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

Model Number PV8115

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

The patient was diagnosed with respiratory obstruction and admitted to the icu.Cardiac output and hemodynamic parameters were measured using a picco catheter and pv8215.At 2pm on (b)(6) 2024, the doctor followed the normal operation to connect the picco catheter and the pressure monitoring kit to the device.After that the nurse found that the monitored invasive blood pressure waveform was unusual and the data was not displayed.They immediately checked the condition of the pressure line, the connection was correct, but the stopcock on the pressure line was continuous leaking.The nurse checked the connection of the line again and made sure that the connection was well and that the ns was leaking from the stopcock.Then they replaced a new pv8215, no leakage any more and picco function worked well.Manufacturer reference (b)(4).

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 22jk13, catalogue #6882817, manufacturing date: 10/31/2022, expiration date: 09/30/2025, (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

Manufacturer reference #: (b)(4).

Manufacturer Narrative

It has been reported that after the nurse found that the monitored invasive blood pressure waveform was unusual and the data was not displayed.That the 3-way stopcock was leaking from the luer-lock towards the center.The defective pv8215 was replaced and no harm to the patient was reported.The customer has sent a video of the defective product.It is clearly visible that the 3-way stopcock of the pv8215 is leaking at the luer lock.However, it is our understanding that the product in question is not available to be returned to us for analysis.We regret not having the opportunity to examine the actual product.Therefore, the root cause cannot be identified.Nevertheless, we investigated a retained sample from the same lot.A visual inspection by naked eye of the stopcock connections from the retained sample did not show any deviation or cracks at the luer-lock.A performed leakage test by flushing water through the tubing and the stopcock did not show any signs of leakage.Therfore, a manufacturing failure can be excluded, but the root cause for the reported issues can not be determined.(b)(4).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.

• 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: 18853592
• MDR Text Key: 337660622
• Report Number: 3003263092-2024-00003
• 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,Followup
• Report Date: 05/17/2024

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 05/17/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 64 KG