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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Event Detail

Event ID 62367
Product Type Devices
Status Ongoing
Recalling Firm Terumo Cardiovascular Systems Corporation
City Ann Arbor
State MI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-25
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide distribution: USA (nationwide) and countries including: Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 801764 and serial numbers: 0006-0066, 0100-0311, 0313-0322, 1001-1027, 1100-1434, 1436,1440, and1441. Class II Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. Occlusion malfunctions include stiff/difficult to adjust occlusion, loss of occlusion setting, unequal roller-to-roller occlusion and inability to adjust the occlusion. If it is necessary to replace a roller pump during cardiopulmonary bypass, the user must temporarily suspend cardiopulmonary bypass to replace the equipment or reassign a pump. In this situation, the potential for patient injury depends on the patient condition, the user's response to the malfunction, the criticality of the pump that is impacted (arterial, cardioplegia, sucker, vent) and the timing of the event (before, during, or after cardiopulmonary bypass) The potential patient injuries range from no injury to cellular death resulting in neurologic dysfunction, cardiac dysfunction due to inadequate myocardial protection, end organ dysfunction, or death in the case of an extended period of no flow. 648 units Z-1969-2012
System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 801763 and serial numbers: 0011-0335, 0337-0610, 1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, and 1447-1450. Class II Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. Occlusion malfunctions include stiff/difficult to adjust occlusion, loss of occlusion setting, unequal roller-to-roller occlusion and inability to adjust the occlusion. If it is necessary to replace a roller pump during cardiopulmonary bypass, the user must temporarily suspend cardiopulmonary bypass to replace the equipment or reassign a pump. In this situation, the potential for patient injury depends on the patient condition, the user's response to the malfunction, the criticality of the pump that is impacted (arterial, cardioplegia, sucker, vent) and the timing of the event (before, during, or after cardiopulmonary bypass) The potential patient injuries range from no injury to cellular death resulting in neurologic dysfunction, cardiac dysfunction due to inadequate myocardial protection, end organ dysfunction, or death in the case of an extended period of no flow. 992 units Z-1968-2012
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