MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG M.BLUE 0 SYS W/PED.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX815T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that an m.Blue (part # fx815t) was implanted during a procedure performed on an unknown date.According to the complainant, the device was believed to be blocked.The complaint device has been returned to the manufacturer for evaluation.Although requested, no additional information has been made available.
Additional Manufacturer Narrative
Manufacturing and quality control data: the m.Blue® was manufactured by a qualified employee on november 2021.Deviations during assembly did not occur.The product was finally tested as article fx815t and released for packaging and sterilization and was sterilized by miethke.The m.Blue® has a normal pressure range of 0 to 40 centimeters water (cmh2o).A fixed opening pressure of zero (0) cmh2o in the horizontal position (differential pressure unit) and an additional adjustable gravitational unit of 0 to 40 cmh2o in the vertical position.Both realized in one valve.The parameters after completion of the valve assembly were tested at a flow rate of 5 milliliters per hour (ml/h) or 50 ml/h at the gravitational unit set pressures and 0, 10, 20, 30 and 40 cmh2o at the differential pressure and were found to meet specifications.All tested parameters were assessed according to specifications.Visual inspection: no abnormalities were detected during the visual examination.Permeability test: a permeability test was performed which showed that the valve was not permeable.Adjustability test: the m.Blue® was found to be non-adjustable within the specified range.Braking force and brake function test: the braking force test indicates that the brake function of the m.Blue® was present.However, due to the non-adjustability of the valve, an investigation of the braking force was not possible.Internal inspection of product: further evaluation was performed by dismantling the valve; deposits were found in the m.Blue®.Results: based on the investigation results, the valve was confirmed to have a blockage and was not adjustable.The deposits observed inside the valve were the likely cause of the blockage and the non-adjustability.Existing deposits in the cerebrospinal fluid (csf) can temporarily impair the valve functionality and is a described concomitant symptom in hydrocephalus therapy.Additionally, a defect at the time of release was excluded; the valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.
Event or Problem Description
Patient details: age - 3 years, weight - 12.65 kilograms (kg), height - 98.5 centimeters (cm), gender - female.

• Brand Name: M.BLUE 0 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: 14288095
• Report Number: 3004721439-2022-00117
• Device Sequence Number: 11152765
• Product Code: JXG
• UDI-Device Identifier: 04041906504519
• UDI-Public: 4041906504519
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2022

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: FX815T
• Device Catalogue Number: FX815T
• Device Lot Number: 20056163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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: 3 YR
• Patient Sex: Female
• Patient Weight: 13 KG