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 Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); Anxiety (2328); Loss of consciousness (2418); Blood Loss (2597)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hd therapy utilizing the optiflux 180nre dialyzer and the serious adverse events of blood loss, hypotension, loss of consciousness, and anxiety which required hospital-based evaluation and monitoring.The reporter stated no defect(s) or damage was observed on the exterior of the optiflux 180nre dialyzer.However, evidence of a dialyzer membrane rupture was confirmed by the visualization of blood in the dialysate compartment.The etiology of the dialyzer membrane rupture, which preempted the events is unknown; therefore, causality cannot firmly be established.However (as reported by the cm), a physician (specialty not provided) deduced the patient became anxious due to the events and lost consciousness.While uncommon, blood leak events are a known potential complication of utilizing optiflux dialyzers during hd therapy.Based on the information available, the optiflux 180nre dialyzer cannot be disassociated from the events.Despite the physician¿s diagnosis of an anxiety attack precipitating the loss of consciousness, and given the lack of treatment records, discharge summary and no returned product for manufacturer evaluation.The optiflux 180nre cannot be excluded from having a possible causal or contributory role in the serious adverse events.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A user facility clinic manager (cm) reported that an internal dialyzer blood leak occurred at the beginning of a patient¿s hemodialysis (hd) treatment.The blood leak was reportedly visible in the dialysate compartment of the device.The machine, a fresenius 2008t, alarmed appropriately with a blood leak alert.Fresenius bloodlines were also being used.Blood test strips were not used; the cm stated the blood leak was obvious and the use of test strips was not necessary.There was no damage identified on the dialyzer.After the machine alarmed, the treatment was halted.The patient¿s blood was not returned; their estimated blood loss (ebl) was approximately 100 ml.Following the event, the patient became hypotensive and briefly lost consciousness.Cardiopulmonary resuscitative (cpr) measures were instituted, and the patient regained consciousness after only two compressions.Following the events, the patient was transported (specifics not provided) to the emergency room (er) for evaluation and observation.No medical intervention was provided in the er.Per the physician, it was determined the patient became very anxious, and panicked when the blood leak occurred.The cm stated the patient is spanish speaking only and communication during the events was difficult.The patient was discharged in stable condition (date not provided) and resumed their normal hd therapy schedule.The dialyzer was not available to be returned for a manufacturer evaluation as it was reportedly discarded, and the lot number for the device was unknown.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As no lot number was provided for this complaint, a search was performed to obtain all lot numbers with the reported catalog number delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date.Seven lots were found to have been delivered in this time period.A production records review was performed on the reported lots.An investigation of the device history records (dhr) was conducted by the manufacturer.There were one to multiple approved temporary deviation notices (dns) reported on three of the lots which were 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 lots 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.

• 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: 10480684
• MDR Text Key: 205272339
• Report Number: 1713747-2020-00365
• 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: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0500318E
• Device Catalogue Number: 0500318E
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 106