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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; VENTRICULAR (ASSISST) BYPASS
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| Model Number 1420 |
| Device Problems
No Audible Alarm (1019); Display or Visual Feedback Problem (1184); Use of Device Problem (1670); Battery Problem (2885); Power Problem (3010)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 02/11/2022 |
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Event Type
malfunction
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Manufacturer Narrative
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Additional information has been requested regarding the patient's weight and the controller serial number in the event, 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.Additional products: brand name: heartware ventricular assist system ¿ battery / model #: 1650 / catalog #: 1650 / expiration date: 30-sep-2019 / serial or lot#: (b)(4) / udi #:(b)(4) / device available for evaluation: yes, return date: 01-mar-2022 / device evaluated by mfr: no, device evaluation anticipated, but not yet begun / dev rtn to mfr? yes / mfg date: 29-sep-2018 / labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿ battery / model #: 1650 / catalog #: 1650 / expiration date: 30-sep-2019 / serial or lot#: (b)(4) / udi #:(b)(4) / device available for evaluation: yes, return date: 01-mar-2022 / device evaluated by mfr: no, device evaluation anticipated, but not yet begun / dev rtn to mfr? yes / mfg date: 29-sep-2018 / labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿ battery / model #: 1650 / catalog #: 1650 / expiration date: 30-sep-2019 / serial or lot#: (b)(4) / udi #:(b)(4) / device available for evaluation: yes, return date: 01-mar-2022 / device evaluated by mfr: no, device evaluation anticipated, but not yet begun / dev rtn to mfr? yes / mfg date: 29-sep-2018 / labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿ battery / model #: 1650 / catalog #: 1650 / expiration date: 30-sep-2019 / serial or lot#: (b)(4) / udi #:(b)(4) / device available for evaluation: yes, return date: 01-mar-2022 / device evaluated by mfr: no, device evaluation anticipated, but not yet begun / dev rtn to mfr? yes / mfg date: 29-sep-2018 / labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿ battery / model #: 1650 / catalog #: 1650 / expiration date: 30-sep-2019 / serial or lot#: (b)(4) / udi #:(b)(4) / device available for evaluation: yes, return date: 01-mar-2022 / device evaluated by mfr: no, device evaluation anticipated, but not yet begun / dev rtn to mfr? yes / mfg date: 29-sep-2018 / labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿ battery / model #: 1650 / catalog #: 1650 / expiration date: 30-sep-2019 / serial or lot#: (b)(4) / udi #:(b)(4) / device available for evaluation: yes, return date: 01-mar-2022 / device evaluated by mfr: no, device evaluation anticipated, but not yet begun / dev rtn to mfr? yes / mfg date: 29-sep-2018 / labeled for single use: no (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient accidentally disconnected both power sources from the controller and the screen was black.It was also reported that the patient accidentally disconnected both power sources from the controller a second time which resulted in a black screen and a no power alarm occurred.It was further reported that the batteries exhibited power switching with multiple power disconnects and the patient heard a single beep when the power sources were not switching.The controller remains in use and the batteries were removed from service.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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A supplemental report is being submitted for additional information.Newly added a4 for patient weight.Investigation of this event is pending and a supplemental report will be sent upon its completion.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.
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Event Description
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It was further reported that the patient did not hear the no power alarm the first time that they accidentally disconnected the power sources.
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Manufacturer Narrative
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A supplemental report is being submitted for a correction to the event details and coding.Investigation of this event is pending and a supplemental report will be sent upon its completion.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.
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Manufacturer Narrative
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###a supplemental is being submitted for additional information and correction.Additional information: - h10 addt manufacturer for mdr: product event summary for the event.Corrected sections: - h10 addt manufacturer for mdr: correction for additional device battery (b)(6).The device was not returned.The device details such as ¿dev rtn to mfr?¿ corrected from ¿yes¿ to ¿no¿.And d9 corrected from ¿yes, return date: 01-mar-2022¿ to ¿no¿.Additional products: (b)(6) ¿ battery h3: yes h6: fda method code(s): b15, b01 h6: fda results code(s): c07 h6: fda conclusion code(s): d11 (b)(6) ¿ battery h3: yes h6: fda method code(s): b01, b15 h6: fda results code(s): c04, c07 h6: fda conclusion code(s): d01, d11 (b)(6) ¿ battery h3: yes h6: fda method code(s): b01, b15 h6: fda results code(s): c04, c07 h6: fda conclusion code(s): d01, d11 (b)(6) ¿ battery h3: yes h6: fda method code(s): b15, b01 h6: fda results code(s): c07 h6: fda conclusion code(s): d11 (b)(6) ¿ battery h3: yes h6: fda method code(s): b01, b15 h6: fda results code(s): c04, c07 h6: fda conclusion code(s): d01, d11 (b)(6) ¿ battery d9: no h3: yes dev rtn to mfr? no h6: fda method code(s): b15, b17 h6: fda results code(s): c04 h6: fda conclusion code(s): d01 product event summary: one (1) controller ((b)(6)) and one (1) battery ((b)(6)) were not returned for evaluation.Five (5) batteries ((b)(6)) were returned for evaluation.Various analyses were conducted and reviewed to evaluate the performance of the returned devices in relation to the reported event.Failure analysis of the returned batteries revealed that the devices passed functional testing.Visual inspection of the returned batteries revealed damage to the outer sheaths near the connector strain reliefs of the output cable assemblies, exposing the insulated internal wires; however, the observed damage did not affect the functionality of the devices.These are additional findings not related to the reported event.The most likely root cause of the observed damaged battery cables event can be attributed to wear on the strain reliefs and/or the handling of the devices.Capa (b)(4) is investigating damage to power sources.Log file analysis revealed that the controller contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Analysis of the data log file revealed several premature power switching events that were due to momentary disconnections involving (b)(6) and (b)(6).Review of the data log file also revealed several momentary disconnections that did not lead to premature power switching events involving (b)(6), (b)(6), (b)(6), and (b)(6).Momentary disconnection will result in an audible tone or "beep." log file analysis also revealed two (2) controller power up events with associated pump start events logged on 11-feb-2022 at 07:57:35 and (b)(6) 2022 at 17:07:39.The data point prior to the first loss of power revealed that (b)(6) was connected to power port one (1) with 45% relative state of charge (rsoc) and a power adapter was connected to power port two (2).The data point recorded after the first loss of power revealed that (b)(6) was conn ected to power port one (1) and (b)(6) was connected to power port two (2).The data point prior to the second loss of power revealed that (b)(6) was connected to power port one (1) with 25% rsoc and (b)(6) was connected to power port two (2) with 24% rsoc.The data point recorded after the second loss of power revealed that (b)(6) was connected to power port one (1) and (b)(6)was connected to power port two (2).No anomalies were observed leading up to the losses of power.The controller was without power for 8 and 10 seconds, respectively.A loss of power to the controller will result in a continuous audible alarm and the controller screen going blank.As a result, the reported losses of power, "blank screen", premature power switching, and beeps events were confirmed.The reported "no power alarm not sounding" event could not be confirmed.There is no evidence that the lubrication servicing had been performed on the associated power sources.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of the reported no sound event may be attributed to, but not limited to, a damaged speaker and/or a faulty internal component.The most likely root cause of the reported premature power switching event and ¿beeps" event can be attributed to momentary disconnections between the controller and batteries.Capa (b)(4) investigated momentary disconnections.Even though this capa is closed, the controller and batteries fall within the bounds of this capa.A possible root cause of the losses of power can be attributed to the reported disconnections of both power sources from the controller as described in the event details.Capa (b)(4) is investigating controller losses of power.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.
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