Sarns Modular Perfusion System 8000 Catalog number 148689 or 78-8067-3878-3 Temperature-Pressure Board, Cardioplegia Monitor (service part only) The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps.
Recall
- Recall Number
- Z-1452-2012
- Event Number
- 60774
- Firm
- Terumo Cardiovascular Systems Corporation
- FEI Number
- 1828100
- Product Code
- DTQ
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- March 21, 2012
- Posted
- April 23, 2012
- Terminated
- July 11, 2013
- Address
- 6200 Jackson Road, Ann Arbor, MI, 48103-9586
Description
Sarns Modular Perfusion System 8000 Catalog number 148689 or 78-8067-3878-3 Temperature-Pressure Board, Cardioplegia Monitor (service part only) The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps.
Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation, the malfunctions are caused by or could have been caused by soldering anomalies on the circuit board of the monitor. The compromised solder joints could cause intermittent or loss of display, or could cause monitor reset, po
TERUMO sent an URGENT MEDICAL DEVICE RECALL- SAFETY ADVISORY to all consignees on March 21, 2012 via Federal Express. Terumo issued the safety advisory to remind users how to intervene if they experienced intermittent or complete loss of pressure display on the arterial monitor or cartiplegia monitor, or a related pump stop. Customers were asked to review the Medical Device Correction notice, assure that all users are aware of the notice, confirm receipt of the communication by faxing the attached Customer Response Form to 1-800-292-6551. For questions regarding this recall call 1-800-521-2818.
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