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 Hydrocephalus (3272)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported that a m.Blue (part # fx800t) was implanted during a procedure performed in on (b)(6) 2021.According to the complainant, the valve was believed to be operating in under-drainage.The patient underwent a revision procedure on (b)(6) 2021.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6).Height: 164 centimeters (cm).Weight: (b)(6).Gender: female.

Event Description

Investigation is completed.

Manufacturer Narrative

Manufacturing and quality control data the m.Blue® was manufactured by a qualified employee on (b)(6) 2021.Deviations during assembly did not occur.The product was finally tested as article fx800t and released for packaging and sterilization and was sterilized by miethke.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.All tested parameters were assessed according to specifications.Visual inspection the following observations were made during the visual inspection: - no visible defects detected.Permeability test the test showed that the m.Blue® is permeable.Computer control test this valve operated in the vertical position not within the specified tolerance (under-drainage).Adjustability test the m.Blue® was found to be adjustable to all pressure settings.Braking force and brake function test the braking force of the gravitational unit of the m.Blue® was within the specified tolerance and the brake function operated as expected.Internal inspection of product after dismantling of the valve, no visible deposits were found in m.Blue®.Results based on our investigation results, we can identify an "accelerated outflow" on the valve.It is possible that deposits were removed by our tests with liquid.Even non-visible deposits inside the valve can affect the function of the valve.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Small amounts of non-visible deposits/proteins might be compromise the integrity of the valve.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.

• Brand Name: M.BLUE 0 VALVE
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12537630
• MDR Text Key: 276848703
• Report Number: 3004721439-2021-00276
• Device Sequence Number: 1
• Product Code: JXH
• UDI-Device Identifier: 04041906504397
• UDI-Public: 4041906504397
• Combination Product (y/n): N
• PMA/PMN Number: K192266
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• 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
• Device Lot Number: 20052719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 52