MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500318E

Device Problem Air Leak (1008)

Patient Problems Death (1802); Dyspnea (1816); Diaphoresis (2452)

Event Date 11/06/2017

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal association exists between the adverse events of the patient¿s increasing shortness of breath, becoming diaphoretic, blood loss, and the need for hospitalization and the 2008t hemodialysis (hd) machine, combi-set blood line, and optiflux 180nre dialyzer.However, the patient was conscious upon transfer of care from the clinic to ems.At some point during the transport to the er, the patient became unresponsive and hypertensive.Reportedly, the patient was placed on a nitroglycerine drip which caused a severe hypotensive episode requiring intubation.The patient was treated in the er and admitted to the icu where a complex sequence of events occurred including the development of acute respiratory distress syndrome and two instances of cardiac arrest with successful resuscitation.The patient was eventually made a ¿do not resuscitate¿ (dnr) and expired on (b)(6) 2017.It is unknown to what extent the hd treatment with the 2008t hd machine, combi-set blood line and optiflux 180nre dialyzer on (b)(6) 2017 contributed to the patient¿s decline and eventual demise as a death certificate or esrd death notification was not received.Although radiological testing provided no evidence of an embolism, per the report the possibility of the body could have absorbed any evidence of an embolism prior to testing does exist.The 2008t hd machine alarmed appropriately and as expected for the reported air leak.After the event, the machine was evaluated by the biomedical technician and found to be functioning appropriately and was returned to service.

Event Description

It was reported that a fresenius 2008t hemodialysis (hd) machine had alarmed for air detector and venous pressure within two minutes after the initiation of a patient¿s hd treatment on (b)(6) 2017.The patient became short of breath with wheezing and was given oxygen.At this time, treatment was interrupted, and small air bubbles were noted from the dialyzer and into the venous bloodline.The patient was re-set up with new supplies and resumed treatment on the same machine.After ten minutes, the patient had worsening shortness of breath and became diaphoretic.Following this, treatment was terminated, and the patient¿s blood was not returned.The estimated blood loss was 150ml.The patient was transported to the hospital via ambulance.While in the ambulance, the patient reportedly lost consciousness, was foaming at the mouth, and the patient¿s blood pressure was 300/180.The patient went into respiratory distress and was given a nitroglycerin drip.The ambulance technician reportedly spoke with the patient's doctor and it was suspected the patient had a possible air embolism.When the patient arrived at the emergency response (er) in the hospital, the patient was under stroke alert.The patient was intubated and had altered mental status due to hypertensive crisis.In the er, the patient received head and chest ct scans which revealed no acute intracranial findings and no findings to suggest acute pulmonary embolism or air embolism.However, the chest ct scan confirmed bilateral basilar consolidations with interstitial infiltrates.The patient¿s chest x-ray was also suggestive of congestive heart failure with pulmonary edema.The patient was subsequently admitted to the hospital on (b)(6) 2017 for acute hypoxemic and hypercapneic respiratory failure after intubation, pulmonary edema, hypertensive emergency, and acute toxic encephalopathy.After two days of being hospitalized, the patient was noted to be having worsening leukocytosis and developed acute respiratory distress syndrome.The patient had multiple episodes of being thrown and ventilated to improve oxygenation.The patient developed atrial flutter that was resistant to amiodarone infusion.On (b)(6) 2017, the patient underwent a cardioversion.While in the hospital, the patient had multiple hd treatments using a fresenius machine and all of fresenius products.There is currently no known issue with any hd treatments while hospitalized and no allegation of any defect or malfunction caused or contribute to the patient death.The patient¿s final diagnoses were acute respiratory distress syndrome with acute hypoxemic and hypercapnic respiratory failure, status post cardiac arrest, respiratory arrest, septic shock, transaminitis secondary to shock liver, gastrointestinal bleeding, end stage renal disease on hd, hypertensive emergency, acute toxic encephalopathy with concerns of anoxic brain injury, elevated troponins, most likely secondary to acute coronary syndrome, leukocytosis, and diabetes mellitus.The patient¿s neurological status never significantly improved after he was coded for cardiac arrest two times.The patient was eventually made do not resuscitate and expired (b)(6) 2017.It was reported that the 2008t hd machine in use at the time of the treatment had passed all self-tests prior to use.The machine was removed from service following the event for an evaluation by the facility¿s on-site biomedical technician (biomed).The biomed verified machine operations and did not make any repairs.The machine was returned to service at the user facility without issue.No defect or malfunction of any fresenius product in use during the hd treatment was observed or identified.No disposable devices are available to be returned to the manufacturing plant for physical evaluation as all products used for the patient¿s treatment on (b)(6)2017 have been discarded.

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer for physical evaluation.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint sample.A production records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There was one approved temporary deviation notice reported on the lot, which was unrelated to the reported complaint event.There was no indication of product deviations or non-conformances in rework, labeling, process controls, or any other occurrence in production identified during the manufacturing process which could be associated with the reported event.The sub-assembly production record review was completed for the fiber bundle, o-ring, polycarbonate molded components, and raw materials used in the production of the finished dialyzer lot.All materials were within acceptable parameters.Also, the reported dialyzer lot sub-assembly components were compared to the corresponding bill of materials.It was confirmed that the correct components were used during the manufacture of dialyzer lot 17lu02011.The reported lot number passed pyrogen testing, was within sterilization dosage parameters, and passed all release criteria.There is no evidence that a manufacturing problem exists to substantiate a causal relationship between the dialyzer and the reported event.As a sample has not been provided for evaluation, a definitive conclusion regarding the complaint incident cannot be determined.

• Brand Name: OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7130819
• MDR Text Key: 95310182
• Report Number: 1713747-2017-00403
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 0500318E
• Device Lot Number: 17LU02011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 12/20/2017
• Supplement Dates FDA Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2017
• 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
• Patient Weight: 101