MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FRESENIUS COMBISET BLOODLINES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Hypoxia (1918); Ventricular Fibrillation (2130); Loss Of Pulse (2562)

Event Date 04/26/2008

Event Type  Death  

Event Description

Medical records received from plaintiff's attorney reveal that during dialysis treatment, the pt was found not breathing and in cardiac arrest in the final two (2) minutes of dialysis.Cardiopulmonary resuscitation (cpr) was initiated and the automated external defibrillator was applied with no shock indicated, so cpr resumed.Emergency (911) was called.Blood was returned.Emergency medical technicians (emt) arrived and assumed responsibility for cpr.Emt applied oxygen, intubated pt, administered intravenous epinephrine, atropine and bicarbonate and converted pt into ventricular tachycardia and ventricular fibrillation.At hospital, cpr and advanced cardiac life support (acls) protocol was initiated.Pt received epinephrine, atropine, lidocaine and bicarbonate.Defibrillation was required when pt developed ventricular fibrillation and pulseless electrical activity (pea).Pt was resuscitated, admitted, diagnosed with cardiac arrest, ventricular fibrillation, pulseless electrical activity, and hypoxia.Blood pressure stabilized and continuous renal replacement therapy was initiated for aggressive ultrafiltration.Pt was maintained on three times a week intermittent hemodialysis.Pt continued on antibiotics to exclude infection concerns prior to necessary biventricular automatic implantable cardioverter defibrillator (aicd) placement for a currently malfunctioning aicd.Pt stabilized and was discharged to a long term care facility.

Manufacturer Narrative

Original info from the attorney alleged the pt subsequently expired from this event.Medical records confirm the pt experienced cardiac arrest during hemodialysis, was successfully resuscitated and discharged from hospital.Death records reveal pt expired six years later from the time of this event.This event was not related to the pt's death.Medical records do not indicate any causal relationship between the pt's dialysis and her death.There is no documentation in the medical that indicates pt was receiving dialysis at the time of her death.Medical records were requested for the events surrounding the pt's death.Medical records do not contain dialysis treatment records from this event for review.In addition, medical records do not contain progress notes, lab/diagnostic reports (other than those reported in this form), dialysis treatment sheets, medication records or physician orders from the hospitalization ((b)(6) 2008) for review.Serum bicarbonate levels are not available for review.There is no documentation in the medical record that indicates any causal relationship between the pt's hemodialysis and concomitant products and the cardiac arrest.Medical records reveal that this pt had a documented history of medical non-compliance.In addition, the pt has history of cardiac issues including a pacemaker placement, valve repair and valve replacements.Medical records reveal the pacemaker was malfunctioning and the cause of death as complication of renal disease.Based on the info at hand, it appears pt factors, and complex medical history with non-compliance may have contributed to the event.This is one of six device reports associated with this event.This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of the event.Further eval of the system level investigation has not yet been completed.A follow up report will be filed upon conclusion of the investigation.

Manufacturer Narrative

The system level review of the 2008k device and concomitant products found no indication that the products caused or contributed in any way to the clinical event.Upon receipt of additional information, a supplemental report will be submitted.

Manufacturer Narrative

A review of the device history record revealed no nonconformance reports or other abnormalities during the assembly of these lots were found.The product involved met current specifications.Complaint sample is not available for evaluation to confirm the alleged product malfunction.Therefore the complaint is deemed as not confirmed.This is one of six device reports associated with this event: 2937457-2015-01282, 8030665-2015-00332, 1713747-2015-00343, 1713747-2015-999221, 1225714-2014-13508, 1225714-2014-13509.Upon receipt of additional information, a supplemental report will be submitted.

• Brand Name: FRESENIUS COMBISET BLOODLINES
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; cd, reynosa, tamps ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynos; cd, reynosa, tamps 8878 0; MX 88780
• Manufacturer Contact: corie vazquez ; 920 winter street; waltham, MA 02451 ; 7816999071
• MDR Report Key: 4938095
• MDR Text Key: 6434995
• Report Number: 8030665-2015-00332
• 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,Consumer,Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• 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 Received: 07/08/2015
• 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 Number: 1
• Treatment: 208K; SALINE; CARVEDIDOL; VICODIN; GRANUFLO; CARAFATE; LISINOPRIL; COUMADIN; FMC BLOODLINES; DIALYZERS; REGLAN; RENALPLEX; NATURALYTE
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 66