HEMOCONCENTRATOR BC 60 PLUS, BC 140 PLUS

Additional Manufacturer Narrative

MAQUET CARDIOPULMONARY REQUESTED THE PRODUCT BACK FOR MANUFACTURER INVESTIGATION. DURING VISUAL INSPECTION OF THE PRODUCT, A DEFECTIVE FIBER WAS DETECTED.BASED ON THIS FAILURE COULD BE CONFIRMED. SAP TREND SEARCH WAS PERFORMED (PRODUCT HEMOCONCENTRATOR AND FAILURE CODE DIRTY/FOREIGN PARTICLE): (B)(4) ADDITIONAL COMPLAINTS WERE RECORDED WITHIN THE LAST 12 MONTHS. RECENT SALES NUMBERS FROM (B)(6)2018 TO (B)(6)2019 :(B)(4) PIECES CALCULATED OCCURRENCE RATE: (B)(4) THE OCCURANCE RATE IS BELOW (B)(4) - DUE TO THIS INFORMATION NO SYSTEMIC ISSUE COULD BE DETERMINED AT THIS TIME. GETINGE CP ANTALYA HAS BEEN INITIATED SCAR #751001239 BASED ON THE FAILURE. SCAR HAS BEEN CLOSED SINCE SUPPLIER EVALUATED THE ISSUE AND CONFIRMED THE FAILURE. CAUSE OF THE FAILURE ACCORDING TO THE SUPPLIER IS SLIP DURING VISUAL INSPECTION AS A CORRECTIVE ACTION, INFORMATION ABOUT THE COMPLAINT GOES TO THE RESPONSIBLE DEPARTMENT.FURTHER ACTIONS WILL BE TAKEN IN PROCESS OF CONTINUOUS IMPROVEMENT.

Description of Event or Problem

REF.: #(B)(4).CUSTOMER REF.: (B)(4).

Additional Manufacturer Narrative

(B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). REFERENCE EXEMPTION # E2018002.

Description of Event or Problem

DURING THE SCHEDULED SURGERY, THE CUSTOMER DETECTED THE BLOOD LEAKING AT THE DRAINAGE SIDE. DURING THE EXTRACORPOREAL CIRCULATION, IT WAS OBSERVED THAT THE COLOR OF THE FILTRATED LIQUID WAS TURNING RED AS SOON AS THE FILTRATION STARTED. THE COLOR OF THE FILTRATED LIQUID WAS GETTING DARKER (REDDER) AND THE BLOOD LEAK WAS CONFIRMED. A REPLACEMENT WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS ON THE PATIENT. (B)(4).