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

Model Number	FX816T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: in the first step of our investigation, we performed a visual inspection of the product.We have checked for possible damage, deformations of the housing or other abnormalities.The following observations were made during the visual inspection: - scratches of the housing permeability test: the permeability test was performed at a hydrostatic pressure difference of the pressure setting of the m.Blue upon receipt plus 30 cmh2o in the horizontal direction of flow.The test showed that the m.Blue is permeable.Computer control test: to check the flow rate of the valve, the valve was tested on a miethke computer controlled testing apparatus and passed the standard test.The flow of the test liquid was reduced step by step from 60 ml/h to 5 ml/h (in accordance with iso 7197).Distilled water was used as the test-liquid.The resulting pressure was measured.The computer controlled test showed the opening pressure of the differential unit of the valve, at a reference flow rate of 20 ml/h in a horizontal position of the valve, to be 8,98 cmh2o.This is not within the specified tolerance of 5 cmh2o ± 3 cmh2o.Additional testing confirms the first test results.According to our results, we can detect a presence of a slowed outflow.Additionally, the gravitational unit of the valve was tested according to standard procedure in the vertical position.The results indicated that at a reference flow of 20 ml/h in the vertical position, the gravitational unit of the m.Blue® had a pressure of 29,99 cmh2o.This is within the specified tolerance of 25 cmh2o +6/ -12 cmh2o.Adjustability test: in this step, it was investigated whether the adjustable m.Blue can be successfully set to each specified pressure setting.It was checked whether the valve is fully adjustable within the full range of specified pressure settings (in increments of 4 cmh2o).The m.Blue was found to be adjustable to all pressure settings.Braking force and brake function test: the braking force and brake function test investigates whether the brake function of the adjustable valves is present and how much force must be exerted on the housing to release the rotor to adjust the valves using the integrated magnet of a specific measurement apparatus of braking force.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: in order to verify whether the investigated valve was compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, the valve is finally opened with a special tool.After dismantling of the valve, deposits were found in m.Blue.For more detailed visibility, the proteins/deposits in m.Blue were coloured by using a colouring solution.[colouring solution consisting of coomassi brilliant blue r mixed with 0.6% ethanol and distilled water].Results: based on the results of our investigation, we found that at the time of our testing, there was a slower discharge in the horizontal position of the valve, and in the vertical position, the discharge was within tolerance.Existing deposits in the csf can temporarily impair the function of the valve and is described as concomitant symptoms in hydrocephalus therapy.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.Further actions: from our point of view, no further regulatory actions are required.Return of product: we will return the investigated product to the sending clinic for our own relief.
Event or Problem Description
It was reported that a m.Blue (part # fx816t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the system was believed to be operated in over-drainage and non-adjustable.The patient underwent a revision procedure performed on (b)(6) 2023.The complaint device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 65 years weight: 63 kilograms (kg) height: 171 centimeters (cm) gender: unknown.

• Brand Name: M.BLUE 5 SYS W/PED.CONTROL RESERVOIR
• Common Device Name: HYDROCHEPHALUS 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: 16746094
• Report Number: 3004721439-2023-00072
• Device Sequence Number: 3429274
• Product Code: JXG
• UDI-Device Identifier: 04041906504526
• UDI-Public: 4041906504526
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K192266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2023

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
• Device Model Number: FX816T
• Device Catalogue Number: FX816T
• Device Lot Number: 20061192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• 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: 65 YR
• Patient Sex: Unknown
• Patient Weight: 63 KG