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

Model Number FX804T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hydrocephalus (3272)

Event Date 09/08/2021

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 plus (part # fx804t) was implanted during a procedure performed on (b)(6) 2021.According to the complainant, the shunt system 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: 178 centimeters (cm), weight: (b)(6), gender: male.

Manufacturer Narrative

Manufacturing and quality control data the m.Blue plus® was manufactured by a qualified employee on (b)(6) 2020.Deviations during assembly did not occur.The product was finally tested as article fx804t and released for packaging and sterilization and was sterilized by miethke.The m.Blue plus® 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 (b)(4) 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.The adjustable gravitational unit of the valve was pre-adjusted to 20 cmh2o in accordance with the specification.All tested parameters were assessed according to specifications.Investigation the following observations were made during the visual inspection: - no visual defects detected.Permeability test the test showed that the m.Blue plus® is permeable.Computer control test the both valve operating within the specified tolerance adjustability test the m.Blue® and the progav® 2.0 were found to be adjustable to all pressure settings.Braking force and brake function test the braking force of the gravitational unit of the both valves were within the specified tolerance and the brake function operated as expected.Internal inspection of product after dismantling of the valves, no deposits were found in both valves.

Event Description

Investigation is completed.

• Brand Name: M.BLUE PLUS VALVE
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12537568
• MDR Text Key: 275134410
• Report Number: 3004721439-2021-00274
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906504793
• UDI-Public: 4041906504793
• 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: FX804T
• Device Catalogue Number: FX804T
• Device Lot Number: 20050895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Weight: 61