THERE WAS NO PATIENT INVOLVEMENT. AT THE DATE OF THE PRESENT REPORT, THE UNIT HAS NOT BEEN RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. THE BMR 1900 L PHISIO WAS ASSEMBLED INTO A CUSTOMIZED PRODUCT (CATALOG NUMBER IN00197) THAT IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE BMR 1900 L PHISIO VENOUS RESERVOIR BAG (CATALOG NUMBER 00398), WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K112771). SORIN GROUP (B)(4) MANUFACTURES THE BMR 1900 L PHISIO. THE INCIDENT OCCURRED IN (B)(6). (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE OUTLET CONNECTOR OF THE VENOUS RESERVOIR BMR 1900 L PHISIO BROKE OFF FOLLOWING A PROCEDURE. AS THE EVENT OCCURRED AFTER THE PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.
D
Patient 1
SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE OUTLET CONNECTOR OF THE VENOUS RESERVOIR BMR 1900 L PHISIO BROKE OFF FOLLOWING A PROCEDURE. AS THE EVENT OCCURRED AFTER THE PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT.
N
Patient 1
SORIN GROUP (B)(4) MANUFACTURES THE BMR 1900 L PHISIO. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE OUTLET CONNECTOR OF THE VENOUS RESERVOIR BMR 1900 L PHISIO BROKE OFF FOLLOWING A PROCEDURE. AS THE EVENT OCCURRED AFTER THE PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINED UNIT WAS RETURNED TO SORIN GROUP (B)(4) FOR FURTHER INVESTIGATION WHERE IT UNDERWENT VISUAL INSPECTION. THE INSPECTION FOUND THAT THE BREAKAGE OF THE CONNECTOR SEEMED TO OCCUR AS A RESULT OF AN UNUSUAL TEAR-DOWN OPERATION DONE IN AN ORTHOGONAL DIRECTION WITH RESPECT TO THE BACKPLATE. USE SIMULATION SUGGESTED THAT THE FORCE TO INDUCE BREAKAGE IS SIGNIFICANTLY HIGHER THAN THE NORMAL FORCE APPLIED TO SET-UP AND TEAR-DOWN THE BAG TO AND FORM THE BRACKET. IN ORDER TO IMPROVE THE RESISTANCE OF THE CONNECTORS TO MECHANICAL STRESS, A CAPA WAS INITIATED AND THE LENGTH OF THE PVC TUBING HAS BEEN INCREASED BY 4MM. THIS CHANGE PERMITS A REDUCTION OF THE PULL FORCE TO BE APPLIED TO THE CONNECTORS DURING THE SET-UP AND TEAR-DOWN OF THE BAG WITHOUT IMPACTING THE POSITIONING OF THE BAG ONTO THE BRACKET. AN ADDITIONAL CAPA WAS ALSO INITIATED TO GUARANTEE A CORRECT DISTRIBUTION OF THE SOLVENT DURING THE GLUING PHASE. TO ACHIEVE THIS, A SEMI-AUTOMATIC EQUIPMENT WHICH AVOIDS EXCESSIVE DISTRIBUTION OF THE BONDING AGENT WAS INTRODUCED IN THE MANUFACTURING AREA IN MARCH, 2016. THE INVOLVED UNIT WAS MANUFACTURED BEFORE IMPLEMENTATION OF THE ABOVE CORRECTIVE ACTIONS.
MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL