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 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

A retain sample of the same batch has been investigated.No non-conformities or deviations were detected.A supplemental emdr will be sent when the investigation is completed.Device not available for return.Device was discarded by the hospital.

Event Description

It was reported that the hospital used a picco catheter to monitor the hemodynamics of the patient.After unpacking the product, it was found that the flush device of the pcco monitoring kit was leaking.No harm or clinical consequences occurred.Manufacturer reference #: (b)(4).

Event Description

Manufacturer reference #: (b)(4).

Manufacturer Narrative

No product has been returned, but a video was provided which shows the reported problem.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.Investigation has been performed as far as possible, but the real root cause could not be determined.It can be concluded that a systematic weakness of production or design is regarded as unlikely due to the absence of a trend.As the customer reported that the issue has been detected during unpacking it cannot be excluded that a single error during production led to this issue.It is not known if a handling error during use occurred.This evaluation indicates that the device failed to meet its specification.However, 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.H3 other text : device was discarded by the hospital.

• 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
• MDR Report Key: 10654272
• MDR Text Key: 210649723
• Report Number: 3003263092-2020-00014
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• PMA/PMN Number: K991886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

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: 6882774
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR