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

Model Number	PV2013L07-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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).
Additional 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 or Problem Description
Manufacturer reference #: (b)(4).

• Brand Name: PICCO CATHETER
• Common Device Name: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• MDR Report Key: 10256776
• Report Number: 3003263092-2020-00007
• Device Sequence Number: 19454262
• Product Code: KRB
• UDI-Device Identifier: 04250094500948
• UDI-Public: (01)04250094500948(17)230331(10)639323
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K171620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/28/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Weight: 9