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

Model Number	FX834T
Medical Device Problem Codes	Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
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 a m.Plus plus with sprung reservoir (part # fx834t) was implanted during a procedure performed on an unknown date.According to the complainant, post surgery, the patient has developed pockets of air/gas in the ventricles.The surgeon suspected the sprung reservoir might be the cause of the problem.The m.Blue plus with sprung reservoir is still implanted.No patient data available.
Additional Manufacturer Narrative
Information about the complaint: "post surgery the patient has developed pockets of air / gas in the ventricles" manufacturing and quality control data: due to the limited information and the missing product investigation is restricted to trackability of manufacturing, quality control data, the x-ray pictures and the video.The m.Blue plus was manufactured by a qualified employee on (b)(6) 2021.Deviations during assembly did not occur.The product was finally tested as article fx834t and released for packaging and sterilization and was sterilized by miethke.The m.Blue plus is a combined product of a m.Blue valve (gravitational unit) and a progav 2.0 valve (differential pressure unit).The m.Blue has a normal pressure range of 0 to 40 cmh2o.A fixed opening pressure of 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 ml/h or 50 ml/h at the gravitational unit set pressures and 0, 10, 20, 30 and 40 cmh2o at the differential pressure unit of 0 cmh2o, and were found to meet specifications.The progav 2.0 has a normal pressure range of 0 to 20 cmh2o.The parameters after completion of the valve assembly were tested at a flow rate of 5 ml/h or 50 ml/h at set pressures of 0, 5, 10 and 20 cmh2o, and were found to meet specifications.The m.Blue was pre-adjusted to 20 cmh2o and the progav 2.0 was pre-adjusted to 5 cmh2o in accordance with the specifications.All documented test parameters were assessed according to specifications.An investigation was not possible because the product is still implanted.Statement conclusion information: unfortunately, due to the submitted pictures and the video, we are unable to provide a meaningful analysis.In the pictures could not determine a product failure.A meaningful analysis required an examination of the product.We are not able to explain at this time how this problem occurred.Further actions: from our point of view, no further regulatory actions are required.

• Brand Name: M.BLUE PLUS SYS W/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: 15245660
• Report Number: 3004721439-2022-00260
• Device Sequence Number: 20285862
• Product Code: JXG
• UDI-Device Identifier: 04041906504854
• UDI-Public: 4041906504854
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/18/2022

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 Expiration Date: 03/25/2026
• Device Model Number: FX834T
• Device Catalogue Number: FX834T
• Device Lot Number: 20052518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 11/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2021
• 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
• Patient Sex: Unknown