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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK

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SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK Back to Search Results
Catalog Number 293001-001
Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/28/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4), 2 of 4.
 
Event Description
The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under four separate medical device reports: companion external li-battery pack s/n (b)(4) (mfr report # 3003761017-2015-00279, companion external li-battery pack s/n (b)(4) (mfr report # 3003761017-2015-00281), and companion external li-battery pack s/n (b)(4) (mfr report # 3003761017-2015-00282).The customer reported that the companion external batteries in an unplugged companion 2 driver were losing charge quicker than what was displayed on the battery gauge.The customer also reported that all four external batteries were tried on the same driver with the same result.The customer also reported that the patient subsequently switched to the backup companion external batteries without any adverse patient impact.This alleged failure mode poses a low risk to the patient since the low battery did not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver has a redundant, alternate power source of external wall power.The companion external batteries will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
 
Manufacturer Narrative
(b)(4).Fup 1 - 2 of 4.
 
Event Description
The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under four separate medical device reports: companion external li-battery pack s/n (b)(4) (mfr report # 3003761017-2015-00279, companion external li-battery pack s/n (b)(4) (mfr report # 3003761017-2015-00280), companion external li-battery pack s/n (b)(4) (mfr report # 3003761017-2015-00281), and companion external li-battery pack s/n (b)(4) (mfr report # 3003761017-2015-00282).The customer reported that the companion external batteries in an unplugged companion 2 driver were losing charge quicker than what was displayed on the battery gauge.The customer also reported that all four external batteries were tried on the same driver with the same result.The customer also reported that the patient subsequently switched to the backup companion external batteries without any adverse patient impact.Companion external battery s/n (b)(4) was returned to syncardia for evaluation.Visual inspection of the external battery revealed no abnormalities.The external battery was connected to battery evaluation software, and review of the data revealed that the external battery was functional, and no permanent faults were logged.In addition, the state of charge values were consistent with the gas gauge displayed values.The external battery was functionally tested and passed all test requirements.In addition, the external battery met the minimum required discharge duration of 30 minutes.The customer-reported issue could not be reproduced during testing, and there was no evidence of a device malfunction.The companion 2 driver system operator manual (c2-900005), at chapter 13, "power management," advises users that when fully charged, each companion external battery provides a minimum of 30 minutes of support.Two fully charged external batteries provide a minimum of 60 minutes of support.External battery support may vary based on driver settings.After disconnecting from wall power, the companion 2 driver display will take approximately one minute to update the estimated battery support time based on driver settings.The reported issue posed a low risk to the patient because it did not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver has redundant, alternate power sources of external wall power and an internal, emergency battery.In addition, all power sources are continually monitored by the companion 2 driver, with audible and visual alarms provided to annunciate any potential issues with the driver power sources.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.
 
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Brand Name
SYNCARDIA COMPANION EXTERNAL LI-BATTERY PACK
Type of Device
BATTERY PACK
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5056942
MDR Text Key25840246
Report Number3003761017-2015-00280
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 08/31/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number293001-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/31/2015
Initial Date FDA Received09/04/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age30 YR
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