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

Model Number FX816T

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

Patient Problem Hydrocephalus (3272)

Event Date 10/19/2023

Event Type  Injury  

Manufacturer Narrative

Investigation: visual inspection: during the investigation, no significant deformations or damage of the valve was determined.Permeability test: a permeability test has shown that all components are permeable.Computer control test: to investigate the claim of over- drainage, the opening pressure is measured using a miethke computer control 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 not adjustable.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 non-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 at the m.Blue an accelerated outflow and adjustment difficulties.The determined deposits can be named as the cause for the accelerated outflow and the non-adjustability.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 (#fx816t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the valve was believed to be operated in overdrainage and had 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: 1 year, 9 months, height: 90 cm, weight: 11.5 kg, gender: female.

• Brand Name: M.BLUE 5 SYS W/PED.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: 18130535
• MDR Text Key: 328038273
• Report Number: 3004721439-2023-00342
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906504526
• UDI-Public: 4041906504526
• 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: 11/14/2023

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: FX816T
• Device Catalogue Number: FX816T
• Device Lot Number: 20053077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2021
• 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: 1 YR
• Patient Sex: Female
• Patient Weight: 11 KG