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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA COMBISET TRUE FLOW; BLOODLINE
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FRESENIUS MEDICAL CARE NORTH AMERICA COMBISET TRUE FLOW; BLOODLINE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Diarrhea (1811); Fever (1858); Sepsis (2067); Chills (2191); Heart Failure (2206); No Code Available (3191)
Event Date 11/16/2014
Event Type  Death  
Manufacturer Narrative
Cough, body-aches, transplanted kidney complications.Additional info has been requested and will be submitted upon receipt.P medical records received from the plaintiff's attorney for the initially reported event (sepsis with death outcome) were review and revealed the complaint as a system-level with on-set of the event occurring late fall ((b)(6) 2013) with sequela through the pt's demise on (b)(6) 2014.However, in spite of this, event occurring on (b)(6) 2014, tachycardia during dialysis treatment in clinic on a different machine) was captured as a second system-level complaint set (although it appears this is a morbid condition following/occurring as a consequence of the initial event).Both system-level complaint sets are being referred to one another with these regulatory reports.This is one of two events associated with one pt captured as two system level complaint sets under the following mfr report numbers: event one (event date: (b)(6) 2013) mfg report numbers: 1713747-2015-999398, 1713747-2015-00490, 1225714-2015-07561, 1225714-2015-07472, 8030665-2015-00500, 1225714-2015-07470 and 1225714-2015-07471.Event two (event date: (b)(6) 2014) mfg report numbers: 1713747-2015-999398, 713747-2015-00491, 8030665-2015-00501, 2937457-2015-01564, 1225714-2015-08023, and 1225714-2015-08024.
 
Event Description
The plaintiff's attorney alleged the pt expired from heart failure secondary to sepsis and reported the pt was diagnosed with sepsis late winter, spring.Additional info, medical records provided by the plaintiff's attorney noted the pt became ill during home dialysis treatment, which ended 28 minutes early against medical advice (pt discontinued treatment to go to bathroom).The pt was noted to have diarrhea.Afterwards, the pt presented to the hospital experiencing cough, fever, chills, and body ache and was admitted.Approximately nine days later the pt was transferred to a different hospital due to continued elevated temperature and to obtain specialized care.The pt was ultimately treated and, discharged to home on antibiotics with a diagnosis of transplanted kidney complication and local infection d/t central venous catheter.Further info noted the endocarditis was ruled out and source of infection was not indicated.
 
Manufacturer Narrative
This is one of two events associated with one patient captured as two system level complaint sets under the following mfg.Report numbers: event 1 (date (b)(6) 2013) mfg report numbers: 1713747-2015-999398, 1713747-2015-00491, 12257141-2015-07561, 1225714-2015-07472, 8030665-2015-00501, 1225714-2015-08024 and 1225714-2015-07471.Event 2 (date: (b)(6) 2014).Mfg.Report numbers: 1713747-2015-999398, 713747-2015-00490, 80306665-2015-00500, 2937457-2015-01564, 1225714-2015-08023, and 1225714-2015-08024.
 
