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

Catalog Number 03-2722-9

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

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

Event Date 03/30/2016

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.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: the patient medical records were provided by the facility on july 12, 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.The patient medical records do not contain a history and physical for review.The patient was non-responsive upon admission to the hospital; therefore, no prior medical history was documented.Medical records suggest the patient had never been exposed to hemodialysis prior to (b)(6) 2016.The patient had no arteriovenous (av) fistula, hemodialysis catheter, a central catheter, or any type of venous port or peritoneal dialysis catheter upon admission.The medical records reveal that the patient was started on hemodialysis (hd) due to metabolic acidosis following cardiac arrest on (b)(6) 2016.The medical records reveal the patient¿s cardiac arrest on (b)(6) 2016 was possibly secondary to hyperkalemia.However, there is no documentation within the provided medical record that indicates an exact cause for the cardiac arrest.The patient was hypothermic on admission and the physician noted that the patient had been down for a while.The patient also presented with bacterial sepsis and the blood culture revealed actinomyces odontolyticus.In addition, the physician noted that the patient likely has ¿alcohol related hepatitis¿ based on the observed acute liver injury.The medical records further reveal patient poly-substance abuse for daily use of tobacco, cocaine, and alcohol.However, lab results revealed no illicit drugs in the patient¿s system upon admission.Additionally, the patient¿s ethanol (etoh) laboratory result showed a level of <6 which is considered normal.No death certificate was provided.The patient¿s medical records indicate that the (b)(6) 2016 cardiac arrest was not related to hemodialysis (hd).The patient underwent emergent hd on (b)(6) 2016, post cardiac arrest, without issue.No adverse event was noted during that hd therapy.On (b)(6) 2016, the patient experienced a cardiac arrest during the follow-up hd treatment.At that time, advanced cardiac life support (acls) was initiated, and the patient was administered epinephrine, bicarbonate and calcium gluconate.The patient¿s pulse and blood pressure returned, and dialysis was stopped.However, approximately 1 to 1.5 hours after the hd therapy was ended, the patient experienced a secondary episode of cardiac arrest.The patient received four (4) rounds of norepinephrine as well as four (4) attempts to shock via cardiac defibrillation (for heart rhythm of ventricular fibrillation) without success.The code continued for 15 minutes, however, the patient failed to regain a pulse, and therefore, was declared expired at 1:02pm with a cause of death listed as cardiac arrest and sepsis.There is no documentation in the medical record that indicates any causal relationship between the custom combi set and the patient¿s cardiac arrest and death.There is no documentation in the medical record that indicates a cause for the patient¿s two cardiac arrest episodes on (b)(6) 2016.Prior to the (b)(6) 2016 hd treatment, the patient was on a ventilator, in metabolic acidosis, was febrile with actinomyces odontolyticus sepsis, and in sinus tachycardia with an irregular heart rhythm.Prior to the (b)(6) 2016 hd treatment, the patient experienced cardiac arrest, where there was a period of time, that the patient was without a pulse and was not receiving intervention of any kind.Prior to the (b)(6) 2016 hd treatment, the patient¿s troponin level was critically high.All of the aforementioned circumstances were likely factors which contributed to the patient¿s cardiac arrest and subsequent death on (b)(6) 2016.

Event Description

On (b)(6) 2016, a biomedical technical manager (bmtm) from an acute hemodialysis (hd) facility telephoned technical support to request an on-site evaluation of a 2008k2 hd machine.The bmtm requested service for a machine that failed testing following a patient adverse event on (b)(6) 2016.Reportedly, the unit had a low ultrafiltration removal rate in dialysis mode.The bmtm further revealed that the machine did not generate any alarms during the hd treatment.Following the event, the unit was pulled from service for evaluation.Functional testing, which involved "3 separate tests" to check the ultrafiltration (uf), identified the uf rate as being low.However, no calibrations or repairs were attempted or performed by the on-site technicians.The unit remained out of service until the on-site evaluation performed by a fresenius regional equipment specialist (res) on june 24, 2016.The bmtm confirmed no alarms were expected for low ultrafiltration during the treatment.Functional testing performed by the res confirmed the system was operating properly.The device passed all functional and ultrafiltration testing.Therefore, no parts were replaced.The device remains out of service at the user facility pending its final release by the user facility.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.Follow-up with the user facility director of operations (do) was performed.The do indicated that there were no malfunctions of any other devices in use during this patient's hd treatment.The do provided additional event and patient details, as well as releasing relevant patient medical records for review.According to the do, the patient was not feeling well during the hd treatment performed on (b)(6) 2016.Approximately 1 to 1.5 hours later, the patient's "coded," and then expired.The medical records revealed that this male patient, with no history of chronic kidney disease, was admitted to the hospital on (b)(6) 2016, after experiencing an asystolic cardiac arrest at home with subsequent cardiopulmonary resuscitation (cpr) at the scene by emergency medical services (ems).The patient was comatose upon admission to the hospital.The patient was intubated, placed on a ventilator, and moved to the intensive care unit (icu) with an admitting diagnosis of cardiac arrest, metabolic acidosis, bacterial sepsis, polysubstance abuse, and alcoholism.A hemodialysis (hd) catheter was placed and emergent hd was performed on (b)(6) 2016 to correct the metabolic acidosis.The patient tolerated the hd treatment well and was scheduled for another a follow-up hd treatment on (b)(6) 2016.According to the hd treatment sheet for (b)(6) 2016, the patient was dialyzed in the medical icu.The patient was intubated, on a respirator, and receiving norepinephrine (norepi) via a "drip" at commencement of the treatment.Prior to initiation, a patient assessment revealed the patient was lethargic with visible "full body twitching." the patientheartbeat was reported as being "irregular" and rhythm was sinus tachycardia (sinus tach).Treatment was initiated at 9:20am via the hemodialysis (hd) catheter.Treatment time was ordered as 3.5 hours to remove 3.5l.Blood flow rate 250/dialysate flow rate 500.No heparin was prescribed.At 10:25am, the patient's blood pressure was 43/17 with a pulse of 48 beats per minute (bpm).Pulse was noted as being non-palpable.At that time, the treatment was discontinued, the blood within the extracorporeal circuit was returned, and cpr was initiated.Along with chest compressions, the patient received calcium gluconate and bicarbonate along with the administration of 3 rounds of epinephrine for concern of persistent hyperkalemia.The patient's pulse returned.Net fluid removal was 400ml.Upon treatment termination, the patient was described as "comatose." an emergency echocardiogram (ekg) was performed which revealed a severely dilated right ventricle.Post hemodialysis, at 12:35pm, the patient experienced another episode of bradycardia (30 beats per minute).Code blue was called and cpr with chest compressions was re-initiated.The patient received four (4) rounds of norepinephrine as well as four (4) attempts to shock via cardiac defibrillation (for heart rhythm of ventricular fibrillation) without success.The code continued for 15 minutes, however, the patient failed to regain a pulse, and therefore, was declared expired at 1:02pm with a cause of death listed as cardiac arrest and sepsis.

Manufacturer Narrative

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 bloodlines from the reported catalog number (03-2722-9) shipped to this account within the selected time frame.A records review was performed on the (b)(4) 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.

• Brand Name: CUSTOM COMBI SET
• 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: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5808953
• MDR Text Key: 50001554
• Report Number: 8030665-2016-00368
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Other Device ID Number: 00840861100293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2016
• 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; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 45