MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PRECHAMBER PED.; HYDROCEPHALUS MANAGEMENT

Model Number	FV035T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection during the investigation, no significant deformations or damage of the product was determined.Permeability test: a permeability test has shown that the pediatric prechamber was permeable.Results: for the sake of completeness and transparency, we would like to point out that a permeability test was already performed at the hospital after the revision.Based on our examination results, we cannot determine any functional deviation at the returned product.How the aforementioned functional impairment occurred is not clear to us at the time of the examination.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a ped.Prechamber (part # fv035t) was believed to be operating in underdrainage.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the dysfunction.Age: 16 years, 11 months.Height: 150 centimeters (cm).Weight: 40 kilograms (kg).Gender: female.

• Brand Name: PRECHAMBER PED.
• 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: 17312787
• Report Number: 3004721439-2023-00187
• Device Sequence Number: 6638477
• Product Code: JXG
• UDI-Device Identifier: 04041906117603
• UDI-Public: 4041906117603
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K011030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2023

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
• Operator of Device: Health Professional
• Device Model Number: FV035T
• Device Catalogue Number: FV035T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 16 YR
• Patient Sex: Female
• Patient Weight: 40 KG