EV1000 Clinical Platform, Models: EV1000A, EV1000NI… recallZ-1193-2019 · Edwards Lifesciences, LLC · initiated Mar 21, 2019

Why it was recalled

Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.

FDA root cause category: Use error

What the company is doing

On 03/21/19, Urgent Medical Device Safety Notification - Action Required notices were mailed to consignees. The firm strongly advised that consignees be cautious that IV bags and other fluids need to be positioned away from AC power connectors in order to avoid liquid ingress. In addition, consignees were asked to follow installation instructions in the operator's manual and to complete and return the response form. On 03/30/19, Urgent Medical Device Safety Notification - Action Required Addendum was mailed informing customers that if they require assistance they may call Technical Support is 800-822-9837. On 05/10/19, Urgent Medical Device Safety Notification - Action Required Addendum was mailed informing customers that improper mounting of the power supply could result in liquid ingress into the adaptor causing a short. Additional potential causes, are as follows: Reports of Burnt Cables: - We have reports of cables that appear burnt, without smoke, sparks or fire. We continue to investigate to identify all potential causes. One potential cause is the presence of conductive material in the AC inlet of the power supply. - Please assure that there is no conductive material in or near the AC inlet when connecting the AC power cord to the device power supply, and that both the AC power cord and inlet are clean and dry. Reports of Smoke, Sparks or Fire due to Cleaning or Decontamination/Disinfection: - The product instructions indicate that product should be kept dry and the cables should not be immersed in any liquid solution or liquids allowed to penetrate connectors. - Another opportunity for liquid ingress into the power supply could be the cleaning and disinfection process. Although the cleaning instructions in the Operators Manual indicate both to only wipe with a damp cloth and to dry the cable after cleaning, user reports indicate that this process is not always followed. - Please assure that the cleaning instructions as noted in the Oper

Recall details

Recall number

Z-1193-2019

Recall class

Class I (most serious)

Status

Terminated

Initiated by the company

Mar 21, 2019

Posted by the FDA

May 21, 2019

Recalling firm

Edwards Lifesciences, LLC

Quantity

22443

Product code

DXN

FDA submissions

K160552

Distribution

Worldwide Distribution - US Nationwide : FL, MD, NY, TX, VA, CO, OK, MO, CA, DE, TN, NC, DC, PA, MA, OR, SC, OH, WI, KS, NV, MI, IL, KY, GA, NJ, WA, CT, IN, MN, WV, LA, MS, AL, SD, NE, IA, AZ, ID, HI, UT, ME,MT, NM, AK, NH, RI, AR, ND, WY, PR. Foreign (OUS): IT, FI, CO, KR, JP, PL, BE, GR, NL, IL, AT, DK,CA, GB, BR, SA, SE, DE, AU, FR, MX, IN, IC, ZA, ES, TR, NZ, MY, IE, SG, CZ, SI, PT, CH, RE, LK, CR, AR, HK, NO, PY, PA, MT, EG, NP, TN, RU, RO, NA,CL, BH, IR, PH, TH, KZ, DZ, BG, EE, KW, VN, OM, PE, EC, AE, MA, VE, BO, QA, DO, GT, BY, JO, LT, SK, HU, CY, MN, TW, CN

Product description

EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume View sensor).

Other devices under the same FDA submission

3 devices cleared under K160552 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• EV1000 EVPMP

  Edwards Lifesciences LLC · SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
  1 report
• CLEARSIGHT CSCS

  Edwards Lifesciences LLC · PLETHYSMOGRAPH, IMPEDANCE
  1 report
• CLEARSIGHT CSCM

  Edwards Lifesciences LLC · SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
  1 report