MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA COMBISET ACCESS FLOW REVERSE CON TWISTER; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number 03-2794-0

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

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

Event Date 03/07/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The post market surveillance department received medical records associated with the reported event.Both a clinical investigation and plant investigation are in process.A supplemental mdr will be submitted upon completion of these activities.Additional medwatch reports are being submitted for the other fresenius products in use at the time of the event; 2008t hemodialysis machine and dialyzer.

Event Description

A user facility reported that a patient expired following a hemodialysis (hd) treatment.The patient's hd treatment initiated at 7:04 am est.At approximately 10:00 am est, the patient reported cramping of the lower extremities and requested that the treatment be ended early.At approximately 10:10 am est, while the blood was being rinsed back, the patient became unresponsive.The patient was placed in trendelenburg position with legs elevated at a 90 degree angle.10cc was pulled from arterial and venous lines and then a 250ml bolus of normal saline (ns) was administered through the arterial access port.An aed was applied to analyze rhythm, and shock was not advised.At the same time, oxygen was administered via ambu-bag with cardiopulmonary resuscitation (cpr), and an additional 500ml ns bolus was administered.The paramedics arrived approximately 10:30 am est, the care was transferred to the ems team, and then the patient was transferred to the hospital.Follow-up information was provided which revealed that frothy air bubbles were observed in the fistula line.No damage visible to the bloodline, dialyzer, or the 2008t hd machine.The nurse removed the blood lines in an attempt to aspirate the line.The machine alarmed air detector approximately 10 minutes before the event and the air detector clamp engaged.The alarm was able to be cleared.The patient's estimated blood loss was approximately 250-300cc.The reported cause of death was cardiac arrest.Following this event, the machine was pulled from the floor for evaluation.Functional testing performed by the biomed confirmed that the unit was operating properly.The unit remains at the user facility.The dialyzer and bloodline are available for evaluation by the manufacturer.

Manufacturer Narrative

Manufacturing evaluation: the device was returned to the manufacturer for physical evaluation.A visual examination of the returned device found the arterial and venous lines to be intact and properly assembled.The bloodline tubing did not reveal any pin holes or other damage.The bloodline was subjected to laboratory air leak test.The arterial and venous lines were pressurized with air to 15 psi and then submerged in water.No air bubbles or leaks observed.The device was then tested using a 2008t hemodialysis machine for simulated use.During the simulated use test, there were no observations of a disconnection or leak from the patient venous and arterial connectors to fistula.The twister was rotated two hours into the test, and no air bubbles occurred in the system.Additionally, no leaks, level variations of venous and arterial chambers, or any alarms were generated during the simulated use testing.The device worked as intended with no noted abnormalities and no defects were identified.A records review was performed on the reported lot.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 lot passed all release criteria.The investigation into the cause of the reported problem was not able to confirm the failure mode.The reported defect of tubing air leak was not confirmed.Analysis of the complaint device did not identify any damage, irregularities, or defects that would affect the integrity or performance of the bloodline.Therefore, this complaint has been deemed not confirmed.Clinical investigation: the patient medical records were provided by the facility on march 23, 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.There is no documentation in the medical record supporting a possible association between the fresenius dialysis products, the event of cardiopulmonary arrest, and the outcome of death.The received medical records did not contain a death certificate or an autopsy report.Further information has been solicited.

Event Description

The hemodialysis orders from (b)(6) 2016 included the following: optiflux f180nre dialyzer, 2 potassium, 2.5 calcium, 1 magnesium, 100 dextrose, sodium 137meq/l, bicarbonate machine setting 35, estimated dry weight 72kgs, dialysate flow rate 600ml/min, blood flow rate 400, scheduled time 3.5 hours.Fresenius 2008t hemodialysis machine settings for (b)(6) 2016 included the following: conductivity 13.4, meter conductivity 13.6, ph 7.0, machine temperature 36.7 degrees celsius, norla venous line enabled, pressure holding test passed, high flux verified, air detector armed, alarms verified, bleach yes.At 7:00 am, the patient was administered 1,000 units heparin bolus via intravenous push (ivp).At 7:03 am, hd treatment was initiated.At 9:19 am, the patient was administered venofer 100mg via ivp and calcitriol 0.750mcg via oral route.At 1008, the treatment was ended 32 minutes early due to patient request and the ultrafiltration goal achieved was net negative 2l.Upon arriving to the hospital, the patient was intubated, unresponsive, pulse-less, pupils fixed and dilated, a lucas machine in motion, advanced cardiac life support (acls) protocol was continued for 20 minutes, return of spontaneous circulation occurred, and acls protocol was discontinued.10-15 minutes later, the patient again experienced cardiopulmonary arrest, acls protocol was initiated, 10 minutes later, the patient status was switched to a do not resuscitate (dnr) status by family members, and the acls was discontinued.The patient was pronounced dead at 1148.

• Brand Name: COMBISET ACCESS FLOW REVERSE CON TWISTER
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• 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: 5582271
• MDR Text Key: 42818961
• Report Number: 8030665-2016-00182
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 03-2794-0
• Device Lot Number: 15LR01045
• Other Device ID Number: 00840861100316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2015
• 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
• Patient Age: 71 YR
• Patient Weight: 72