(b)(6).Prismaflex st100 set c has been temporarily approved for use in the us under emergency use authorization (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.The actual sample was not available for investigation.However, photos of the impacted unit were provided.The visual inspection of the provided pictures showed that the dialysate port was cracked.The reported condition was verified.The observed damage is typical of mechanical shock applied on the product leading to its breakage.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
|