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

Model Number PV2013L07-A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2020

Event Type  malfunction  

Manufacturer Narrative

Further information has been requested and investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.Device has not been returned by the hospital as it was discarded.

Event Description

It has been reported that blood has been observed on picco catheter connector.On disconnecting the lumen, blood was noted inside the red connector as well as on the thermistor wire attached to it.There was no blood outside the arterial lumen or on the outside of the thermistor lumen.Blood temperature has not been monitored on the screen.No harm or clinical consequences occurred.Manufacturer reference #: (b)(4).

Manufacturer Narrative

The concerned product has not been returned as it was discarded by the hospital.Therefore it is not possible to determine if the used product had any malfunction or any deviation from the specification, that contributed to the event.A retain sample of the same batch has been investigated but no deviation to specification could be detected during visual and functional testing of the described failure.A dhr check could not identify any deviations or abnormalities relevant to the reported issue.An investigation has been performed on the basis of the provided pictures: the hospital had removed the red cup of the thermistor connector and traces of blood could be detected in the thermistor plug.A systemic root cause as a deficiency of design, production or material is considered as unlikely due to the very low complaint rate (< 0,01 %, considering all types of picco catheters).No similar complaints have been received since 2017.Considering the provided information and product experience, the most probable root cause is seen in a single production process problem during molding of the channel separation.This evaluation indicates that the device failed to meet its specification, however the involved product has not been returned.Upon the event occurrence the device was involved and used on a patient for advanced hemodynamic monitoring.100 % leak tests are performed during production.The issue will be further monitored on the market in order to identify early trends.

Event Description

Manufacturer reference #: (b)(4).

• Brand Name: PICCO CATHETER
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• MDR Report Key: 10256776
• MDR Text Key: 201542888
• Report Number: 3003263092-2020-00007
• Device Sequence Number: 1
• Product Code: KRB
• UDI-Device Identifier: 04250094500948
• UDI-Public: (01)04250094500948(17)230331(10)639323
• Combination Product (y/n): N
• PMA/PMN Number: K171620
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

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 Expiration Date: 03/31/2023
• Device Model Number: PV2013L07-A
• Device Catalogue Number: 6886144
• Device Lot Number: 639323
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 07/22/2020
• Supplement Dates FDA Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Weight: 9