FRAMINGHAM, Mass., June 8, 2015 /PRNewswire/ -- HeartWare International, Inc. (NASDAQ: HTWR) issued a voluntary Urgent Medical Device Correction on May 11, 2015, describing five different types of complaints reviewed as part of HeartWare's ongoing product performance monitoring. The notice provides information to reinforce proper performance and safe use of the HeartWare® Ventricular Assist System to help reduce the potential occurrence of avoidable patient injury. In letters to clinicians and patients, the company reminds patients with HeartWare System product codes 1101 and 1103 to follow directions in the Patient Manual and to be aware of certain signs of wear. Specifically, the notice calls attention to the following points:
- Maintaining Continuous Power Supply – The notice reminds patients never to disconnect the HVAD® Pump from both power sources at the same time. The HVAD® controller has an internal battery with the sole purpose of powering a "double disconnect alarm" in the unlikely event that both power sources are simultaneously disconnected. Like all batteries, this battery may degrade with age. If there is a complete interruption of power (i.e., a "double disconnect") and the internal battery is discharged or underpowered, there may not be an audible alarm. The internal battery is the final mitigation in a cascade of power management risk controls, which include labeling, patient training and alarms related to external battery charge. A failure of the internal controller battery has no impact on normal functionality of the controller and is unlikely to have a clinical impact, provided patients follow the Patient Manual and never disconnect from both power sources at the same time.
- Worn Alignment Guides – The alignment guides in the controller's power supply connector ports may wear down over time. The notice instructs patients to inspect their controller's power supply ports for potential wear or damage to the alignment guides or connection pins. If damage is found, patients should use care when connecting power sources to avoid twisting or bending the power connection pins, and should contact their healthcare provider to schedule an appointment and possibly arrange for a replacement controller. Over time, substantial wear-and-tear to power supply connectors could result in the inability to connect to a power source, potentially resulting in an interruption in electrical connectivity, which could lead to a pump stop. Pump stops could cause death or serious injury. During the past 18 months, HeartWare has been made aware of worn alignment guides in approximately 1% of distributed controllers. HeartWare has initiated a program to improve the strength of the alignment guides in the controller's power supply connector ports to reduce possible damage to the connection pins.
- Power Management Software Upgrades – In certain situations, it is possible that a temporary loss of communication between the controller and the batteries can result in premature "battery switching" or false battery alarms. Unnecessary battery switching and false battery alarms do not increase risk to patients, but may result in an increase in alarms or the need for more frequent battery changes. HeartWare is developing a software upgrade to improve how the controller manages a transient loss of communication between the controller and HVAD System batteries. The software upgrade is expected to become available later in 2015, at which time physicians will notify their patients. In the meantime, the notice reminds patients to always treat battery alarms in accordance with the instructions in the Patient Manual.
- Driveline Outer Sheath Discoloration and Cracking – Patients should be aware that the driveline outer sheath may become discolored or display small cracks over time. This outer, protective covering contains a plastic material that may degrade if exposed to excessive ultraviolet (UV) light, such as from direct sunlight or tanning beds, while the internal driveline conductors remain protected and intact. Discolored or cracked outer sheaths have not demonstrated an elevated safety risk, but could contribute to the risk of infection at the exit site. The notice reminds patients to keep their driveline protected under their clothing as described in the Patient Manual. HeartWare introduced a thicker sheath in 2013 internationally and 2014 in the U.S. that has generated fewer complaints related to discoloration and cracking than the thinner sheath.
- Driveline Pulling and Snagging – Patients should take care when managing their drivelines to avoid accidental snagging or pulling, which could cause damage to the driveline or a disconnection. If a driveline is severely damaged or disconnected from the controller, electrical issues or pump stops are possible, which could lead to serious injury or death. Patients are reminded to follow the instructions in the Patient Manual and not to pull, kink or twist their drivelines. For example, the notice reminds patients to avoid catching their driveline on hazards such as door knobs, seat belts or vehicle brake handles.
Patients who experience these issues should contact their physician or VAD Coordinator at their hospital center. Clinicians with questions should contact their HeartWare representative, call HeartWare's 24-hour Clinical Support line at (888) 494-6365 or email FSCA@heartware.com.
HeartWare has advised the U.S. Food and Drug Administration (FDA) of this action. Adverse reactions or quality problems experienced with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
About HeartWare International
HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat patients suffering from advanced heart failure. For additional information, visit the company's website at www.heartware.com.
Investor and media contact:
HeartWare International, Inc.
Phone: +1 508 739 0864
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/heartware-international-issues-voluntary-device-correction-300095854.html
SOURCE HeartWare International, Inc.