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

Model Number 0500318N

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

Patient Problem Loss of consciousness (2418)

Event Date 04/04/2022

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 relationship exists between hd therapy utilizing the fresenius optiflux 180nr dialyzer, and the serious adverse events of feeling unwell, loss of consciousness, pulselessness, and subsequent death.The death certificate, end-stage renal disease (esrd) death notification and autopsy report were unavailable during this investigation; therefore, the definitive etiology of the events cannot be firmly established.However, the patient was actively undergoing hd therapy when the events occurred.The esrd population continues to have significantly higher mortality (up to 30-fold higher), and fewer expected years of life when compared to the general population.Based on the totality of the information available, the fresenius optiflux 180nr dialyzer cannot be excluded from having a possible causal and/or contributory role in the patient¿s serious adverse events.While uncommon, hypersensitivity reactions are known to occur with the use of optiflux dialyzers and/or other elements in the extracorporeal circuit.Additionally, hypersensitivity reactions have been known to occur days, months, even years after use with the same dialyzer model.

Event Description

It was reported that a hemodialysis (hd) patient ¿feeling unwell,¿ loss of consciousness, pulselessness, and subsequent death on (b)(6) 2022.The patient arrived at their outpatient dialysis clinic on (b)(6) 2022 for his regularly scheduled treatment, and the patient¿s pre-treatment vitals included a b/p = 108/68 (sitting), 103/67 (standing), pulse = 93 bpm, respirations = 16 per min, temperature = 96.4, oxygen saturation = 94% and a pre-treatment weight of (b)(6) kgs.The treatment was initiated at 6:18 am (ultrafiltration goal = 3.5 kgs as tolerated) and terminated at 6:23 am after the patient complained of not feeling well.While the registered nurse (rn) was assessing the patient, they became unresponsive (it is unknown if the patient¿s blood was returned) and a pulse could not be palpated.The patient was placed in the trendelenburg position, emergency medical services (ems) was contacted, and the code cart was retrieved.Cardiopulmonary resuscitative (cpr) measures were instituted, and an automated external defibrillator (aed) was applied.No shock was advised, and cpr was continued until ems arrived at 6:30 am.Ems coded the patient (specifics not provided) until 7:06 am at which time the patient was pronounced dead.The patient received a total of 1800 ml of ns during the code, and the 2008t hemodialysis machine was sequestered following the serious adverse events.During post-event functional compliance testing, the 2008t hemodialysis performed as expected per the manufacturers¿ specifications.Additionally, a review of the water validation testing did not reveal any abnormal values.The dialyzer used during treatment was reportedly available to be returned for evaluation.

Manufacturer Narrative

Additional information: d4, d9, h4 the plant investigation is still in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that a hemodialysis (hd) patient ¿feeling unwell,¿ loss of consciousness, pulselessness, and subsequent death on (b)(6) 2022.The patient arrived at their outpatient dialysis clinic on (b)(6) 2022 for his regularly scheduled treatment, and the patient¿s pre-treatment vitals included a b/p = 108/68 (sitting), 103/67 (standing), pulse = 93 bpm, respirations = 16 per min, temperature = 96.4, oxygen saturation = 94% and a pre-treatment weight of 140.7 kgs.The treatment was initiated at 6:18 am (ultrafiltration goal = 3.5 kgs as tolerated) and terminated at 6:23 am after the patient complained of not feeling well.While the registered nurse (rn) was assessing the patient, they became unresponsive (it is unknown if the patient¿s blood was returned) and a pulse could not be palpated.The patient was placed in the trendelenburg position, emergency medical services (ems) was contacted, and the code cart was retrieved.Cardiopulmonary resuscitative (cpr) measures were instituted, and an automated external defibrillator (aed) was applied.No shock was advised, and cpr was continued until ems arrived at 6:30 am.Ems coded the patient (specifics not provided) until 7:06 am at which time the patient was pronounced dead.The patient received a total of 1800 ml of ns during the code, and the 2008t hemodialysis machine was sequestered following the serious adverse events.During post-event functional compliance testing, the 2008t hemodialysis performed as expected per the manufacturers¿ specifications.Additionally, a review of the water validation testing did not reveal any abnormal values.The dialyzer used during treatment was reportedly available to be returned for evaluation.

Manufacturer Narrative

Additional information: d9, g1, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.The dialyzer was returned with corporate provided adapter caps attached as well as the bloodlines.The dialyzer fibers were wet with evidence of blood exposure.The returned sample was visually inspected and there were no damages or irregularities noted on the device.The sample could not be forwarded for performance testing as it was exposed to blood.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was then conducted by the manufacturer.There was one approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.According to the clinical investigation, "a temporal relationship exists between hd therapy utilizing the fresenius optiflux 180nr dialyzer, and the serious adverse events of feeling unwell, loss of consciousness, pulselessness, and subsequent death." it also states, "based on the totality of the information available, the fresenius optiflux 180nr dialyzer cannot be excluded from having a possible causal and/or contributory role in the patient¿s serious adverse events." in conclusion, there were no known malfunctions that could have caused or contributed to the reported event and an associated cause could not be established.

Event Description

It was reported that a hemodialysis (hd) patient ¿feeling unwell,¿ loss of consciousness, pulselessness, and subsequent death on (b)(6) 2022.The patient arrived at their outpatient dialysis clinic on (b)(6) 2022 for his regularly scheduled treatment, and the patient¿s pre-treatment vitals included a b/p = 108/68 (sitting), 103/67 (standing), pulse = 93 bpm, respirations = 16 per min, temperature = 96.4, oxygen saturation = 94% and a pre-treatment weight of 140.7 kgs.The treatment was initiated at 6:18 am (ultrafiltration goal = 3.5 kgs as tolerated) and terminated at 6:23 am after the patient complained of not feeling well.While the registered nurse (rn) was assessing the patient, they became unresponsive (it is unknown if the patient¿s blood was returned) and a pulse could not be palpated.The patient was placed in the trendelenburg position, emergency medical services (ems) was contacted, and the code cart was retrieved.Cardiopulmonary resuscitative (cpr) measures were instituted, and an automated external defibrillator (aed) was applied.No shock was advised, and cpr was continued until ems arrived at 6:30 am.Ems coded the patient (specifics not provided) until 7:06 am at which time the patient was pronounced dead.The patient received a total of 1800 ml of ns during the code, and the 2008t hemodialysis machine was sequestered following the serious adverse events.During post-event functional compliance testing, the 2008t hemodialysis performed as expected per the manufacturers¿ specifications.Additionally, a review of the water validation testing did not reveal any abnormal values.The dialyzer used during treatment was reportedly available to be returned for evaluation.

• 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; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 14215016
• MDR Text Key: 290137170
• Report Number: 0001713747-2022-00145
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0500318N
• Device Catalogue Number: 0500318N
• Device Lot Number: 21PU04012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2021
• 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
• Treatment: FRESENIUS 2008T MACHINE.; FRESENIUS 2008T MACHINE.; FRESENIUS 2008T MACHINE.
• Patient Outcome(s): Required Intervention; Death
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 132 KG