Event Description
Additional information noted: post failed kidney transplant, the patient was on home hemodialysis (hd) starting in early (b)(6).In late (b)(6), the patient went to the e.R.With intermittent fever of up to 105f.Patient also had body aches, weakness and decreased appetite with nausea and vomiting.The patient was diagnosed with unspecified fever, treated with iv rocephin and released with antibiotics.Approximately 1 month later, the patient discontinued dialysis treatment 20 to 28 minutes early (against medical advice) to use the bathroom.The patient had diarrhea and was noted to have a low-grade fever for about three weeks.Patient presented to the e.R.With fever, chills, body aches and productive cough with yellow sputum.Patient was admitted and treated for enterococcus sepsis, but continued to have fever and respiratory symptoms.The patient's dialysis catheter was replaced.Four days post admission, patient was transferred to transplant center.Patient had an immature av fistula.Work-up for source of fever was unrevealing; patient was discharged about 22 days later, afebrile and stable.Next day, the patient arrived in clinic for dialysis but did not receive dialysis due to tachycardia.Patient went to the hospital w/tachycardia an was diagnosed with pancreatitis and acute cholecystitis.Next day, patient was admitted to the transplant hospital where dialysis and iv antibiotics were started.Sepsis secondary to pancreatitis and a thickened gallbladder with stones were confirmed.Patient was discharged 5 ays later with antibiotics.Five days post discharge, the patient experienced tachycardia during dialysis treatment, heart rate exceeded 200 with a 7.5 potassium level.Dialysis was stopped and patient was sent to the er.Cholecystitis and pancreatitis were diagnosed.Iv antibiotics and calcium gluconate were administered.Patient was taken to transplant hospital where a cholecystectomy was done.Patient was discharged 11 days later with jackson pratt drains.In clinic dialysis treatment continued, and 37 days post last discharge, patient was sent to er from the physicians office w/left flank pain.Lab work was done and patient was admitted with tactic acid elevation, fever and leukocytosis.Patient was transferred to the transplant hospital for evaluation.Upon arrival patient was confused; the admitting diagnosis was sepsis with shock and altered mental status.Patient was treated w/antibiotics and antifungals and found to have developed cardiomyopathy and hypotension w/decrease in ejection fraction.Eighteen days later, patient was discharged to long-term care center for rehab an continued treatment for cardiac issues.Eleven days post rehabilitation center admission, patient was discharged with a life vest.The patient again began clinic dialysis.Approximately 1 month later, the patient presented to the clinic for dialysis and was sent tot he e.R.For elevated heart rate.Iv lopressor was administered; this decompensated the patient's condition, causing the patient to go into pulseless electrical activity (pea).Cpr was performed; a low blood pressure and pulse were obtained.Patient was kept in icu overnight and transferred to transplant hospital next day.Four days later the patient went into pea, coded and expired.Cause of death on death certificate noted: biventricular heart failure secondary to sepsis.
 
Manufacturer Narrative
Additional info was requested regarding time frame for exposure to the alleged contaminated lot number.Medical records don't reveal if the pt was exposed to recalled product, the lot number or name of the concentrate used during dialysis.Medical records do not allege a recalled or contaminated product resulted in sepsis.Before (b)(6) 2013 the pt was receiving home hemodialysis of the 2008k machine.Following discharge from the hospital (b)(6) 2015 the pt began clinic hemodialysis on the 2008t machine.A 160nre dialyzer was used for home and clinic therapy.Medical records do not indicate specific concentrates used for home or clinic dialysis.Medical records reveal the cause of sepsis was not determined.There were two hospitalizations for sepsis ((b)(6) 2013) without resolution and no etiology.The pt was diagnosed with cholecystitis (b)(6) 2014 with a cholecystectomy (b)(6) 2014.Pt also had non-gallbladder related sepsis on (b)(6) 2014 with no etiology.Medical records don't indicate causal relationship between the fresenius products and sepsis.Medical records report the pt developed sepsis after starting hemodialysis in (b)(6) 2013.Medical records report a past medical history of rejecting the kidney causing the use of corticosteroids, cellcept decrease immunity and mask inflammatory symptoms and introduction of dialysis into a compromised physiological state where human element exists could reasonably contribute to sepsis.No cause for infectious process was determined (except (b)(6) 2014).There's no document the sepsis of (b)(6) 2013 resolved evidenced by frequent hospitalizations in a short time.Pulseless electrical activity occurred after receiving lopressor and the compromised cardiac status would contribute to pts eventual pea and death.Additional info from the clinical investigation (ci) has been reported.This last follow-up report to provide the ci.This is one of two events associated with one pt captured as two system level complaints sets: event 1 (date (b)(6) 2013) mfg.Report numbers: 1713747-2015-999398, 1713747-2015-00491, 1225714-2015-07561, 1225714-2015-07472, 8030665-2015-00501, 1225714-2015-07470 and 1225714-2015-07471.Event 2 (date: (b)(6) 2014) mfg.Report numbers: 1713747-2015-999398, 713747-2015-00490, 8030665-2015-00500, 2937457-2015-01564, 1225714-2015-08023, and 1225714-2015-08024.
 
Manufacturer Narrative
Additional info from the clinical investigation was received and is being reported accordingly.Follow-up reports will be sent consecutively daily to provide all info.Therefore, this is one of multiple follow-up reports being submitted to provide the clinical investigation info.At the time of the last follow-up report for the clinical investigation, a note will be provided indicating such.This is one of two events associated with one patient captured as two system level complaint sets under the following mfg.Report numbers: event 1 (date (b)(6) 2013) mfg.Report numbers: 1713747-2015-999398, 1713747-2015-00491, 1225714-2015-07561, 1225714-2015-07472, 8030665-2015-00501, 1225714-2015-07470 and 1225714-2015-07471.Event 2 (date: (b)(6) 2014) mfg.Report numbers: 1713747-2015-999398, 713747-2015-00490, 8030665-2015-00500, 2937457-2015-01564, 1225714-2015-08023, and 1225714-2015-08024.
 
