VENOUS BUBBLE TRAP (VBT)

Additional Manufacturer Narrative

MAQUET CARDIOPULMONARY (B)(4) REQUESTED THE PRODUCT BACK FOR INVESTIGATION AND RECEIVED IT ON 06/24/2016. OUR CUSTOMERS NEED TO FILL OUT A DECLARATION OF INFECTION RISK. IF THIS DOCUMENT IS NOT RECEIVED WE ARE NOT ABLE TO INVESTIGATE THE PRODUCT. IN CASE # (B)(4) THE HOSPITAL DID NOT FILL OUT THE DECLARATION OF INFECTION RISK COMPLETELY DUE TO GIVEN LAW IN THE (B)(6) THEY ARE NOT ALLOWED TO FILL OUT A SECTION. THEREFORE, THE SAMPLE COULD NOT INVESTIGATED BY OUR LABORATORY. ON THE OTHER HAND, DEVICE HISTORY RECORD OF THE COMPLAINED LOT HAS BEEN REVIEWED BY MAQUET CARDIOPULMONARY (B)(4) AND NO ABNORMALITY WAS FOUND FOR THE RELATED MATERIAL. ALL THE CONTROLS WERE DONE ACCORDING TO THE PROCESS CONTROL FORM, ALSO, IT WAS CONTROLLED THAT THE LEAKAGE TEST IN THE VBT PRODUCTION WAS PERFORMED. A SAP TREND SEARCH HAS BEEN PERFORMED (SEARCH FOR MATERIAL AND COMPONENT NUMBER 70103.0118, ERROR MESSAGE: 1000) WHICH CAME TO FOLLOWING RESULT: NO ADDITIONAL COMPLAINT WERE RECORDED. BASED ON THIS, A CONFIRMATION OF THE FAILURE BASED ON PREVIOUS COMPLAINTS IS NOT POSSIBLE, AND THERE IS NO SYSTEMIC ISSUE INDICATED.

Description of Event or Problem

(B)(4).

Additional Manufacturer Narrative

(B)(4). MAQUET CARDIOPULMONARY (B)(4) REQUESTED THE PRODUCT BACK FOR INVESTIGATION AND RECEIVED IT ON 06/24/2016. DEVICE HISTORY RECORD OF THE COMPLAINED LOT HAS BEEN REVIEWED BY MAQUET CARDIOPULMONARY (B)(4). THEREBY NO ABNORMALITY WAS FOUND FOR THE RELATED MATERIAL. ALL THE CONTROLS WERE DONE ACCORDING TO THE PROCESS CONTROL FORM, ALSO, IT WAS CONTROLLED THAT THE LEAKAGE TEST IN THE VBT PRODUCTION WAS PERFORMED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

DESCRIPTION FROM THE CUSTOMER REPORT: "NOT ABLE TO SUCK THE COLLECTED AIR ON TOP OF THE VENOUS BUBBLE TRAP ON THE USUAL WAY. THEY FINALLY MANAGED TO DO THIS MANUALLY WITH A SYRINGE" (B)(4).