Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an alternative to transplantation as destination therapy (DT) for patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD Pump Controller is a microprocessor unit that controls and manages HeartWare System operation. It sends power and operating signals to the blood pump and collects information from the pump. The controller requires two power sources for safe operation: either two batteries, or one battery and an AC adapter or DC adapter. While active, patients will typically use two batteries. While relaxing or sleeping, patients should use power from an electrical outlet (AC adapter) because it provides power for an unlimited period of time. The HeartWare Battery Charger is part of the HeartWare Ventricular Assist System (HVAD). Patients receive 4 total batteries with their system along with a battery charger and are instructed to have spare, fully charged batteries always available. The battery charger can charge up to 4 batteries at a time using 4 charging bays. Each battery slides into a bay and is connected to the battery charger.
Recall
- Recall Number
- Z-0582-2019
- Event Number
- 81609
- Firm
- Heartware, Inc.
- FEI Number
- 3007042319
- Product Code
- DSQ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 19, 2018
- Terminated
- July 21, 2020
- Address
- 14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807
Description
Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an alternative to transplantation as destination therapy (DT) for patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD Pump Controller is a microprocessor unit that controls and manages HeartWare System operation. It sends power and operating signals to the blood pump and collects information from the pump. The controller requires two power sources for safe operation: either two batteries, or one battery and an AC adapter or DC adapter. While active, patients will typically use two batteries. While relaxing or sleeping, patients should use power from an electrical outlet (AC adapter) because it provides power for an unlimited period of time. The HeartWare Battery Charger is part of the HeartWare Ventricular Assist System (HVAD). Patients receive 4 total batteries with their system along with a battery charger and are instructed to have spare, fully charged batteries always available. The battery charger can charge up to 4 batteries at a time using 4 charging bays. Each battery slides into a bay and is connected to the battery charger.
HVAD Battery Charger units manufactured with wrong inductors.
On November 2018 Medtronic sent the following letter to all their consignees: Dear Physician or Healthcare Professional: HeartWare, now a part of Medtronic, has been notified by an outside vendor that a quantity of HVAD battery charger units (see image above) may have been manufactured with an incorrect circuit component. This subset may exhibit one or more of the battery charging bays not fully charging the battery and/or battery charger indicators (LED) not lighting. The behaviors may occur in any individual bay, independent of the other charging bays. In analyzed units, up to 2 charging bays exhibited one of the above behaviors. In all cases, at least 2 of the remaining bays were able to continue to charge batteries as needed. We are not able to predict if, or when, one of the identified battery charger units may malfunction. The potential exists, however, that all circuits responsible for charging batteries and LED function may fail due to the incorrect component. In the population of potentially affected product, Medtronic has observed a malfunction rate of 16.7%. The number of potentially affected battery chargers remaining in distribution is estimated to be 2031 worldwide. These units were distributed between June 2017 and June 2018. Charging units outside of the serial numbers listed in Appendix A, all new manufactured battery chargers, and the individual batteries are not in scope of this advisory. Through November 02, 2018, Medtronic has received zero (0) reports of patient injuries associated with this issue. Patient Management Recommendations We realize that each patient requires unique clinical considerations. In consultation with Medtronics Independent Practitioner Quality Panel (IPQP), the following recommendations are provided: For patients with a HeartWare Battery Charging Unit in the identified list of Serial Numbers (refer to Appendix A): " Instruct patients to monitor the battery charging unit for any of the following beha
Worldwide distribution - US nationwide distribution in the state of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI. Countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Italy, Latvia, Lebanon, Netherlands, Poland, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
2031