HeartWare

Ventricular Assist Systems

HeartWare System Urgent Field Safety Notice-April 2015

Recall

Driveline Cable Splice Assembly

4 Pages

May 08, 2015 URGENT FIELD SAFETY NOTIFICATION ® HeartWare Driveline Cable Splice Assembly Identifier: Type of Action: Product Codes: Range of Serial #s: FSCA APR2015B Safety Notification ASY00116, ASY00281 All Patients with Driveline splice repair Dear HeartWare Clinician, This is the second of two (2 of 2) Safety Notifications that you are receiving related to retraction of connector pins; however, this notification is specific to a subset of patients that have undergone splice repair of the HVAD Driveline... ur records indicate that you have one or more patients that have ® These patients are identified in the undergone a splice repair of their HVAD Driveline... cknowledgement and Completion Form on page 3 of this notification... s part of HeartWare’s ongoing product performance monitoring, we have received a limited number of complaints relating to the retraction of connector pins within the driveline splice assembly following a splice repair... e believe that the retraction of the splice assembly connector pins may be the result of excessive force applied to the driveline from accidental dropping of Controllers or snagging of drivelines on items such as door handles or other hazards... etween April 2010 and March 2015, 35 patients underwent a splice repair... etraction of the splice assembly connector pins occurred 15 times, likely due to the application of excessive force to the driveline... f these failures, 2 may have contributed to a patient death... eartWare is finalizing enhancements designed to increase the strength of the splice assembly to avoid the retraction of splice assembly connector pins... eartWare will notify clinicians when an improved repair kit is available... e are targeting to release the repair kit within the next few months... isk: Accidental pulling or snagging of the driveline may result in excessive force being placed on the splice assembly... his can result in the retraction of the splice assembly connector pins and may lead to electrical faults or pump stops... ump stops can result in death or serious injury... Damaged to Splice Assembly Connector Pins Total Complaints No Serious Adverse Event Serious Adverse Event Death 15 12 1 2 Actions to be taken by the Patient: Patients should take care when managing their driveline to avoid accidental dropping of Controllers or snagging of drivelines, which could result in excessive force being placed on the splice repair... or example, patients should avoid having an exposed loop in the driveline that could catch on hazards such as door knobs, seat belts or brake handles... atients should not pull, kink or twist the driveline... f a patient should inadvertently damage his or her driveline or splice assembly, the patient should NOT attempt to repair the driveline as it may lead to inadvertent injuries, but should contact his or her clinician IMMEDIATELY for instructions and to schedule an appointment for a new splice repair by a HeartWare technician... 4400 NW 60th Avenue, Miami Lakes, FL 33014 USA File: FSCA APR2015B... T 305... 4... 01 F 305... 4... 65 www... artware... m Page 1 of 2 Actions to be taken by the Clinician HeartWare requests that you complete the following actions: 1... eview this notice and the attached “Patient Communication” and familiarize yourself with its contents... orward this notice to those individuals within your organization who need to be aware of this notice... erify the list of patients in the “Acknowledgement and Completion Form,” showing your patients who have undergone a splice repair according to HeartWare records... istribute the “Patient Communication” to your affected patients in person, via FedEx or some other reliable means of communication... lease contact your HeartWare representative should you need any assistance with this process or to schedule a splice repair by a HeartWare technician... ontinue to reinforce the messages set forth in this notice with your patients who have experienced a splice repair during their regularly scheduled appointments... omplete, sign and return the “Acknowledgement and Completion Form” to HeartWare within 30 days of receipt of this letter... his notice needs to be passed on all those who need to be aware with your organization or to any organization where the potentially affected devices have been transferred... lease transfer this notice to other organizations on which this action has an impact... lease maintain awareness on this notice and resulting action to ensure effectiveness of the corrective action... hould you have any questions or concerns, please contact your local HeartWare representative... ur 24Hour Clinical Support personnel are also available at +49 511 676936911 (Germany) or +44 7534 245492 (UK)... eartWare may also be reached via the European Authorized Representative, MedPass International Ltd... on +44 (0) 1452 619 222 (telephone and fax) and MedPass... @medpass... g (email)... eartWare is distributing this voluntary safety notice with the knowledge of the Regulatory Agencies consistent with applicable regulations... incerely, Vice President, Quality & Design Assurance Attachments: 1... cknowledgement and Completion Form 2... atient Communication 14400 NW 60th Avenue, Miami Lakes, FL 33014 USA File: FSCA APR2015B... T 305... 4... 01 F 305... 4... 65 www... artware... m Page 2 of 2
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File Name: heartware_system_urgent_field_safety_notice_-drivel.pdf
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