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

Catalog Number 0500318N

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

Patient Problems Cardiac Arrest (1762); Death (1802); Loss of consciousness (2418)

Event Date 04/13/2017

Event Type  Death  

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed and a definitive conclusion regarding the complaint incident cannot be reached as the complaint device was not available for manufacturer evaluation.An investigation of the device manufacturing records for the lot 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.Furthermore, a review was performed on the sub-assembly lot numbers used in the production of the finished lot.All materials used in finished lot production, including the fiber bundle, o-ring, and polycarbonate molded components were found to be within acceptable parameters and passed all release criteria.The review of the batch production record did not reveal a probable cause for the customer complaint.Clinical investigation: a clinical investigation was performed to identify a causal relationship between the hemodialysis (hd) treatment and the adverse event.Based on the provided medical records, a temporal association between the patient becoming unresponsive, requiring resuscitation measures, expiration, and the 2008t machine and other fresenius products exists.However, there is no documentation provided to indicate a causal relationship with the adverse events of the patient becoming unresponsive, requiring resuscitation measures, expiration, and the 2008t machine and other fresenius products.It is likely that the patient¿s recent myriad of medical issues and complex comorbid conditions (fractured and surgically repaired hip, worsening anasarca, hypoxemia, and dyspnea) put the patient at risk of sudden death.Additionally, there is no allegation and no indication of a malfunction or defect against any fresenius products.The hd machine was evaluated by the biomed and no repairs were needed.

Event Description

A clinic manager at a user facility reported that during a hemodialysis (hd) treatment on (b)(6) 2017, approximately 7 minutes after the initiation of treatment, the patient lost consciousness and became unresponsive.Cardiopulmonary resuscitation (cpr) efforts were initiated and the facility called emergency medical services (ems).Ems personnel transferred the patient to emergency care at a medical center, who later notified the facility of the patient¿s death.Follow-up information revealed that the patient had initially been admitted to the hospital on (b)(6) 2017 for aggressive wound treatment of the left foot and had been prepped for hd therapy for aggressive volume removal and uremic toxin removal.Prior to the hospitalization, the patient had been at a rehabilitation center for almost a month following a right hip fracture with surgical repair.However, the patient had worsening anasarca, hypoxemia, dyspnea on exertion requiring supplemental oxygen, and weakness leading to the hospitalization of (b)(6) 2017.During the hospitalization, the patient had weakness, fatigue, shortness of breath, dyspnea on exertion, orthopnea, foamy urine, 4+ edema (left greater then right), weeping on dorsum of right foot and open sores, left foot cellulitis, hiccoughs and myoclonic jerking, and uremic symptoms.On (b)(6) 2017, a right internal jugular central venous catheter (cvc) was placed for hd therapy.The patient was discharged from the hospital on (b)(6) 2017.On (b)(6) 2017 at 10:40 am, the patient arrived at the user facility for the first hd treatment.The pre-treatment evaluation was as follows: cardiac rhythm: regular, normal rate, respiratory: lungs clear bilaterally, the patient was described as pleasant, using a wheel chair to ambulate, with non-symptoms of fluid overload, +1 to 2 mm or less bilaterally of lower leg, ankle and foot edema that disappears rapidly, wound dressing to left foot intact; vital signs: blood pressure (b/p) 135/45, pulse 60 regular, respiratory rate 16 afebrile, temperature 97.5°f, pre-weight (b)(6).At the start of the hd treatment at 11:23 am, the patient¿s b/p was 141/58, pulse rate was 60 beats per minute (bpm), and 250ml normal saline (nacl) was administered.Seven minutes later, the nurse attempted to obtain the patient¿s oxygen (o2) saturation but the patient was pulling off the nasal cannula.The patient suddenly lost consciousness and became unresponsive.The patient was placed in trendelenburg, cpr was initiated, the patient¿s blood was returned, and ems was called.Automated external defibrillator (aed) pads were applied to the patient and analyzed with no shock advised.Cpr resumed using an ambu bag.At 11:40 am, ems personnel arrived with cpr still in progress.Aed analyzed a second time with no shock advised.Emergency medications (unknown type and dose) were given per ems protocol through the patient¿s cvc.The patient was intubated by ems and was transferred to the care of ems.The medical center notified the facility of the patient expiration on (b)(6) 2017.The cause of death was reported as cardiac arrest.It was reported that the 2008t hd machine in use at the time of the treatment did not alarm or provide any errors prior to treatment or at the time of the incident.The 2008t hd 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 malfunction of any fresenius product in use during the hd treatment was alleged, observed, or identified prior to, during, or following the event.The dialyzer is not available for evaluation by the manufacturer as it was discarded by the user facility.No samples of the acid/bicarb in use during the treatment are available for analysis.

• Brand Name: OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
• 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: 6667994
• MDR Text Key: 78444302
• Report Number: 1713747-2017-00218
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100125
• UDI-Public: 00840861100125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002277
• 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: 06/26/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 0500318N
• Device Lot Number: 16CU04013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2016
• 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; Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 65