MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 14 VOLT POWER MODULE PATIENT CABLE

Catalog Number 103426

Device Problems Device Stops Intermittently (1599); Device Dislodged or Dislocated (2923)

Patient Problems Memory Loss/Impairment (1958); No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2016

Event Type  Injury  

Manufacturer Narrative

The power module patient cable is a vendor product.Only the vendor lot number is imprinted on the device.The manufacturer¿s lot number and unique device identifier (udi) are provided on the outer packaging of the power module patient cable; they are not imprinted on the actual device.The packaging was discarded; therefore, the manufacturer¿s udi could not be determined.The vendor manufactures large batches of patient cables that are used across multiple left ventricular assist system kits.The device is expected to be returned for analysis.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad).It was reported that the patient fell at the nursing home while trying to ambulate to the bathroom by way of a wheelchair while connected to the power module and "somehow got disconnected from power." there was visible damage to the power module patient cable.The staff at the nursing home placed the patient on battery power and the lvad parameters were stable upon admission to the hospital.The patient was reportedly neurologically intact but had mild forgetfulness only surrounding that morning's events.No injuries were reported.Log files evaluated by the manufacturer's technical services representative showed a pump stoppage of unknown duration.The patient was stable on the hospital equipment.The patient's peripheral equipment was upgraded.The patient reportedly did well with the education of the new products and was discharged to the nursing home on (b)(6) 2016.

Manufacturer Narrative

The reported damage to the patient cable and pump stoppage was confirmed based on photos that were provided by the vad coordinator; however, a specific cause for the event and a correlation between the observed damage and pump stoppage could not be conclusively determined because the patient cable was not returned for evaluation.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 14 VOLT POWER MODULE PATIENT CABLE
• Type of Device: POWER MODULE PATIENT CABLE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 5478243
• MDR Text Key: 39629228
• Report Number: 2916596-2016-00381
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 103426
• Device Lot Number: 34756240210
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2016
• Initial Date FDA Received: 03/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 167