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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UCSD HOSPITAL THERAKOS UVAR XT; PHOTOPHERESIS SYSTEM

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UCSD HOSPITAL THERAKOS UVAR XT; PHOTOPHERESIS SYSTEM Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Death (1802); Death (1802); Hemorrhage/Bleeding (1888); Renal Failure (2041); Renal Failure (2041); Thrombosis (2100); Misdiagnosis (2159); Misdiagnosis (2159); Fungal Infection (2419)
Event Date 06/06/2014
Event Type  Death  
Event Description
My (b)(6) daughter, (b)(6) died, while trying to recover, from a perfect 10/10 sibling hla donor match.But her doctor wasn't, it seems, very experienced at his job, as he liked to let on.She was only having the bone marrow transplant, as an alternative treatment, as to cure sickle cell, to have the rest of her next 40 to 50 yrs, free from sickle cell pain.Not to shorten her life at (b)(6), broke our heart! instead of this being alternative treatment to cure, dr.(b)(6), treated as an 'knock-down experiment' with his misdiagnosed, no treatment too, and over medication with high doses; cyclosporine 125mg, while also on, rapamune, and tacrolimus, all at same time! which caused kidney injury, and liver was damaged.She died renal failure.But that's not all.Dr.(b)(6) could control her blood pressure for over a full year, in fact towards the end, of 329 days, in his care, he had put her on 5 different blockers/medication, at same time, as well and that didn't help at all, but there's more! she had every infectious disease, like in a third world country, no treatment.Only steroids, and toxic medication, such as; alemtuzumab/campath, valcyte, prednisone, etc., she had sepsis twice.He also, made her klebsiella infection resistant to any treatment, in protection, by administration of; smx/tmp 800-160mg, which made it worst for her.She suffered and i had to watch, yet knowing, that this was all wrong! so finally, i said something.Spoke up, told the staff i want to bring someone else in to treat my daughter, and said she hasn't gotten better in over a whole year.We need a second opinion is what i said to dr.(b)(6), on that day.But instead, he talks us into trying this machine to cleanse her blood: photopheresis procedure, without ever, once ordering biopsy to exclude / to treatment.She died disseminated aspergillus and renal failure.
 
Event Description
Additional information received from report on 08/22/2016 on report mw5057348: the machine used: therakos uvax xt 125 small bowl/rij tunneled catheter/anticoagulation used: heparin 10,000 units in 500 ml ns.The problem is that the patient was given a d-dimer hla pre-test, which was 80 - high positive risk tt/p, for a clinical event to patient.Lupus coagulation was told to use, but instead, this doctor used: heparin 10,000 units the whole time of hospital stay was: 322 days! at the time of death, patient had clinical event: cardiovascular system was completely destroyed.Extensive thrombosis in lft and rt jugular, aorta, superior vena cava and all four major branches burst, duct seen closed, bleed out, (b)(6) 2014.Hospital acquired bp 171/101 at times.Even while she slept.Fumigatus misdiagnosed to gvhd, instead she really had disseminated aspergillus fumigatus after being exposed to from her home while on visit family after a bmt transplantation with her sibling brother.Family had no idea or disclosure told about a very bad mold problem directly below home in crawl space.No vaccines, and over use of steroids.
 
Event Description
My (b)(6) daughter, (b)(6) died, while trying to recover, from a perfect 10/10 sibling hla donor match.But her doctor wasn't, it seems, very experienced at his job, as he liked to let on.She was only having the bone marrow transplant, as an alternative treatment, as to cure sickle cell, to have the rest of her next 40 to 50 yrs, free from sickle cell pain.Not to shorten her life at (b)(6), broke our heart! instead of this being alternative treatment to cure, dr.(b)(6), treated as an 'knock-down experiment' with his misdiagnosed, no treatment too, and over medication with high doses; cyclosporine 125mg, while also on, rapamune, and tacrolimus, all at same time! which caused kidney injury, and liver was damaged.She died renal failure.But that's not all.Dr.(b)(6) could control her blood pressure for over a full year, in fact towards the end, of 329 days, in his care, he had put her on 5 different blockers/medication, at same time, as well and that didn't help at all, but there's more! she had every infectious disease, like in a third world country, no treatment.Only steroids, and toxic medication, such as; alemtuzumab/campath, valcyte, prednisone, etc., she had sepsis twice.He also, made her klebsiella infection resistant to any treatment, in protection, by administration of; smx/tmp 800-160mg, which made it worst for her.She suffered and i had to watch, yet knowing, that this was all wrong! so finally, i said something.Spoke up, told the staff i want to bring someone else in to treat my daughter, and said she hasn't gotten better in over a whole year.We need a second opinion is what i said to dr.(b)(6), on that day.But instead, he talks us into trying this machine to cleanse her blood: photopheresis procedure, without ever, once ordering biopsy to exclude / to treatment.She died disseminated aspergillus and renal failure.
 
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Brand Name
THERAKOS UVAR XT
Type of Device
PHOTOPHERESIS SYSTEM
Manufacturer (Section D)
UCSD HOSPITAL
la jolla
MDR Report Key5184723
MDR Text Key29748447
Report NumberMW5057348
Device Sequence Number2
Product Code LNR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 10/25/2015
2 Devices were Involved in the Event: 1   2  
2 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/06/2015
Other Device ID NumberT36 4P109BP136/7402
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/25/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/18/2016
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Death;
Patient Age18 YR
Patient Weight62
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