MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FMC BLOODLINES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

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

Patient Problem Death (1802)

Event Date 08/01/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).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.Manufacturing investigation: the device was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A manufacturing review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius bloodline products shipped to this account within the selected time frame.A records review was performed on the lots identified.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lots passed all release criteria.A review of the batch production records did not reveal a probable cause for the customer complaint.There were no non-conformances identified that relate to the reported event, and all lots met release criteria.Clinical investigation: the patient medical records were provided by the facility on august 15, 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.The esrd death notification (form 2746) documented the following event details: the date of death was noted as being (b)(6) 2016, the modality at the time of death was in-center hemodialysis, and the primary cause of death was listed as cardiac arrest with cause unknown.Renal replacement therapy was not discontinued, and the patient was not receiving hospice care prior to their death.There is no documentation in the medical record supporting a possible association between the fresenius dialysis products in-use during the patient¿s final hd treatment, the event of cardiopulmonary arrest, and the outcomes of hospitalization and death.However, there exists a likely association between the patient¿s co-morbid diseases of left ventricular heart failure, severe mitral regurgitation, severe left atrial enlargement, pulmonary hypertension, severe mitral valve prolapse, and the patient adverse event, and subsequent outcomes of hospitalization and death.

Event Description

A facility medwatch was received for a distributed product (non-fresenius manufactured) which detailed a patient adverse event.The event pertains to a (b)(6), female patient with past medical history of acute on chronic diastolic congestive heart failure, severe recurrent mitral regurgitation, and single leaflet detachment of mitraclip, atrial fibrillation and diabetes, who experienced cardiac arrest approximately 3 hours into the 3 hour 15 minute hemodialysis (hd) treatment.The patient presented to the user facility on (b)(6) 2016 for a routinely scheduled hemodialysis (hd) treatment.The following case details were provided.At 1:22 pm, 0.5 units of lidocaine hcl 1% was administered via intradermal route to the arteriovenous graft (avg).At 1:25 pm, a 500 unit heparin sodium bolus was administered via intravenous (iv) route.The hd treatment was initiated at 1:33 pm without issue.At 2:00 pm, 325mg acetaminophen was administered via oral route.At 2:33 pm, patient was alert with a complaint of nausea; the patient subsequently vomited.Ultrafiltration (uf) rate decreased from 1080ml/hr to 760ml/hr, and 200 ml of normal saline was administered via iv route.At 3:42 pm, a clot was visualized in venous chamber.The patient was reinfused, no blood loss occurred, the treatment was paused, and the hd machine was re-strung and primed with a new extracorporeal circuit.At 3:55 pm, the treatment was resumed, ultrafiltration rate increased to 1020ml/hr.At 4:46 pm, the patient was found unconscious.The patient was placed in trendelenburg position, and a code was called.Normal saline was administered (dose not reported), cpr was initiated, oxygen 8l/min via bag valve mask was administered, and an aed was applied.Shock advised, and then administered.Chest compressions resumed, aed analyzed rhythm, another shock was advised, the aed failed to deliver the second shock and presented the audible warning "change batteries." chest compressions continued until ems arrived and took over resuscitation efforts.The patient was then transported to the hospital via ambulance.During the transport to the hospital, the patient's heart rhythm was ventricular fibrillation.The patient was defibrillated, and a return of spontaneous circulation was achieved.The patient presented to the hospital's emergency department nonresponsive, with dilated, fixed pupils, no spontaneous breaths, gag reflex, or corneal reflex, or pupillary reflex noted.The patient, with brain death suspected, was intubated and transferred to the intensive care unit (icu).Once admitted to the icu, hypothermia protocol was initiated to rule out advanced cardiac life support (acls) medication toxicity.A ct scan was performed which showed no evidence of intracranial abnormality.Approximately two hours into the hypothermia protocol, the patient experienced asystole.Chest compressions were not administered per family request.The acls protocol was run with medications, however, all resuscitation efforts were terminated at the request of the family, and the patient subsequently passed away.The machine passed all pre-treatment testing and there were no machine malfunctions or unusual alarms during the treatment.Following the event, the machine was removed from service for evaluation.The user facility biomedical technician performed functional testing and no malfunctions were identified; no repairs or calibrations were required.The unit was returned to service at the user facility with no issues being reported.No malfunction of any fresenius device in use at the time of the event was alleged, observed, or identified, prior to, during, or following the patient's hd treatment.The 2008t hemodialysis (hd) machine is not available for evaluation.The dialyzer and bloodline are not available for evaluation by the manufacturer as both were discarded by the user facility.No samples of the acid/bicarb in use during the treatment are available for analysis.

• Brand Name: FMC BLOODLINES
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5939805
• MDR Text Key: 54334922
• Report Number: 8030665-2016-00473
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 73