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

Model Number	FX819T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information /investigation will be submitted in a supplemental report.
Event or Problem Description
It was reported that a m.Blue plus (# (b)(4)) was implanted during a procedure performed on an unspecified date.According to the complainant, the shunt system was believed to be operating in underdrainage and difficult to adjust.The patient underwent a revision procedure.No patient complications were reported as a result of the revision procedure.Age: (b)(6), height: unknown, weight: (b)(6) kg, gender: female.
Additional Manufacturer Narrative
Investigation: visual inspection: dried deposit in the ped.Controlreservoir were observed through the visual inspection.No significant deformations or damage were detected.Permeability test: a permeability test has indicated that all components have blockages.Computer controlled test: not applicable.Adjustment test: the m.Blue was tested and is adjustable to all specified pressures.The progav® 2.0 was tested and is not adjustable.Klick force and brake function test m.Blue: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Progav 2.0: 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 valves, deposits were found in both valves results: it should be noted that the product was received dry (i.E.Not submersed in liquid as recommended).The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.Based on our test results, we can determine a blockage of both valves as well as a non-adjustability on the progav 2.0 valve at the time of our investigation.We are assuming that the deposits detected within the valves have caused the functional impairment.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 compromise the integrity of the valve.We can exclude a defect at the time of release.The shunt system 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.

• Brand Name: M.BLUE PLUS SYS W/PED.CONTROL RESERVOIR
• Common Device Name: 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: 13176959
• Report Number: 3004721439-2021-00356
• Device Sequence Number: 4561607
• Product Code: JXG
• UDI-Device Identifier: 04041906504526
• UDI-Public: 4041906504526
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/09/2025
• Device Model Number: FX819T
• Device Catalogue Number: FX819T
• Device Lot Number: 20049313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 MO
• Patient Sex: Female
• Patient Weight: 6 KG