MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 10 SHUNT SYSTEM; HYDROCEPHALUS MANAGEMENT

Model Number	FX812T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a m.Blue (#fx812t) valve was to be implanted.The complainant described that the valve is blocked during the adjustment before using.During the adjustment process, the housing membrane blocked in the depressed condition and did not return into the original position.Another product was used and the operation was performed successfully.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: -scratches -damages to the housing membrane permeability test: the test showed that the m.Blue is permeable.Computer control test: the computer controlled test showed the opening pressure of the differential unit of the valve, at a reference flow rate of 20 ml/h in a horizontal position of the valve, to be 10.56 cmh2o.This is within the specified tolerance of 10 ± 3 cmh2o.Additionally, the gravitational unit of the valve was tested according to standard procedure in the vertical position of the valve.At an opening pressure of 14 cmh2o in the vertical position, a pressure of 24 +6/ -12 cmh2o is expected.The results indicated that at a reference flow of 20 ml/h in the vertical position, the gravitational unit of the m.Blue had a pressure of 13.29 cmh2o.This is within the specified tolerance of 24 +6/ -12 cmh2o.Adjustability test: the m.Blue was found to be adjustable to all pressure settings.The valve membrane did not return to the original state after the first adjustment and remained depressed.The brake is still active.Braking force and brake function test: the braking force of the gravitational unit of the m.Blue was not within the specified tolerance, the braking force was lower than expected.Despite the depressed housing membrane, the brake function was given.Internal inspection of product: in order to verify whether the investigated valve was compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid or a manufacturing problem occurred, the valve is finally opened with a special tool.After dismantling of the valve, no deviations were detected.Results: based on our inspection results, some defects have been identified at the membrane which might cause the functional impairment.Additional investigations were necessary to may result in more information of the cause of the impairment.Undoubtedly the product was shipped out in 100% compliancy to the manufacture's declaration after final inspection.

• Brand Name: M.BLUE 10 SHUNT SYSTEM
• 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: 17051425
• Report Number: 3004721439-2023-00157
• Device Sequence Number: 3479709
• Product Code: JXG
• UDI-Device Identifier: 04041906504496
• UDI-Public: 4041906504496
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/02/2023

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 Model Number: FX812T
• Device Catalogue Number: FX812T
• Device Lot Number: 20060415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• 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
• Patient Sex: Unknown