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

Model Number FX821T

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

Investigation result: description of incoming product condition.The valve was received submersed in an unidentified liquid in a plastic container.Patient information: age: (b)(6) years.Weight: (b)(6) kg.Height: unknown.Gender: female.Date of implantation: (b)(6) 2020.Date of removal: (b)(6) 2020.Visual inspection: no significant deformations or damage of the valve were detected during the visual inspection.In the delivery liquid are visible deposits detected.Permeability test: a permeability test has shown that the valve is permeable.Adjustment test: the m.Blue 5 was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Computer controlled test: to investigate the claim of dysfunction, 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 valve operates within the accepted tolerance in both positions.Results: first we performed a visual inspection of the m.Blue 5.No significant deformations or damage of the valve were detected during the visual inspection.In the delivery liquid are visible deposits.Next we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The m.Blue 5 valve operates as expected and met all specifications.Finally, we have dismantled the valve.There were no visible deposits observed inside the valve.Based on our investigation, we are unable to substantiate the claim of occlusion and dysfunction.At the time of our investigation, the valve was operating within the specified tolerances.How the above-mentioned functional impairment occurred is not revealed to us at the time of the examination.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).No further regulatory actions are required from our point of view.

Event Description

It was reported that there was a problem with a m.Blue 5 valve.The surgeon suspected that the valve is blocked and that the valve adjusted itself.Patient information: implantation: (b)(6) 2020.Removal: (b)(6) 2020.Height: unknown.

• Brand Name: M.BLUE 5 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: 10320143
• MDR Text Key: 200249306
• Report Number: 3004721439-2020-00146
• Device Sequence Number: 1
• Product Code: JXG
• 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: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX821T
• Device Catalogue Number: FX821T
• Device Lot Number: 20047596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2020
• 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: 7 YR
• Patient Weight: 15