MAUDE Adverse Event Report: FRESENIUS MED CARE NORTH AMERICA FRESENIUS COMBISET 2008

Model Number FMC BLOODLINES

Device Problem Insufficient Information (3190)

Patient Problems Cardiopulmonary Arrest (1765); Ventricular Tachycardia (2132); Loss Of Pulse (2562); No Code Available (3191)

Event Date 09/17/2008

Event Type  Injury  

Event Description

The following is based on the medical records provided by the pt's attorney.The plaintiff's attorney alleged that the pt experienced a cardiovascular event on (b)(6) 2008 after the use of the product.On (b)(6) 2008: the attorney alleged via these medical records that the pt experienced cardiopulmonary arrest 3 hours into hemodialysis called sudden cardiac death or ventricular tachycardia.During the hemodialysis, the pt became unresponsive.An aed was placed and the pt was shocked back into normal sinus rhythm.The pt had ventricular tachycardia while en route.Multiple shocks were given.She did not have cpr or mechanical ventilation.She was bagged with spontaneous resolution of her pulseless state.On arrival in the er, she is awake, moaning, not really following commands, but she does have blood pressure of 130/60 with a pulse of 80's and 90's.Respiratory rate is 14.She was admitted to icu.The pt received implantable cardioconverter defibrillator as a treatment on (b)(6) 2008.She was also placed on amiodarone.The pt was discharged home in a stable condition on (b)(6) 2008.

Manufacturer Narrative

(b)(4).Medical records were received for a total of (b)(6) pages and reviewed by the post market clinical staff.We did not receive any treatment sheets or clinic logs for this event.Most recent co3 level was 29.7 on (b)(6) 2008 but not during the event or hospitalization from (b)(6) 2008.We also did not receive dialysis treatment sheets from (b)(6) 2008.The actual (b)(4) product was not returned to the manufacturer for eval and no product identifiers were provided.Manufacturing review is being performed by the manufacturing site.In addition, based on the pt's cardiac pulmonary arrest during use of hemodialysis as found in this particular medical records review, there will be an mdr filed for all fmc products mentioned as the devices and products that were reported to be in use at the time of pt's event.Based on the info received at this time it is indeterminate if fmc products caused or contributed to this event.A supplemental report will be submitted upon completion of the investigation.This is one event (cardiovascular) for the same pt involving six separate products; associated mdr # 1225714-2014-01087, 1225714-2014-01088, 1713747-2014-00154, 1713747-2014-99932, 8030665-2014-00256 and 2937457-2014-00504.

• Brand Name: FRESENIUS COMBISET 2008
• Manufacturer (Section D): FRESENIUS MED CARE NORTH AMERICA; reynosa, tampas CP 88 780; MX CP 88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st; waltham, MA 01451-1457 ; 7816999000
• MDR Report Key: 3733551
• MDR Text Key: 19922187
• Report Number: 8030665-2014-00256
• 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: 03/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FMC BLOODLINES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CONCENTRATES; NORMAL SALINE; BLOODLINE; DIALYSIS MACHINE; DIALYZER
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 68 YR
• Patient Weight: 78