There was no patient involvement.The serial number was not provided and the unique identifier (udi) number could not be determined.This information will be provided in a supplemental report if and when made available.Mfg date: as the serial number was not provided, the manufacture date could not be determined.This information will be provided in a supplemental report if and when made available.Sorin group (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that the s5 roller pump went into pressure control mode during priming, even though the pressure was normal.There was no patient involvement.A sorin group field service representative followed-up with the customer regarding this issue and discovered that the user had set the incorrect control limit.The customer stated that the device was set to 50mmhg instead of 500mmhg, resulting in the reported issue.The investigation is on-going.A follow-up report will be submitted when the investigation is complete.
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