INTERMATE

Additional Manufacturer Narrative

CORRECTION: A1: PATIENT IDENTIFIER, B5, D1, D4 (MODEL, CATALOGUE, LOT, EXPIRATION DATE, UNIQUE IDENTIFIER, D10. H6 (UPDATE CODES), H11. D4: EXPIRATION DATE (REMOVE THE DATE AND UPDATE THE NULL VALUE TO NI). B5: UPDATE TO "IT WAS REPORTED THAT A LARGE VOLUME INTERMATE UNDERINFUSED DURING PATIENT INFUSION. THE ISSUE WAS FURTHER DESCRIBED AS THE UNSPECIFIED MEDICATION DID NOT INFUSE CORRECTLY." H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.