• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1103
Device Problems Failure to Pump (1502); Pumping Stopped (1503); Pumping Problem (3016)
Patient Problem Low Cardiac Output (2501)
Event Date 07/13/2022
Event Type  Death  
Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion. Additional products: heartware ventricular assist system ¿controller 2. 0 model #: 1420 / catalog #: 1420 / expiration date: 31-mar-2021 / serial #: (b)(4) udi #: (b)(4) , device evaluation anticipated, but not yet begun. Mfg date: 10-mar-2020 no h6: patient ime code(s): (b)(6) h6: imf code(s): f02, f08, f2303 h6: img code(s): g04035 h6: fda device code(s): a1203, a0708, a1108 h6: fda method code(s): b21 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 d1: heartware ventricular assist system ¿battery d4: model #: 1650 / catalog #: 1650 / expiration date: 30-apr-2022 / serial #: (b)(4) udi #: (b)(4) d9: device evaluation anticipated, but not yet begun h4: mfg date: 26-apr-2021 h5: no h6: patient ime code(s): (b)(4) h6: imf code(s): (b)(4) h6: img code(s): (b)(4) h6: fda device code(s): (b)(4) h6: additional products: heartware ventricular assist system ¿cac adapter d4: model #: unk / catalog #: unk / expiration date: unk / serial #: unk udi #: unk d9: device evaluation anticipated, but not yet begun h4: mfg date: unk h5: no h6: patient ime code(s): (b)(4) h6: imf code(s): (b)(4) h6: img code(s): (b)(4) h6: d1: heartware ventricular assist system ¿ controller 2. 0 d4: model #: 1420 / catalog #: 1420 / expiration date: 31-jan-2023 / serial #: (b)(4) udi #: (b)(4) d9: device evaluation anticipated, but not yet begun h4: mfg date: 24-jan-2022 h5: no h6: patient ime code(s): (b)(4) h6: imf code(s): (b)(4) h6: img code(s): (b)(4) additional information has been requested regarding event details, but it was not available at the time of this report. If additional information is received, the event will be updated and a supplemental report will be sent. 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.
 
Event Description
It was reported that the patient was at a rehabilitation center and the staff heard an alarm from the ventricular assist device (vad). The staff entered and saw ¿vad stop change controller,¿ but could not find the patient¿s backup controller. The patient was transported to the hospital where a controller exchange was attempted without success. It was noted that the patient had a double power disconnect and the vad failed to restart despite several attempts. Log file review noted low flow alarms and unexpected power loss on the controller. It was noted that a battery and controller ac adapter were connected to the controller prior to the controller power up. It was also noted that the controller time was off by one hour, where the controller read 10:05 but real time was 11:05. The patient was placed on inotropes. As the patient was do-not-resuscitate (dnr)/do-not-intubate (dni), it was decided to not attempt any further controller exchanges to avoid a possible stroke. The patient remained on inotropes and care was withdrawn. It was noted that the vad was off, so the patient had low cardiac output. The patient subsequently died.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Type of DeviceVENTRICULAR (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 Key15066182
MDR Text Key296240528
Report Number3007042319-2022-06648
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/20/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/20/2022 Patient Sequence Number: 1
Treatment
5076-52 LEAD, 5076-45 LEAD, W1DR01 IPG
-
-