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

Model Number PV8115

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

No product has been returned, therefore a retain sample of the same batch was investigated.No deviation or abnormalities were detected during visual inspection.A leakage test and a zeroing functional test were carried out and passed.No deviation could be detected.A review of the dhr could not identify any non conformities or deviations relevant to the reported issue.No further complaints have been received for this batch.No similar complaints were received within the last 12 months for this batch either.Investigation has been performed as far as possible.It can be concluded that a systematic weakness of production or design is regarded as unlikely due to the absence of a trend.It is not known if a handling error during use occurred.A production error is regarded as unlikely, as the problem was found after using the product for a period of time.This evaluation does not indicate that the device failed to meet its specification.The concerned product has not been returned for further investigation.Upon the event occurrence the device was involved and used on a patient for advanced hemodynamic monitoring.No trend has been identified, the trend rate is below <0,01 %.The issue will be further monitored on the market in order to identify trends.

Event Description

It was reported that the thermodilution catheter and pressure monitoring kit was used, to perform picco hemodynamic monitoring on (b)(6) 2020.After using for a period of time, the nurse found that the blood pressure and blood temperature could not be monitored, and the pressure monitoring leaked at the luer connection which is in contact with arterial blood pressure.No harm or clinical consequences occurred.No blood loss defined.Manufacturer reference #: (b)(4).

• 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: sevde karacabey ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 11163884
• MDR Text Key: 228883351
• Report Number: 3003263092-2021-00001
• 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: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/13/2021

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: 6886184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/27/2020
• Initial Date FDA Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 40