MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FMC BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

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

Patient Problems Cardiac Arrest (1762); Death (1802); Seizures (2063)

Event Date 10/03/2017

Event Type  Death  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A biomedical engineer (biomed tech) reported an adverse event occurred during hemodialysis treatment on (b)(6) 2017.Additional follow-up revealed a patient expired while dialyzing.Per biomed tech the machine did not have any issues during set-up and that the machine did not alarm at the time the patient expired.Kim stated no machine repairs were needed and the machine was placed back in service.The biomed tech stated the facility also used fresenius 2008t hemodialysis machines, fresenius dialyzers, bloodlines, acid concentrate delivered via jugs.Additional follow-up was made with the clinic manager, who revealed the patient expired when he was near the end of hemodialysis treatment at the beginning of the rinse back process.The clinic manager declined to have a fresenius res come out for machine evaluation.The clinic manager stated the patient¿s cause of death was cardiac arrest, and indicated the patient had pre-existing cardiac related issues as well as metastatic cancer.The clinic manager stated the patient was hospitalized the week prior due to cardiac related issues, and indicated the patient began his first hemodialysis treatment while hospitalized on (b)(6)2017, and received additional hemodialysis treatments on (b)(6) 2017 and (b)(6) 2017.The manager stated the patient was discharged (date unable to be provided) and was admitted to and had his first treatment at the clinic on (b)(6) 2017 and subsequently expired.Medical records were requested.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.The entire lot has been sold and distributed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A biomedical engineer (biomed tech) reported an adverse event occurred during hemodialysis treatment on (b)(6) 2017.Additional follow-up revealed a patient expired while dialyzing.Per biomed tech the machine did not have any issues during set-up and that the machine did not alarm at the time the patient expired.Kim stated no machine repairs were needed and the machine was placed back in service.The biomed tech stated the facility also used fresenius 2008t hemodialysis machines, fresenius dialyzers, bloodlines, acid concentrate delivered via jugs.Additional follow-up was made with the clinic manager, who revealed the patient expired when he was near the end of hemodialysis treatment at the beginning of the rinse back process.The clinic manager declined to have a fresenius res come out for machine evaluation.The clinic manager stated the patient¿s cause of death was cardiac arrest, and indicated the patient had pre-existing cardiac related issues as well as metastatic cancer.The clinic manager stated the patient was hospitalized the week prior due to cardiac related issues, and indicated the patient began his first hemodialysis treatment while hospitalized on (b)(6) 2017, and received additional hemodialysis treatments on (b)(6) 2017.The manager stated the patient was discharged (date unable to be provided) and was admitted to and had his first treatment at the clinic on (b)(6) 2017 and subsequently expired.Medical records were requested.

Manufacturer Narrative

Conclusion: a temporal association exists between the hd treatment using fresenius products (on (b)(6) 2017) and the pt¿s reported seizure event with subsequent cardiac arrest that ultimately resulted in pt.Death however, there is no documentation in the complaint file that supports a causal relationship.Additionally, there have been no reported allegations of a fresenius product malfunction causally associated with the patient¿s cardiac arrest and subsequent death.The patient¿s death was attributed to non-st elevation myocardial infarction (stemi).Cardiovascular disease complications are a leading cause of mortality among esrd patients maintained on hemodialysis.Sudden cardiac arrest associated with death is not uncommon among esrd patients maintained on dialysis.This patient had multiple pre-existing cardiovascular comorbidities (history of acute myocardial infarction, acute congestive heart failure, atrial arrhythmia, cardiomyopathy, coronary artery disease and hypertension).All these variables are significant risk factors and possible confounder for the sudden fatal cardiac arrest.Moreover, the possibility exists that pt¿s cardiac status may have been compromised prior to hd treatment (on (b)(6) 2017) as evidenced by an irregular heart rate prior to the start of hd treatment, patient complaints of chest pain relieved with two nitroglycerin on (b)(6) 2017, and reports of patient experiencing nausea, heartburn and loss of appetite.

Event Description

Information in the complaint file and received medical records were reviewed by a post market surveillance clinician.The patient was initiated on hemodialysis (hd) treatment after he was admitted to hospital for acute congestive heart failure associated with significantly impaired residual kidney function to warrant hemodialysis.The patient received first hd session through a left internal jugular catheter on (b)(6) 2017 and continued in-patient hd while hospitalized.The patient was subsequently discharged from the hospital on (b)(6) 2017 and recommended in center thrice weekly chronic hd to be carried out as an outpatient.On (b)(6) 2017 the patient received first scheduled in center hd treatment, as an outpatient, for a period of three and half hours.The patient presented to the out-patient hd clinic on (b)(6) 2017 with stable vital signs, note was made of irregular pulse with increased heart rate of 107/min.Patients pre-weight was recorded as (b)(6), with presence of pitting peripheral edema and decreased breath sounds.The patient complained of nausea (when brushing his teeth) and heartburn with loss of appetite and chest pains during evening hours on (b)(6) 2017 (prior to hd treatment) on two occasions which were relieved by nitroglycerine.Scheduled hd session was commenced at 11:41 hours with a blood flow of 400 milliliters per minute (ml/min) and dialysate flow of 600 ml/ min.The patient¿s ultrafiltration rate (ufr) was initiated at 480 (ml/hour) with weight target removal of 1.70 kilogram (kg).The patient was administered heparin as anticoagulant therapy.Routine blood samples were drawn prior to initiating hd session.Approximately two hours after start of treatment, the laboratory results revealed pre-dialysis serum k of 3.5 meq/l and the md at the clinic facility ordered a change in the dialysate bath to a 4 k, 2.25 ca composition.Hemodialysis treatment was ended at 14:08 and the patient¿s vital signs were; bp 100/80 mmhg and p 90 beats per minute.During the rinse back procedure at the end of this patient¿s first outpatient hemodialysis treatment, the patient felt dizzy and experienced an episode of seizure with no pulse detected and subsequently sustained cardiac arrest.Emergency medical services (ems) was notified while cardiopulmonary resuscitation (cpr) was initiated in the outpatient hd clinic and was transported to the hospital.The patient was defibrillated 4 times and received 4 epinephrine injections with a brief period of pulseless electrical activity (pea).The patient arrived to the hospital unresponsive and was intubated soon after arrival in the emergency room (er) and administered adenosine and amiodarone as part of standard routine resuscitation measures for approximately 60 minutes, with no success in resuscitating the patient labs drawn soon after arrival in er confirmed elevated troponin levels while serum potassium was reported at 3.9 meq/l, electrocardiogram (ecg) recording confirmed presence of a wide qrs rhythm, right bundle branch clock and left anterior fascicular block with t wave abnormality consistent with acute non-st elevation myocardial infarction (stemi) leading to a fatal outcome.Per the family¿s request resuscitation efforts were ended and the patient was pronounced dead at 15:59 pm.A review of all hd treatment information available for (b)(6) 2017 revealed the fresenius 2008t machine passed pressure holding test (pht) and machine alarm verification during pre-treatment set up.Additionally, the machine conductivity reading was verified with an independent meter and the dialysate ph was reported to with acceptable limits prior to the start of treatment.There were no reported machine issues encountered during pre-treatment hd set up ((b)(6) 2017) and no reported machine alarms at the time the patient event.The machine was returned to service for continued use without request for machine evaluation, machine repairs or further reported issues.

• Brand Name: FMC BLOODLINE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6944958
• MDR Text Key: 89152729
• Report Number: 8030665-2017-00831
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• 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?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/18/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR