MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE ICU COVER (1-PACK); VENTRICULAR (ASSISST) BYPASS

Model Number	10003491
Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the pocket controller was delivered and there was water damage.The pocket controller and icu cover were returned.Related manufacturer report number of controller: 2916596-2021-04293.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a water damaged outer carton box was confirmed during analysis.Visual inspection of the carton box for heartmate icu cover revealed the box was intact.There was no impact to the icu cover or documents (ifu) inside the box.The device history records were reviewed and the records revealed the heartmate icu cover was manufactured in accordance with mfg and qa specifications.The heartmate 3 instructions for use in section "symbols" (under ¿description of labeling symbols¿), includes a description of the general symbol which indicates to not use if package is damaged.This symbol is present on the label on the heartmate 3 system controller carton (10014616-a/10014615-a).Heartmate iii instructions for use section entitled ¿equipment storage and care¿ addresses how to properly care for, maintain, and store equipment for proper use.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE ICU COVER (1-PACK)
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12252187
• Report Number: 2916596-2021-04292
• Device Sequence Number: 3670391
• Product Code: DSQ
• UDI-Device Identifier: 00813024013488
• UDI-Public: 00813024013488
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 10003491
• Device Catalogue Number: 10003491
• Device Lot Number: 7982018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1