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

Model Number FX805T

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

Investigation results: visual inspection: the product showed clearly signs of mould and slightly scratches on the housing.Additional are visible deposits in the outlet spout.Permeability test: the test showed that the m.Blue 10 is permeable.Computer controlled test: the computer controlled test has shown the opening pressure of the m.Blue 10, at a reference flow rate of 20 ml/hr in a horizontal position, to be 8.37 cmh2o.This is within the specified tolerance of 10 cmh2o ± 3 cmh2o.Additionally, the m.Blue 10 was tested according to standard procedure in the vertical position.At an opening pressure of 8 cmh2o in the vertical position, a pressure of 15 cmh2o ± 9 cmh2o is expected.The results indicated that at a reference flow of 20 ml/hr in the vertical position, the m.Blue 10 had a pressure of 10.14 cmh2o.This is within the specified tolerance of 15 cmh2o ± 9 cmh2o.Adjustability test: the m.Blue 10 was found to be adjustable to all pressure settings.Braking force and brake function test: the braking force of the m.Blue 10 ® was within the specified tolerance and the brake function operated as expected.Internal inspection of product: after dismantling of the valve, some deposits were found in m.Blue 10.Results: based on our investigation, we are not able to substantiate the claim of "non- adjustability" or "blockage".However, we assume that the significant deposits found within the valve may have temporarily 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.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).From our point of view, no further regulatory actions are required.

Event Description

It was reported that there was a problem with a m.Blue valve."shunt working but non adjustable." implantation: (b)(6) 2019.Removal: (b)(6) 2020.Patients information : height and gender are not available.

• Brand Name: M.BLUE 0 VALVE W/PERITONEAL CATHETER
• Type of Device: 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: 10430520
• MDR Text Key: 203646742
• Report Number: 3004721439-2020-00169
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K192266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2020

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 Operator: Health Professional
• Device Expiration Date: 11/22/2022
• Device Model Number: FX805T
• Device Catalogue Number: FX805T
• Device Lot Number: 20039979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR
• Patient Weight: 4