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U.S. Department of Health and Human Services


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Model Number 106531US
Device Problems No Audible Alarm (1019); Disconnection (1171); No Display/Image (1183); Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2022
Event Type  malfunction  
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event Description
It was reported that the patient was having multiple falls over the last couple of weeks and mean arterial pressure (map) after the fall was reading between 62-64. No alarms were noted and log files were sent for review. The event log displayed 118 pulsatility index (pi) events occurring (b)(6) 2022 13:24 pm - (b)(6) 2022 12:18 pm. All pi events will cause the heartmate 3 ventricular assist device (vad) speed to drop to its low speed limit, which was set at 5400 rpm. It was noted that although common bodily functions such as sneezing and coughing have been known to trigger a pi event, the pi events that were seen were of a significant amount and may possibly point to another issue. Other possible causes for these pi events could be a hypovolemic state, set speed was set to high, rv failure, arrhythmia, bradycardia or inadequate hr, bleeding, tamponade and map too high or low. There were no other unusual events seen within the log files. The mcs equipment was operating as expected and did not appear to have contributed tp the reported "patient had several falls in the last couple of weeks. " on (b)(6) 2022 the patient had an event when pulling into the hospital parking lot. Low flow alarms were sounding and the patient became unresponsive and regained consciousness within about one minute. The patient was awake and admitted to the cardiac intensive care unit with abnormal laboratory values including a low hemoglobin and hematocrit and a mean arterial pressure of 62 for which intravenous fluid bolus was given. The times were off related to the time change and not being resynched but the log file was submitted for review. The event log contained persistent of pi events all throughout the log along with low flow alarms with high pi on (b)(6) 2022 from 10:15 to 10:26am. The pi events were considered routine. Most of the low flow events were not sustained (less than 10 seconds to trigger the alarms). The estimated flow was fluctuating below 2. 5 lpm threshold and seemed to be physiological in nature. The vad was functioning as intended. On (b)(6) 2022 it was reported that the patient's system controller had no lights or sounds displayed during it's daily check. The vad coordinator disconnected the white power cord and the system controller alarmed and displayed the correct symbol. There were no other issues with the system controller. On (b)(6) 2022 the event occurred again and on that event, it took several minutes got the system controller to respond. It was reported that with both episodes the patient was awakened and had been laying on the system controller. The system controller felt hot at the time of both episodes. The log files were sent for review. On (b)(6) 2022, the event log capture persistent pi events. The log file did not capture any controller fault alarms and did capture the power cable disconnect mentioned on (b)(6) 2022 by the vad coordinator. It was recommended that if they felt that this issue was being caused by external hardware to swap out the system controller as possible causes to alleviate the issue when it was clinically safe for the patient. There were no other notable alarm conditions or parameter changes. The vad was functioning as intended. A controller change was performed without any issue. A warranty replacement was requested. The controller was to be returned for analysis.
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Manufacturer (Section D)
6035 stoneridge drive
pleasanton CA 94588
Manufacturer (Section G)
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
MDR Report Key14104819
MDR Text Key289285142
Report Number2916596-2022-10354
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number106531US
Device Catalogue Number106531US
Device Lot Number7536279
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial