MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE PLUS WITH PED. CONTROLRESERVOIR; HYDROCEPHALUS MANAGEMNET

Model Number	FX819T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: scratches on the m.Blue, but no deformation of the outer housing or other visible defects could be determined.No abnormalities of the progav 2.0 could be identified.During the visual inspection could be detected that the reservoir is connected in the incorrect flow direction to the valves.Permeability test: a permeability test has shown that the shunt system is blocked.Result: based on our investigation results, we can determine a blockage of the shunt system.Due to the fact that the reservoir was connected in the wrong flow direction, the system is blocked.A credit note will be generated.Additional actions will be implemented in the form of a capa.
Event or Problem Description
It was reported that a m.Blue plus (#fx819t) will be implanted during a procedure performed on (b)(6) 2024.According to the complainant, the system caused an overdrainage/underdraiange and could not be implanted.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the procedure.Age: 10 years weight: 19.4 kg gender: male.

• Brand Name: M.BLUE PLUS WITH PED. CONTROLRESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMNET
• 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: 19044567
• Report Number: 3004721439-2024-00080
• Device Sequence Number: 15594760
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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: 20055890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2021
• 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: 10 YR
• Patient Sex: Male
• Patient Weight: 19 KG