Patient information was not provided.The model and serial number of the pump were not provided, and the unique identifier (udi) number could not be determined.This information will be provided in a supplemental report of and when made available.As the serial number was not provided, the date of manufacture could not be determined.This information will be provided in a supplemental report of and when made available.Sorin group (b)(4) manufactures the s3 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).A sorin group field service representative worked with the customer and provided instruction for how to remove and clean the roller.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.
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Additional device information: model number: 10-60-00, serial number: (b)(4).Device manufacture date: 11/15/2005.Sorin group (b)(4) manufactures the s3 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Through follow-up communication with the customer on november 17, 2016, sorin group deutschland learned the model and serial number of the involved pump (model 10-60-00 serial number (b)(4)).Communication with the sorin group field service representative on november 22, 2015 revealed that the issue was related to the white tubing guide rollers.
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