Manufacturer Narrative
From the system level review of the 2008k@home device and concomitant products, it appears there is no indication that these products caused or contributed to the clinical event.This is one of two events associated with one patient captured as two system level complaint sets under the following mfg.Report numbers: event 1 (date (b)(6) 2013) mfg.Report numbers: 1713747-2015-999398, 1713747-2015-00491, 1225714-2015-07561, 1225714-2015-07472, 8030665-2015-00501, 1225714-2015-07470 and 1225714-2015-07471.Event 2 (date: (b)(6) 2014) mfg.Report numbers: 1713747-2015-999398, 713747-2015-00490, 8030665-2015-00500, 2937457-2015-01564, 1225714-2015-08023, and 1225714-2015-08024.Upon receipt of additional info, a supplemental report will be submitted.
 
Manufacturer Narrative
Additional info from the clinical investigation (ci) is being reported.Follow-up reports will be sent daily to provide all info.A note will be provided at the time of the last ci follow-up report.This is one of two pt events captured as two system level complaint sets under the following mfg.Report numbers: event 1 (date (b)(6) 2013) mfg.Report numbers: 1713747-2015-999398, 1713747-2015-00491, 1225714-2015-07561, 1225714-2015-07472, 8030665-2015-00501, 1225714-2015-07470 and 1225714-2015-07471.Event 2 (date: (b)(6) 2014) mfg.Report numbers: 1713747-2015-999398, 713747-2015-00490, 8030665-2015-00500, 2937457-2015-01564, 1225714-2015-08023, and 1225714-2015-08024.
 
Manufacturer Narrative
Additional info from the clinical investigation was received and is being reported accordingly.Follow-up reports will be sent daily to provide all info.This is the second of multiple follow-up reports being submitted to provide clinical investigation info.At the time of the last follow-up report for the clinical investigation, a note will be provided.This is one of two events associated with one patient captured as two system level complaint sets under the following mfg.Report numbers: event 1 (date (b)(6) 2013) mfg.Report numbers: 1713747-2015-999398, 1713747-2015-00491, 1225714-2015-07561, 1225714-2015-07472, 8030665-2015-00501, 1225714-2015-07470 and 1225714-2015-07471.Event 2 (date: (b)(6) 2014) mfg.Report numbers: 1713747-2015-999398, 713747-2015-00490, 8030665-2015-00500, 2937457-2015-01564, 1225714-2015-08023, and 1225714-2015-08024.
 
Manufacturer Narrative
The device was not returned to the manufacture for physical evaluation.Therefore a sales search was performed, to verify the product activity; unfortunately the entire lot has been sold and distributed.A retrospective device history record review did not identify any non-conformance reports or other abnormalities during the assembly of related lots were found.Based on this, is concluded the product involved met current specifications.This is one of two events associated with one patient captured as two system level complaint sets under the following mfg.Report numbers: event 1 (date (b)(6) 2013) mfg.Report numbers: 1713747-2015-999398, 1713747-2015-00491, 1225714-2015-07561, 1225714-2015-07472, 8030665-2015-00501, 1225714-2015-07470 and 1225714-2015-07471.Event 2 (date: (b)(6) 2014) mfg.Report numbers: 1713747-2015-999398, 713747-2015-00490, 8030665-2015-00500, 2937457-2015-01564, 1225714-2015-08023, and 1225714-2015-08024.
 
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Brand Name
COMBISET TRUE FLOW
Type of Device
BLOODLINE
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
waltham MA
Manufacturer (Section G)
ERIKA DE REYNOSA, S.A. DE C.V.
parque industrial reynosa
reynosa, tamaulipas CP 88 780
MX   CP 88780
Manufacturer Contact
corie vazquez
920 winter street
waltham, MA 02451
MDR Report Key5204010
MDR Text Key30577403
Report Number8030665-2015-00501
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 10/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/06/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Death; Life Threatening;
Patient Weight70
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