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

Model Number FX824T

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problem Hydrocephalus (3272)

Event Date 11/08/2023

Event Type  Injury  

Manufacturer Narrative

Investigation: visual inspection during the investigation, scratches on the outer housing of the valve, but no significant deformations or damage was determined.Permeability test a permeability test has indicated that the m.Blue valve is permeable.Computer controlled test to investigate the claim of under-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 the horizontal as well as the vertical positions.The results show that the m.Blue is operating within the accepted tolerance in the horizontal position, but not within the specified tolerances in the vertical position.An accelerated outflow of m.Blue could be determined.Adjustment test the m.Blue valve was tested and is partially adjustable (from 22 to 24 cmh2o).Braking force and brake function test the brake functionality test has shown that the brake function is operational, however the braking force cannot be measured due to the limited adjustability of the valve.Internal inspection after dismantling of the valve, deposits were found in m.Blue.Results based on our investigation results, we can determine an accelerated outflow in the valve.The determined deposits can be named as the cause for the accelerated outflow.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.

Event Description

It was reported that a m.Blue (#fx824t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the shunt system was believed to be operated in under-drainage and adjustment difficulties.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: 12 years height: 135 cm weight: 35 kg gender: female.

• Brand Name: M.BLUE PLUS SYS W/CONTROL RESERVOIR
• Type of Device: 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: 18312219
• MDR Text Key: 330295204
• Report Number: 3004721439-2023-00362
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00401906504830
• UDI-Public: 401906504830
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K192266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2023

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
• Device Operator: Health Professional
• Device Model Number: FX824T
• Device Catalogue Number: FX824T
• Device Lot Number: 20052916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR
• Patient Sex: Female
• Patient Weight: 35 KG