MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE PLUS SYS W/PED.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX819T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: no abnormalities at first viewing.Permeability test: the test showed that the m.Blue plus is non-permeable.To determine the location of the occlusion, the shunt system was separated and each element was tested individually for permeability.When separating the components, the kink protections of the catheters were removed individually to inspect the condition under them.During this process, a twist of the distal catheter could be detected, see picture 10.After separation of the components, all valves could be assessed as permeable.The distal catheter was also permeable after removal of the kink protection.Results: based on our investigation results, we have determined that there was a blockage in the shunt system at the time of our investigation.The cause of the blockage is the detected twist of the distal catheter under the kink protection.All catheters are tested 100% for permeability before sterilization and shipping.The fact that a blockage of this type was not detected can only be attributed to an individual error of the staff.Therefore, we have initiated actions that will prevent a recurrence of a similar case in the future.This will be addressed in a capa (corrective and preventive action) case.Additional actions will be implemented in form of a capa and a report to the responsible authority was required.A credit note will be generated.
Event or Problem Description
It was reported that a m.Blue plus (#fx819t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the shunt system showed no drainage immediately after implantation.The product was removed and a replacement product was used.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 1 year; weight: 10 kilograms (kg); gender: female.

• Brand Name: M.BLUE PLUS SYS W/PED.CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 16950488
• Report Number: 3004721439-2023-00132
• Device Sequence Number: 3614143
• Product Code: JXG
• UDI-Device Identifier: 04041906504823
• UDI-Public: 4041906504823
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FX819T
• Device Catalogue Number: FX819T
• Device Lot Number: 20062002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 YR
• Patient Sex: Female
• Patient Weight: 10 KG