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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMISET TRUE FLOW; BLOODLINE (FJK)
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ERIKA DE REYNOSA, S.A. DE C.V. COMISET TRUE FLOW; BLOODLINE (FJK) Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Tachycardia (2095); No Code Available (3191)
Event Date 01/20/2014
Event Type  Injury  
Manufacturer Narrative
Additional information has been requested and will be submitted upon receipt accordingly.Note: medical records received from the plaintiff's attorney for the initially reported event (sepsis with death outcome) were reviewed and revealed the complaint as a system-level with on-set of the event occurring late fall ((b)(6) 2013) with sequela through the patient's demise on (b)(6), 2014.However in spite of this, the event occurring on (b)(6), 2014, (tachycardia during dialysis treatment in clinic on a different machin) 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 within these regulatory reports.This is one of two event associated with one patient captured as two system level complaint sets under the following mfg.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 1228714-2015-07471.Event two (event date: january 20, 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
Medical records provided by the plaintiff's attorney noted the patient experienced episodes of tachycardia and elevated potassium level at 7.5 during outpatient hemodialysis treatment.Consequently, the patient was sent to the emergency department where the tachycardia was confirmed.The patient was treated for tachycardia and hyperkalemia.Next day, the patient was transferred to the transplant hospital for specialized care where diagnoses of acute cholecystitis, pancreatitis and hyperkalemia were made.The patient was administered intravenous antibiotics and calcium gluconate, and a cholecystectomy was completed.Pancreatitis was slow to improve.The patient was discharged to home 12 days post hospital admission with pancreatis and on antibiotics.
 
Manufacturer Narrative
Add'l info was requested regarding the 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 on 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 tow 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 documentation 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 pt's eventual pea and death.Add'l info from the clinical investigation (ci) has been reported.This last f/u report to provide the ci.This is one of two events associated with one pt captured as two system level complaint sets: event ((b)(6) 2013) mfg no.: 1713747-2015-999398, 1713747-2015-00491, 1225714-2015-07561, 1225714-2015-07472, 8030665-2015-00501, 1225714-2015-07470, 1225714-2015-07471.Event 2 ((b)(6) 2014)mfg no.: 1713747-2015-999398, 1713747-2015-00490, 8030665-2015-0050, 2937457-2015-01564, 1225714-2015-08023, 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
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
The system level review of the 2008t machine and concomitant products found that the serial number of the durable equipment and lot numbers of the concomitant products used during the event to be unknown and unavailable for evaluation.As evaluation of complaint, retain, or companion samples could not be performed, there is no info available to conclude that the products caused or contributed to the event.This is one of two events associated with one pt captured as two system level complaint sets: event 1 (11/16/3013) mfg no.: 1713747-2015-999398, 1713747-2015-00491, 1225714-2015-07561, 1225714-2015-07472, 8030665-2015-00501, 1225714-2015-07470, 1225714-2015-07471 event 2 (01/20/2014) mfg no.: 1713747-2015-999398, 1713747-2015-00490, 8030665-2015-00500, 2937457-2015-01564, 1225714-2015-08023, 1225714-2015-08024.Upon receipt of add'l info, a supplemental report will be submitted.
 
Manufacturer Narrative
The device was not returned to the mfr for physical evaluation and product identifiers were not provided.A retrospective device history record review to a specific product or lot number was not performed as product identifiers are unknown.A sales search was conducted to identify production lots sold to the customer three months prior to the alleged complaint event; however, no records for this time period were found.A definitive conclusion regarding the involvement of the product could not be determined without physical examination of a complaint sample.This is one of two events associated with one pt captured as two system level complaint sets under the following mfg report numbers: event 1 (date (b)(6) 3013) mfg report nos.: 1713747-2015-999398, 1713747-2015-00491, 1225714-2015-07561, 1225714-2015-07472, 8030665-2015-00501, 1225714-2015-07470, 1225714-2015-07471 event two 2 (event date: (b)(6) 2014) mfg report nos.: 1713747-2015-999398, 1713747-2015-00491, 8030665-2015-00501, 2937457-2015-01564, 1225714-2015-08023, 1225714-2015-08024.Upon receipt of add'l info, a supplemental report will be submitted.
 
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
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.
 
Event Description
Additional information noted: post failed kidney transplant, the patient was on home hemodialysis (hd) starting in early fall.In late fall, the patient to the er with intermittent fever of up to 105f.Patient also had body aches, weakness and decreased appetite with nausea/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 er with fever, chills, 4 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 with tachycardia and 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 stones were confirmed.Patient was discharged 5 days 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 physician's office with left flank pain.Lab work was done and patient was admitted with lactic 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 with antibiotics, and antifungals and found to have developed cardiomyopathy and hypotension with decrease in ejection fraction.Eighteen days later, patient was discharged to long-term care center for rehab and 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 to the er 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 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.
 
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Brand Name
COMISET TRUE FLOW
Type of Device
BLOODLINE (FJK)
Manufacturer (Section D)
ERIKA DE REYNOSA, S.A. DE C.V.
reynosa
MX 
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
7816999071
MDR Report Key5203998
MDR Text Key30594216
Report Number8030665-2015-00500
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) Hospitalization; Life Threatening; Required Intervention;
Patient Age32 YR
Patient Weight70
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