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

Model Number 0500318E

Device Problem Contamination (1120)

Patient Problems Adult Respiratory Distress Syndrome (1696); Cyanosis (1798); Confusion/ Disorientation (2553); Convulsion/Seizure (4406)

Event Date 07/30/2021

Event Type  Injury  

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 optiflux 180nre dialyzer and the adverse events of seizure, characterized by convulsion, facial cyanosis and rales during breathing.The source of the patient¿s seizure can be attributed to the patient¿s medical history of previously uncontrolled seizure activity as reported by a medical professional.Through peer reviewed studies, it is known the esrd population have higher incidents of neurological complications including seizure activity.Additionally, it was found there was no discernible relationship between seizure activity and hd therapy.Therefore, the optiflux 180nre dialyzer can be excluded as a root cause of this patient¿s adverse event.Based on the required information, there was no allegation or objective evidence any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse event.

Event Description

The clinical manager (cm) from a hemodialysis (hd) user facility reported that a patient experienced a seizure during their hd treatment.The patient was hypertensive at the beginning of the treatment which is their baseline due to comorbidities.There were no machine alarms during the treatment.Twenty-two minutes into the treatment, the patient began convulsing and the hd treatment was discontinued.The patient¿s lips and face became cyanotic, and rales were noted in their breathing.The patient was rolled laterally and 2l oxygen via nasal cannula was placed on the patient.The patient¿s seizure lasted a total time of 3 minutes and post-seizure, the patient appeared agitated, restless and unresponsive to commands.Emergency services were activated while the patient's blood was returned.There was no reported blood loss.The patient was transported to the emergency department (ed) and eventually released to home with no hospital admission.It was stated the patient has a medical history of seizures; however, the patient was not medicated for this condition.Following the ed visit, the patient was prescribed medication for their seizures (unknown type, route, dose and frequency).Following the event, the 2008t hd machine was sequestered for testing with the used bloodlines and dialyzer connected.The facility biomedical technician completed testing and reportedly found small unidentifiable insects in the header of the dialyzer.The disposable supplies were thoroughly inspected prior to use and no abnormalities were identified.The saline infusion bag used for priming was inspected before and after use, with confirmation of no contamination or infestation inside, on the surface, or around the saline bag.The 2008t machine passed testing, was disinfected and returned to service.There was no report of any relationship between the insects in the dialyzer head and the patient¿s seizure.The dialyzer was reportedly available to be returned for evaluation.

Manufacturer Narrative

Additional information: h3 plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no sample has been received.The third-party carrier¿s website was reviewed and it was confirmed that the fresenius-provided shipping materials were sent to the customer and subsequently received.There were three photos provided by the facility for review.One photo shows an up-close view of what appears to be a transparent, blackish particulate in the header cap of the dialyzer, and does not appear to be insect-like; however, a definitive conclusion could not be made without a physical evaluation of the sample.Another photo shows the dialyzer connected to the machine, and the last photo shows the case label of the bloodlines.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.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.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.Should the sample be returned at a later date, a supplemental report will be submitted capturing the updated investigation results.

Event Description

The clinical manager (cm) from a hemodialysis (hd) user facility reported that a patient experienced a seizure during their hd treatment.The patient was hypertensive at the beginning of the treatment which is their baseline due to comorbidities.There were no machine alarms during the treatment.Twenty-two minutes into the treatment, the patient began convulsing and the hd treatment was discontinued.The patient¿s lips and face became cyanotic, and rales were noted in their breathing.The patient was rolled laterally and 2l oxygen via nasal cannula was placed on the patient.The patient¿s seizure lasted a total time of 3 minutes and post-seizure, the patient appeared agitated, restless and unresponsive to commands.Emergency services were activated while the patient's blood was returned.There was no reported blood loss.The patient was transported to the emergency department (ed) and eventually released to home with no hospital admission.It was stated the patient has a medical history of seizures; however, the patient was not medicated for this condition.Following the ed visit, the patient was prescribed medication for their seizures (unknown type, route, dose and frequency).Following the event, the 2008t hd machine was sequestered for testing with the used bloodlines and dialyzer connected.The facility biomedical technician completed testing and reportedly found small unidentifiable insects in the header of the dialyzer.The disposable supplies were thoroughly inspected prior to use and no abnormalities were identified.The saline infusion bag used for priming was inspected before and after use, with confirmation of no contamination or infestation inside, on the surface, or around the saline bag.The 2008t machine passed testing, was disinfected and returned to service.There was no report of any relationship between the insects in the dialyzer head and the patient¿s seizure.The dialyzer was reportedly available to be returned for evaluation.

• 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; director, site quality; 475 west 13th street; ogden UT 84404
• MDR Report Key: 12351405
• MDR Text Key: 267648106
• Report Number: 1713747-2021-00277
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• Combination Product (y/n): N
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

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: 03/31/2024
• Device Model Number: 0500318E
• Device Catalogue Number: 0500318E
• Device Lot Number: 21CU07032
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 07/31/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 10/14/2021
• Supplement Dates FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 33 YR
• Patient Weight: 93