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

Model Number PV2015L20-A

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2023

Event Type  malfunction  

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 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).

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 Description

Manufacturer ref.(b)(4).

• Brand Name: PICCO CATHETER
• Type of Device: 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
• MDR Text Key: 322938309
• Report Number: 3003263092-2023-00008
• Device Sequence Number: 1
• Product Code: KRB
• UDI-Device Identifier: 14250094500938
• UDI-Public: (01)14250094500938
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K171620
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/02/2023
• Date Device Manufactured: 12/06/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.