• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

  • Print
  • Share
  • E-mail
-

Event Detail

Event ID 62733
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 2012-09-25
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY; and countries of: ARGENTINA, AUSTRALIA, BANGLADESH, BRAZIL, CALI COLOMBIA, CALLO PERU, GERMANY, GUAYQUIL ECUADOR, HONG KONG, INDIA, INDONESIA, JAPAN, LEBANON, MADRID SPAIN, MEXICO, NEW ZEALAND, SANTIAGO, SANTIAGO CHILE, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SRI LANKA, TAIWAN, THAILAND, and UNITED ARAB EMIRATES (UAE).

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 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: 16410 serial numbers:1001-1034,1036-1061,and 1602-1622. Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues. 81 Z-0285-2013
Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 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: 16409 serial numbers: 1001-1026 Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues. 26 Z-0284-2013
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 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: 16406 serial numbers: 1001-1004,1007-1055,1057-1310, 1648, 1649, 1657, 1822, and 1823. Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues. 312 Z-0283-2013
Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 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: 16405 serial numbers: 1001-1466. Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues. 466 Z-0282-2013
Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 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: 16401 serial numbers: 1001-1243, 1247-1648, 1650-1821, and 1824-3003. Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues. 1097 Z-0281-2013
Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 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: 16400 serial numbers: 1001-1141, 1143-1274,1333 Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues. 274 Z-0280-2013
-
-