MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 5 SYS W/PED.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX826T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a m.Blue 5 system (#fx826t) was implanted during a procedure performed on (b)(6) 2024.According to the complainant, the shunt system caused an overdrainage.The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 14 weeks height: 55 cm weight: 4.3 kg gender: femal.
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, visible deposits in the reservoir were determined.No significant deformation or damage of the valve was detected.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to investigate the claim of over- drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in both positions, the horizontal as well as the vertical position.The results show that the m.Blue operates within the accepted tolerance in both positions.Adjustment test: the m.Blue valve was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Internal inspection: after dismantling of the valve, deposits were found in m.Blue.Results: based on our investigation results, we can determine deposits.The deposits had no effect to the technical properties at the time of the investigation.The cause of the aforementioned functional impairment is not known to us at the time of the examination.Organic matter in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.

• Brand Name: M.BLUE 5 SYS W/PED.SPRUNG 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: 19670469
• Report Number: 3004721439-2024-00185
• Device Sequence Number: 17871993
• Product Code: JXG
• UDI-Device Identifier: 04041906504601
• UDI-Public: 4041906504601
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/03/2024

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: FX826T
• Device Catalogue Number: FX826T
• Device Lot Number: 20074096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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: 3 MO
• Patient Sex: Female
• Patient Weight: 4 KG