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

Catalog Number 03-2722-9

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

Patient Problem Death (1802)

Event Date 03/21/2015

Event Type  Death  

Event Description

The pt presented at the hospital on (b)(6) 2015 with chest pain and headache.He stated he developed a headache earlier that day during his dialysis treatment.His chest pain developed on the left side and radiated to his left arm, neck and jaw.He also experienced orthopnea, blurry vision and lightheadedness.His vital signs: bp 237/117, heart rate 110, oxygen saturation 77% on room air and 90% on oxygen at 4 liters/min.The pt was given intravenous anti-hypertensive medications.The pt was diagnosed with hypertensive urgency and admitted to the hospital.On (b)(6) 2015, the pt stopped his hemodialysis treatment.He had been fidgety during the dialysis treatment and blood flows were lowered.On (b)(6) 2015, the pt started hemodialysis at 08:14.His vital signs were temp.97.9, pulse 88, respirations 16, bp 186/100.During his dialysis treatment, he had received zofran, norco and phenergan.At 11:00, this pt became non-responsive during his hemodialysis treatment.His heart rate was in the 40s and he was placed on bipap, narcan was administered with no improvement.Ekg showed peaked t-waves.Pulse was later lost and pt went into ventricular fibrillation.Code blue was called and cpr was initiated approx at 11:19.Pt was defibrillated 4 times.Time of death was called at 11:49.

Manufacturer Narrative

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.Medical record review: medical records were received and reviewed by post market surveillance clinical staff.It was noted that the medical records did not contain a death certificate or autopsy report for review.Bicarbonate blood labs are not reported in the medical records for review.There is no documentation in the medical record that shows as causal relationship between the pt's hemodialysis treatment and the pt's death.A supplemental report will be submitted upon completion of plant's investigation.

Manufacturer Narrative

Updated medical record review: based on the information provided, it is unknown how the device may have caused or contributed to the event.The post market surveillance department has reviewed the medical records provided.The patient is a (b)(6) male, with (end stage renal disease) esrd on hemodialysis therapy.The patient has hemodialysis therapy on (b)(6) 2015.The patient became "fidgety" and requested the treatment be terminated early.On (b)(6) 2015, the patient had hemodialysis therapy where he was administered pain and anti-nausea medication for complaints of pain.Approximately 2 hours and 45 minutes into treatment, the patient became non-responsive.Attempts at resuscitation were unsuccessful and the patient expired.The patient has a documented history of medical non-compliance and this was listed as a secondary cause of death.There is no documentation in the medical record that shows a causal relationship between the patient's hemodialysis treatment and the patient's death.Device review: the device was not returned to the manufacturer for physical evaluation.The lot number was provided via medical records.No product is available from this lot at distribution centers to be analyzed.The entire lot has been sold and distributed.The batch production records for this lot was 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 customer combi set caused, contributed to or was a factor in the reported event.The complaint sample is not available for evaluation to confirm the alleged product malfunction, therefore, the complaint is deemed as not confirmed.The system level review of the 2008k machine and concomitant products found no indication that the products caused or contributed in any way to the patient event.

Event Description

The following is based on additional medical information provided by the patient's nurse.On (b)(6) 2015 the patient's hemodialysis treatment orders were as follows: dialyzer f160, duration 4.5 hours, blood flow rate: as tolerated, dialysis flow rate: 800, dialysate k2, ca 2.5, bicarb 32, na 137.The patient's chronic out-patient dialysis facility provided the esrd death notification 2746 in lieu of the death certificate.The record was received and the primary cause of death was listed as cardiac arrest, cause unknown.Secondary causes were listed as cardiomyopathy and other-chronic medical noncompliance.

• Brand Name: FRESENIUS COMBISET 2008
• 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 CP 88 780; MX CP 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4764517
• MDR Text Key: 15247071
• Report Number: 8030665-2015-00236
• 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,Health Professional,User Facility,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/08/2015

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
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 15AR01194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 05/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA 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: SENSIPAR; NATURALYTE; HYRALAZINE; CLONIDINE; TOPROL; OPTIFLUX 160NRE
• Patient Outcome(s): Death; Hospitalization; Life Threatening
• Patient Age: 40 YR
• Patient Weight: 100