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Model Number 106524US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adult Respiratory Distress Syndrome (1696); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pneumonia (2011); Septic Shock (2068); Thrombosis/Thrombus (4440)
Event Date 09/23/2021
Event Type  Injury  
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 admitted on (b)(6) 2021 for major bleeding and was given a blood transfusion.The patient's hemoglobin dropped to 6.7 g/dl and was up to 8.3 g/dl.On (b)(6) 2021 lab test, hypernatremia was found.The renal team was consulted, and continued with 40mg twice a day lasix and adjusted dextrose 5% in water.On (b)(6) 2021 the patient developed a major infection and had fever (38.4c and diarrhea).The patient failed to thrive and was returned to the intensive care unit (icu).Lab cultures showed no growth and was started on vancomycin and cefepime.On (b)(6) 2021 the patient developed anemia and their hemoglobin dropped to 6.6 g/dl and another transfusion of 1 unit packed red blood cells was given.The patient was in acute respiratory distress syndrome (ards) with showing signs of sepsis and septic shock, possible secondary to hospital acquired pneumonia in the setting of hypernatremia.The lvad was at 6000 rpm.Milrinone was continued at 0.125, stress dose steroids, and continued meropenem.They were on ventilatory support, status/post bronchoscopy twice with diffuse bleeding and friable tissue.The patient also developed a major infection but cultures negative of growth to date ¿ potentially bacterial pneumonia but pending any positive cultures.On (b)(6) 2021 the patient underwent a bronchoscopy with minimal secretions in their airway.On (b)(6) 2021 the patient was intubated for respiratory failure.On (b)(6) 2021 the patient was reintubated for ards and was treated with percutaneous tracheostomy and bronchoalveolar lavage.There was also some blood oozing from the tracheostomy packing.Hemoglobin and hematocrit stable.The patient was afebrile.
Manufacturer Narrative
Manufacturer's investigation conclusion: a direct correlation between the reported bleeding, infection, and peripheral thromboembolism and heartmate 3 left ventricular assist system (hm3 lvas), serial number (b)(6) could not be conclusively established through this evaluation and a specific cause for the reported events could not be conclusively determined.The patient remains ongoing with heartmate 3 left ventricular assist system, serial number (b)(6).The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.Heartmate 3 left ventricular assist system (hm3 lvas) instructions for use (ifu) is currently available and in section 1, (¿introduction¿) lists potential adverse events that may be associated with the use of the hm3 lvas, including infection, bleeding, and respiratory failure.Care instructions regarding preventing infection are provided in section 6, (¿patient care and management¿), as well as (under "anticoagulation") outlines the recommended anticoagulation regimen (including inr range) and lists thromboembolism as a potential late postimplant complication for patients using the heartmate 3 lvas.Section 6 also provides information regarding anticoagulation, including recommended international normalized ratio (inr) values.The heartmate 3 lvas patient handbook is also currently available.Care instructions for preventing infection are outlined in various sections of this document.No further information was provided.The manufacturer is closing the file on this event.
Event Description
The patient was given 1 unit prbc on (b)(6) 2021.On (b)(6) 2021 the patient experienced nonocclusive dvt (deep vein thrombosis) in the right common femoral vein found while with a subtherapeutic inr (international normalized ratio).On (b)(6) 2021 the tracheostomy was downsized to shiley #6, and on (b)(6) 2021 was downsized to shiley #4.On (b)(6) 2021 the shiley was capped on 4l o2 nc.On (b)(6) 2021 the patient's tracheostomy tube was decannulated.The patient completed their antibiotic course with no causative organism isolated, and is now off of antibiotics.The patient received 1 unit of prbc (packed red blood cells) on (b)(6) 2021.Patient had ongoing hematuria and clotting in foley catheter.The patient received 1 unit prbc on (b)(6) 2021 and another unit on (b)(6) 2021.The patient received 1 unit of prbc on (b)(6) 2021 and another unit on (b)(6) 2021.On (b)(6) 2021 the patient's chronic clotting required continuous bladder irrigation was status post a cystoscopy, clot evacuation, and fulguration of the bladder.The patient received 1 unit prbc on (b)(6) 2021 prior to the cystoscopy and 1 unit on (b)(6) 2021 post cystoscopy.The foley catheter was removed on (b)(6) 2021 and there have been no further episodes of hematuria.The patient's infection resolved status post taking meropenem ((b)(6) 2021) and vancomycin ( (b)(6) 2021), and status/post cefepime and vancomycin ( (b)(6) 2021).
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Brand Name
Type of Device
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 Key12674387
MDR Text Key277710725
Report Number2916596-2021-05805
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024013297
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 Study,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/15/2023
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number8088430
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Hospitalization; Required Intervention;
Patient Age73 YR
Patient SexMale
Patient Weight98 KG