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.
This recall has been terminated (originally issued April 23, 2012).
- Recall Initiated
- March 21, 2012
- Posted
- April 23, 2012
- Terminated
- July 11, 2013
- Recall Number
- Z-1452-2012
- Quantity
- 3,022
- Firm Location
- Ann Arbor, MI
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
Worldwide Distribution - USA including 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 , ND, NE, NH, NJ, NM , NY, OH , OR, PA , RI, SC , TN, TX , VA, WA , WI, WV, WY, and Puerto Rico and the countries of PERU, Philippines, REPUBLICA, SANTIAGO, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tujunga, United Arab Emirates, Uruguay, Venezuela, Vietnam, Wooddale, and Yemen.
Lot / Code Info
Catalog Number 16413; Lot numbers/serial numbers: 1, 2, 3, 246546, 249510, 249511, 249647, 254871, 258279, 263615, 270671, 273712, 274258, 278324, 280640,285001, 290027, 294434, 295965, 301085, 305999, 308323, 316251, 320749, 325181, 326988, 329131, 332078, 332292, 333714, 336835, 337478, 340618, 343974, 348433, 355116, 355594, 358380, 362038, 363388, 367158, 375588, 379930, 381111, 385518, 389149, 392758, 393294, 400090, 400091, 401120 401121, 401127, 401832, 401885, 402285, 402404, 403219 403611, 403717, 404052, 404360, 404929, 405141, 405324, 405558, 405569, 405719, 405855, 406498, 406716, 406781 407341, 407342, 407501, 407639, 407793, 408201, 408359 408600, 409098, 409104, 409291, 409302, 409570, 409755, 410056, 411301, 411699, 412209, 413388, 413575, 413992, 414974, 415022, 415379, 415605, 415844, 416787, 418180 418289, 418482, 418915, 419276, 419555, 419935, 420558 420782, 420850, 421705, 421939, 421941, 422214, 422498 422990, 423664, 425424, 428898, 435660, 439119, 441511 443513, 447675, 448720, 453531, 457904, 461150, 463168 466017, 467449, 469356, 478255, 479117, 483184, 483633, 487810, 91429006, 93323004, 93355004, 93355005 94025004, 94095004, 94095005, 94116005, 94129005, 94129006, 94143005, 94143006, 94186005, 94186006, 94200005, 94200006, 94207006, 94221006, 94256006, 94283006, 94290006, 94297006, 94304006, 94322006, 94339006, 95009006, 95048006, 95061006, 95072006, 95093006, 95101006, 95108006, 95114006, 95124006, 95179006, 95194006, 95219006, 95265006, 95279006, 95300006, 95310006, 95339006, 95363006, 96036006, 96086006, 96102006, 96113007, 96143008, 96162008 96187008, 96193008, 96200008, 96236008, 96250008, 96262008, 96277008, 96295008, 96316008, 96331008, 96338008, 96348008, 96353008, 97006008, 97007008, 97015008, 97017008, 97073008, 97122008, 97133008, 97139008, 97161008, 97168008, 97175008, 97223008, 97238008, 97252008, 97279008, 97286008, 97300008, and W417301.
Root Cause
Device Design
Action Taken
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.