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

Model Number PV8115

Device Problem Leak/Splash (1354)

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

Event Date 03/04/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024, the patient was in unstable hemodynamic , the eicu doctor decided to perform picco monitoring.After checking the packaging integrity and expiration date of the pv8215 and the picco catheter, they were performed priming the pv8215 and connected to the femoral arterial picco catheter.They found there was blood returning to the pressure line.The nurse checked the connectors of the whole pressure monitoring system, everything was normal and not loose.The pressure of the pressurized belt was 300mmhg, but the blood still flowed back to the line.Then the nurse carefully checked the whole pressure monitoring and found that the bottom of the transducer was leaking ns (saline).They immediately replaced the defective one with a new pv8215, the pressure system worked well.Manufacturer reference #: (b)(4).

Manufacturer Narrative

The following similar device is under complaint: pv8215, lot 22jf04, catalogue #6882817, manufacturing date: 10/31/2022, expiration date: 09/30/2025, udi: (b)(4).A supplemental emdr will be sent when the investigation is completed.H3 other text : device requested but pending answer.

• Brand Name: PCCO 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: 19057215
• MDR Text Key: 339577157
• Report Number: 3003263092-2024-00009
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PV8115
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female