MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG M.BLUE 0 VALVE; HYDROCEPHALUS MANAGEMENT

Model Number FX800T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

Height: 105cm.When additional information becomes available a follow up report will be submitted.

Event Description

It was reported that the valve is over draining.The reporter indicated that a post-operative valve was over draining.This was icp verified.Per the reporter the patient has had mutliple shunt revisions.Additional information has not been provided.

Manufacturer Narrative

Investigation: visual inspection: the visual inspection revealed scratches on the outer housing but no further significant damage to the m.Blue.Permeability test: to proof the penetrability of the valve we have carried out penetrability test.This test is carried out at a hydrostatic pressure of approximately 20- 30 cmh2o in the direction of flow.The test shows that the valve is permeable.Adjustment test: our adjustment tests are carried out with the standard checkmate and measurement tool.The valve is adjusted from 0 to 40 cmh2o and down again in increments of 4cmh2o.The valve is adjustable to all settings.Braking force and brake function test: to measure the braking force, we tested the m.Blue with a braking force apparatus.Here it is measured how much force must be exerted on the housing to release the rotor to adjust the valve by the integrated magnet of the braking force apparatus.The investigation of the braking force showed that the function is fully functional and the braking force is within the given tolerance.Computer controlled test: the test is performed with a miethke computer controlled testing apparatus.The valve is tested by simulating a cerebrospinal fluid flow at rates with the m.Blue in vertical position (in acc.To iso 7197).Distilled water is used as the test-liquid.The opening pressure is expected to measure at 0 ± 4 cmh2o in the vertical position.The pressure range was set to 0 cmh20.The opening pressure of 1.5 cmh2o was measured at a flow rate of 20 ml/h.The value is within the tolerance.At the set pressure range of 40 cmh20, an opening pressure of 25 cmh2o at a flow rate of 20 ml/h was measured.The value is 7 cmh2o lower than the tolerance and thus possibly operates in over- drainage.Results: first, we performed a visual inspection of the m.Blue.The optical inspection revealed scratches on the outer housing.Next, we tested the permeability of the valve.The test result show that the valve is permeable.To ensure that the m.Blue is adjustable we tried to adjust the valve from 0 cmh2o to 40 cmh2o and down again in increments of 4 cmh2o.The valve was adjustable to all settings.Next, we tested the braking force and brake functionality.The results show that the brake function is fully operational and the braking force is within the given tolerances.We carried out a computer-controlled test in the research & development department: the valve was subjected to a pressure/flow performance bench test following the previously described investigations.As a result, we could not detect any blockage in the valve, but in the pressure setting of 40 cmh2o the valve operates in tendency to over- drainage.In order to verify whether the valve was compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood or tissue particles) one in the cerebrospinal fluid, we have finally opened the valve.Inside the m.Blue valve, we detected slightly build-up of substances (likely protein) inside the valve.Based on our investigations, we did not detect a blockage of the valve at the time of the examination.We suspect that the observed deposits may have temporarily affected the flow function of the valve.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.We can exclude a defect at the time of release.The m.Blue met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.Further actions: no further actions are required from our point of view.

• Brand Name: M.BLUE 0 VALVE
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9448425
• MDR Text Key: 170330599
• Report Number: 3004721439-2019-00296
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K141687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX800T
• Device Catalogue Number: FX800T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Date Manufacturer Received: 11/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Weight: 15