A facility reported a shunt infection post implantation.The patient was implanted with a hakim programmable valve on (b)(6) 2021 after injuries sustained from a severe car accident.It was reported after the procedure the silicone valve was broken out and the patient developed an infection.The signs and symptoms of the infection included high fevers and nuchal rigidity, and a cerebral spinal fluid cell count of cell count 1000+.The patient was treated with antibiotics and the product was explanted on (b)(6) 2021 and replaced with the valve of another company.In regard to the patients current status, it was reported the ¿infection is getting worse and the relatives gave up the treatment.¿.
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Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The hakim valve was returned for evaluation.Device history record (dhr) - review of the history device records for the product code 823832 with lot 4218862 conformed to the specifications when released to stock failure analysis - the valve was visually inspected, a tear/cut was noted in the silicone housing from the end of the valve casing to the end of the siphon guard.The position of the cam when valve was received was 140mmh2o.The valve was then pressure tested according to test method the valve failed the test, due to the tear/cut in the silicone housing.The siphon guard was visually inspected, and cut/scratch marks were noted on the siphon guard.The root cause for the tear/cut in the silicone housing reported by the customer is probably due to a sharp or pointed object coming into contact with the silicone housing, as noted in the ifu silicone has a low tear/cut resistance.The cut/scratch marks in the siphon guard are due to a sharp or pointed object coming into contact with the siphon guard.The possible root cause for the infection issue, could be linked to the patient and hospital surroundings.As no discrepancies were found with the sterilization certificate.
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