It was discovered via facility medwatch report ((b)(4)) that the following was reported: "the surgeon has concerns that the arthrex pump that was used in the surgery was not calibrated to deliver the correct amount of fluid, causing swelling in the patient's quadriceps muscle.Preventative & corrective maintenance records were reviewed as well as the manufacturers guidelines of use.The pump was used as directed.Upon receiving this concern, the pump was tested against factory specifications with the following results @ 10% flow: pressure set: 35, 50, 75, 100, 120.Display: 77, 110, 165, 220, 264.Actual: 82, 116, 174, 229, 274.Per (facility) biomed department, these readings are within the manufacturer's specifications.The pump has been sequestered and the remaining pumps will be exchanged by the manufacturer.Procedure was a knee arthroscopy.Original intended procedure was a knee arthroscopy.This patient required a repeat knee arthroscopy for an infected joint." approximate age of device: 11 years this same pump was also used in two additional cases which have been reported via facility medwatch reports: medwatch (b)(4) (arthrex reference: (b)(4)) and medwatch (b)(4) (arthrex reference: (b)(4)).Additional information obtained 5/22/2019 from sales rep: the facility pumps have since been exchanged due to pump age and the exchanged pumps were no longer under contract.Additional information obtained 5/30/2019 from facility: date of procedure was (b)(6) 2019.Patient issue did not occur during the procedure.On (b)(6) 2019 patient was seen outpatient for left thigh hematoma.The swelling was removed with an ultrasound guided needle biopsy.Patient was brought into the or on (b)(6) 2019 for a left knee arthroscopic washout and then admitted.Patient was discharged on (b)(6) 2019.The tubing used with the pump was part number ar-6410.The pump was sequestered after (b)(6) 2019.Patient was confirmed to have staphylococcus aureus which was discovered on (b)(6) 2019.Tubing disposition is unknown.
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