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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA AFMC BLOODLINES; FJK

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FRESENIUS MEDICAL CARE NORTH AMERICA AFMC BLOODLINES; FJK Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 04/17/2015
Event Type  Death  
Event Description
A user facility reported that a patient coded during hemodialysis treatment.The following is based on the medical records received by the patient's treatment facility.During a dialysis the patient reportedly stated she needed to sit up, she collapsed and lost consciousness.Cardiopulmonary resusitation (cpr) was initiated and ems was called.She did not have any viable signs of life and her rhythm appeared to be asystole with background pacemaker activity.Initial cardiac rhythm ems reported was pulseless electrical activity (pea) and noted that patient had a pacemaker.The patient was intubated, cpr was resumed and epinephrine, bicarbonate and narcan were administered.The patient was transported to the hosp where she was diagnosed with cardiac arrest, acute respiratory failure and cardiac dysrhythmia.Resuscitation continued with an external jugular line was sited and arterial blood gases drawn.The resuscitative efforts were stopped and the patient expired.Dialysis settings at clinic for (b)(6) 2015: dialysate composition 2.0k, 2.5ca, mg 1.0, 100 dextrose; sodium 137meq/l; bicarb machine setting 35meq/l, bfr 4.0, blood pressure prior to dialysis 94/66.
 
Manufacturer Narrative
This is being reported as part of a system level investigation which will include an investigation of all fresenius products potentially in use at the time of the event.Medical record review: medical records were received and reviewed by post market surveillance clinical staff.It was noted that patient had prior hospitalization on (b)(6) 2015 - generalized fatigue over a week, increased shortness of breath, edema, orthopnea and elevated irn as high as 13 at home (irn is 12.32, chest x-ray does show evidence of congestive heart failure with effusion) treated with iv diuretics.Suspected-chf, blood loss anemia, coagulopathy, elevated irn so coagulopathy is being reversed, urinary tract infection treated with antibiotics, acute kidney injury or chronic kidney disease, left lower extremity cellulitis treated with expanded antibiotics, profound hypothyroidism, elevated liver function tests could be a component of hepatic congestion from her congestive heart failure, history of breast cancer, unclear if it is in remission, no death certificate or autopsy results were received.A supplemental report will be submitted upon completion of the plant's investigation.
 
Manufacturer Narrative
Initial mdr recorded "irn" values however a transcription error was identified.The values are for international normalized ratio "inr".The system level review of the 2008k2 device and concomitant products found no indication that the products caused or contributed to the clinical event.
 
Event Description
The following is based on additional medical records received.The patient's primary cause of death was obtained from the end stage renal disease death notification form 2746.Primary cause of death was documented to be cardiac arrest, cause unk.There was no secondary cause recorded.Correction from initial mdr blood flow rate (bfr): 400; blood pressure prior to dialysis on (b)(6) 2015 was 10/03/1968.
 
Manufacturer Narrative
Device review: the device was not returned to the manufacturer for physical evaluation.The customer was unable to provide the manufacturer with the lot number of the bloodlines used in the reported event.As no lot number was provided by the complainant, a record review was performed on each of the lot numbers shipped to the complainant in the three months leading up to the reported event.The record review found 19 lot numbers shipped to the customer during that time period.The batch production records for these lots were reviewed.The batch records confirmed that released product met specifications, and documented manufacturing process controls were within specification.Per the documented product investigation, there was no indication that the fresenius bloodlines caused, contributed to or was a factor in the reported event.
 
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Brand Name
AFMC BLOODLINES
Type of Device
FJK
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
reynosa
MX 
Manufacturer (Section G)
ERIKA DE REYNOSA, S.A. DE C.V.
parque industrial reynosa
reynosa, tamaulipas 8878 0
MX   88780
Manufacturer Contact
tanya taft, rn cnor
920 winter st
waltham, MA 02451-1457
7816999000
MDR Report Key4787125
MDR Text Key20807547
Report Number8030665-2015-00254
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 Other,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? Yes
Initial Date Manufacturer Received 04/20/2015
Initial Date FDA Received05/20/2015
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 Initial
Patient Sequence Number1
Treatment
LORTAB 5/325,; OPTIFLUX DIALYZER,; PRAVASTIN,; BENADRYL,; VENOFER,; HYDRALAZINE,; LASIX,; MIRALAX,; POTASSIUM CHLORIDE,; WARFARIN.; GRANUFLO,; NATURALYTE,; ZOLOFT,; NEXIUM,; CARVEDILOL,; ASPIRIN,; AMIODARONE,; FRESENIUS SALINE,; CITRASATE,; FRESENIUS 2008K HEMODIALYSIS SYSTEM,
Patient Outcome(s) Death;
Patient Age53 YR
Patient Weight71
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