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

Catalog Number 293001-001

Device Problems Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2014

Event Type  malfunction  

Event Description

The reported issue involves the syncardia companion 2 driver and two companion external batteries and are reported under three separate medical device reports: companion 2 driver s/n (b)(4) (mfr report #3003761017-201-00283); companion external battery s/n (b)(4) (mfr report # 3003761017-2014-00286); and companion external battery s/n (b)(4).The customer reported that the companion 2 driver displayed an "emergency battery low" alarm and all battery indicator lights were red while supporting a patient.The customer also reported that the companion 2 driver "emergency battery low" alarm resolved within seconds and all companion external battery lights were green.

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because it did not prevent the companion 2 from performing its life-sustaining functions.The companion 2 drier and companion batteries will be returned to syncardia for evaluation.The results of the investigation will be provided in supplemental mdrs.

Manufacturer Narrative

(b)(4).

Event Description

The reported issue involves the syncardia companion 2 driver and two companion external batteries and are reported under three separate medical device reports: (1) companion 2 driver s/n (b)(4) (mfr report # 3003761017-2014-00283); (2) companion external battery s/n (b)(4) (mfr report # 3003761017-2014-00286); and (3) companion external battery s/n (b)(4) (mfr report # 3003761017-2014-00287).The customer reported that the companion 2 driver displayed an "emergency battery low" alarm and all battery indicator lights were red while supporting a patient.The customer also reported that the companion 2 driver "emergency battery low" alarm resolved within seconds and all companion external battery lights were green.Companion external battery s/n (b)(4) was returned as a precautionary measure, to determine if it could have contributed to the root cause of the "emergency battery low" alarm reported in companion 2 driver s/n (b)(4) (mfr report # 3003761017-2014-00283).An investigation was conducted and the root cause of the customer reported alarm was a malfunction of the power management piston cylinder assembly (pca) on the companion 2 driver.Review of the incoming inspection record for the external battery revealed no anomalies.The battery met all manufacturing procedures and incoming inspection criteria prior to being placed in finished goods.A visual and mechanical inspection of the battery was performed and no physical anomalies were found.The battery was tested in accordance with (b)(4), companion external battery evaluation procedure, and passed all final performance testing.The battery performed as intended, and there was no evidence of a malfunction.The investigation confirmed that the battery was not the root cause of the customer reported "emergency battery low" alarm as described in mfr report # 3003761017-2014-00283.The battery met all inspection and testing acceptance criteria and will be returned to service.

• 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 (Section G): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; ce 2491; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4352378
• MDR Text Key: 21773013
• Report Number: 3003761017-2014-00287
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2014

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: Other Health Care Professional
• Device Catalogue Number: 293001-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 12/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 51 YR