MAUDE Adverse Event Report: THORATEC CORPORATION HMII, G2.3, POCKET CONTROLLER

Model Number	10005080
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when attempting to connect the system controller to the power module, the black power cable could not make connection.Upon closer inspection, the nurse noted a broken pin that was stuck in the cable.The patient required a controller exchange.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of broken pin stuck inside the black connector of the system controller was confirmed.The returned system controller was found to have a stuck pin in position 5 of the black power cable which is unused in that cable.The pin was removed to continue with testing.The controller was functionally tested and found to operate as intended during analysis.The controller was able to support pump function for an extended period of time.No atypical alarms were produced during testing.The ifu states in the ¿guideline for power cable connectors¿ section to line up the half circles inside the connectors and gently bring the connectors together, turning them slightly to make the connection.A root cause for the reported event cannot be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.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.Heartmate ii instructions for use section 7-¿alarms and troubleshooting¿ and heartmate ii patient handbook section 5-¿alarms and troubleshooting¿ explain the guidelines for power cable connectors.Heartmate ii instructions for use section 8-¿equipment storage and care¿ and heartmate ii patient handbook section 6-¿caring for the equipment¿ explain how to properly take care and maintain the integrity of the system controller.The ifu states in the ¿guideline for power cable connectors¿ section to ¿line up the half circles inside the connectors¿ gently bring the connectors together, turning them slightly to make the connection, if needed¿ never twist connectors or pull them apart at an angle.¿ no further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HMII, G2.3, POCKET CONTROLLER
• Common Device Name: HMII, G2.3, POCKET CONTROLLER
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15513852
• Report Number: 2916596-2022-13820
• Device Sequence Number: 5856601
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: 00813024013013
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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 Expiration Date: 12/18/2024
• Device Model Number: 10005080
• Device Catalogue Number: 10005080
• Device Lot Number: 8240990
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 63 KG