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U.S. Department of Health and Human Services

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

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OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 0500318E
Device Problem Fluid 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.
 
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Brand NameOPTIFLUX 180NRE DIALYZER FINISHED ASSY.
Type of DeviceDIALYZER, 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
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key10480684
MDR Text Key205272339
Report Number1713747-2020-00365
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received09/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0500318E
Device Catalogue Number0500318E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received09/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/01/2020 Patient Sequence Number: 1
Treatment
FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES
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