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

Model Number PV8115

Device Problem Leak/Splash (1354)

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

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

According to provided information the device is not available as it was discarded.The following similar device is under complaint: (b)(4), lot 22bf01, catalogue #6882817, manufacturing date: 02/28/2022, expiration date: 01/31/2025, (b)(4).A supplemental emdr will be sent when the investigation is completed.H3 other text : device requested but discarded by user due to country specific regulations.

Event Description

It has been reported that after opening and priming the pressure transducer system, it was found to be leaking sodium chloride (nacl) solution.The faulty picco monitoring kit was replaced with a new picco monitoring kit and everything was fine.No patient harm has been reported.

• Brand Name: PICCO MONITORING KIT
• 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: 18902321
• MDR Text Key: 337660096
• Report Number: 3003263092-2024-00007
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K991886
• 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
• Report Date: 03/14/2024

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
• Device Operator: Health Professional
• Device Model Number: PV8115
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Female