying the root cause of blood running towards the red connector.A supplemental emdr will be sent when the investigation is completed.
Event or Problem Description
Manufacturer ref.(b)(4).
Additional Manufacturer Narrative
It has been reported that the picco catheter was leaking and blood ran towards the red connector.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.Based on the information stated above, no additional actions will be taken.The complaint will be closed.
Event or Problem Description
Manufacturer referance #: (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: 17708971
• Report Number: 3003263092-2023-00008
• Device Sequence Number: 6731350
• Product Code: KRB
• UDI-Device Identifier: 14250094500938
• UDI-Public: (01)14250094500938
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup,Followup
• Report Date (Section B): 06/20/2024

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: PV2015L20-A
• Device Catalogue Number: 6885049
• Device Lot Number: 721357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 11/02/2023; 06/20/2024
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 11/21/2023; 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown