MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE; VENTRICULAR (ASSISST) BYPASS

Device Problems Pumping Stopped (1503); Use of Device Problem (1670); Connection Problem (2900)

Patient Problems Confusion/ Disorientation (2553); Syncope/Fainting (4411); Heart Failure/Congestive Heart Failure (4446); Hyponatremia (4494)

Event Date 05/08/2013

Event Type  Injury  

Manufacturer Narrative

Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific de vice information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: importance of linguistic details in alarm messages of ventricular assist devices.International journal of artificial organs, june 2013; 36(6):406-9.Doi: 10.5301/ijao.5000205.Ep ub 2013 may 8.Pmid: 23653298 other devices involved in this event: brand name: heartware ventricular assist system ¿ controller 2.0 / controller / serial #: unk / model #: unk / expiration date: unk udi #: unk.Device available for evaluation: no.Mfg date: unk.Labeled for single use: no.(b)(4).Additional information was requested of the primary author regarding the cause of the event, device serial number and the patient¿s demographic data, but the author was unable to provide further details.If additional information is received, the event will be updated, and a supplemental report will be sent.Investigation of this event is pending, and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed which contained information regarding ventricular assist devices (vads).The article discussed recommended improvements to the display texts and foreign language translations used on the vad controller screen to make solving life-threatening issues easier to handle.It illustrated the need for such improvements using a case report from austria.One patient's post-operative course was complicated by the development of right heart failure and hyponatremia, necessitating hospitalization.During the hospital admission, in a state of altered mental status, the patient accidentally disconnected the driveline cable from the pump.The patient became unconscious while in bed, with the driveline cable falling underneath the bed covers.Hospital staff responded immediately to the pump stop alarm but were unable to reconnect the cable for ten minutes.The hospital staff was questioned the next day as to why it took so long to resolve the emergency.It was determined that the german-language translations used for the ¿pump stopped¿ and ¿driveline disconnected¿ alarm text were confusing to native german speakers.The hospital staff misinterpreted the text to mean the pump stop was an automatic planned feature of the pump and could not understand the need to reconnect the driveline, which was concealed under the bed covers.They initially connected the pump to the monitor, believing that was what the alarm instructed them to do.After the driveline cable was reconnected, the pump restarted, and the patient was transferred to the intensive care unit (icu) for three days.The patient survived with no permanent injury from the event.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for investigation completion.Product event summary: one pump and one controller with unknown serial numbers were not returned for evaluation.Log file analysis could not be performed since log files covering the reported event date were not available for analysis.As a result, the reported event could not be confirmed due to insufficient evidence.Of note, the pump will stop if the driveline is disconnected from the controller.Based on the available information, the devices may have caused or contributed to the reported event.The most likely root cause of the reported vad disconnect/ stopped alarms can be attributed to a physical disconnection of the driveline from the controller by the patient as described in the event details.Based on the available information, the reported "alarm texts were confusing" event may be attributed to user perception.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Other devices involved in this event: d1: heartware ventricular assist system ¿ controller 2.0 d4: controller / serial #: unk / model #: unk / expiration date: unk h6: fda method code: 4114 h6: fda results code: 3221 h6: fda conclusion code: 22 investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 14459220
• MDR Text Key: 292199865
• Report Number: 3007042319-2022-05171
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 58 YR
• Patient Sex: Male