MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008; NONE

Device Problem Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Cardiopulmonary Arrest (1765); Encephalopathy (1833); Myocardial Infarction (1969)

Event Date 01/11/2010

Event Type  Injury  

Event Description

The following is based on the medical records provided by the patient's attorney.The plaintiff's attorney alleged the decedent experienced a cardiovascular event on (b)(6) 2009, another cardiovascular event on (b)(6) 2010 and subsequently expired on (b)(6) 2010 after the use of the product.On december 16, 2009, the patient experienced a questionable code at dialysis.There was a possibility that she was severely hypoglycemic at the time.Her troponins and cardiac enzymes were negative.She does get hypoglycemic right around lunchtime, especially because she did take her insulin and was unable to eat due to the timing of her treatment.When she got to the hospital she was feeling fine.She denied any complaint of chest pain or any other problem.She was discharged in 48 hours.On (b)(6) 2010, she experienced a cardiac arrest and coded at the outpatient hd unit and expired 4 days later.At the dialysis center the hd staff stated they lost her blood pressure and she stopped breathing.They initiated cpr.They released her to the paramedics to bring her over to the er.She coded in the er once.Since her code in the er she was on iv pressors and had no neurological response whatsoever since getting to the icu.An eeg showed diffuse hypoxic encephalopathy.For a period of time she was in status epilepticus but eeg did not show any seizure activity.Shortly after extubation, she lost all spontaneous respirations and passed away.

Manufacturer Narrative

This is one event (cardiovascular) of three events reported for the same patient involving six separate products.A systems level investigation is being performed to include all concomitant fmc products being used at the same time of the event.Medical records have been provided by the patient's attorney for an event reported via litigation.Additional files were opened based on a review of the medical records.This is an esrd patient, with multiple comorbidities: morbid obesity, diabetes, coronary artery disease, congestive heart failure, hypertension, and uncontrolled diabetes mellitus who experienced a questionable code at dialysis on (b)(6) 2009.There was a possibility that she was severely hypoglycemic at the time.Her troponins and cardiac enzymes were negative she was discharged in 48 hours.On (b)(6) 2010, she experienced a cardiac arrest at the outpatient hd unit and expired 4 days later.No death certificate/and or autopsy report were available for review.No facility clinic logs were received.The device was not returned to the manufacturer for physical evaluation.Based on the information received at this time it is indeterminate if the product caused or contributed to this event.This review will be updated when additional information is received.Complaint cannot be confirmed based on current information.Currently it is unknown if the device may have caused or contributed to the reported event.There is no history of specific malfunction or product being out of specifications, upon completion of the plant investigation, a supplemental report will be submitted.Related mdrs: 8030665-2014-00250, 2937457-2014-00451, 1713747-2014-00151, 1713747-2014-99930, 1225714-2014-01061 and 1225714-2014-01062.

• Brand Name: FRESENIUS COMBISET 2008
• Type of Device: NONE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st; waltham, MA 02451-1427 ; 7816999000
• MDR Report Key: 3710313
• MDR Text Key: 4246863
• Report Number: 8030665-2014-00250
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• 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 Received: 02/24/2014
• 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 Number: 1
• Treatment: NATURALYTE; GRANUFLO; COMBI SET; FMC 2008K; DIALYZER; SALINE
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 75 YR
• Patient Weight: 124