• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Death (1802); Blood Loss (2597)
Event Date 08/31/2020
Event Type  Death  
Manufacturer Narrative
Clinical investigation: a temporal relationship exists between crrt utilizing the optiflux 180nre dialyzer and the serious adverse events of blood loss and subsequent death. The patient was hospitalized for covid-19 and was suffering from aki which required crrt. Although no defect(s) or damage was observed on the exterior of the optiflux 180nre dialyzer pre-treatment; there is photographic evidence and nurse testimony the optiflux 180nre dialyzer showed evidence of a ¿crack¿ on the topmost portion of the dialyzer. Blood could be reportedly seen coming from the top of the dialyzer and collecting in a pool on the floor (volume unknown). The cause of the suspected product malfunction which preempted the events is unknown; therefore, causality cannot firmly be established. Additionally, the suspect product was discarded following the events and is unavailable for manufacturer evaluation and testing. While uncommon, blood leak events are a known potential complication of utilizing optiflux series dialyzers during rrt therapy; however, based on the information available, the optiflux 180nre dialyzer cannot be disassociated from the events. Blood was visualized coming from the topmost portion of the optiflux 180nre dialyzer, and the patient¿s death was precipitated by this event. Given these findings, in addition to the lack of treatment data, suspect product for evaluation, discharge summary, death certificate, and/or autopsy report. The optiflux 180nre is the probable cause of the patient¿s decompensation from blood loss and subsequent death. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
It was reported on (b)(6) 2020 that a fresenius optiflux 180nre dialyzer had a crack which resulted in a blood leak on (b)(6) 2020. The leak was noted to be coming from the top of the dialyzer which resulted in blood on the floor. It was further reported that the patient decompensated. Further information received by fresenius on (b)(6) 2020 stated that continuous renal replacement therapy (crrt) had been in progress for approximately 9 hours when a puddle of blood, as well as possible dialysate, was noted on the floor. The patients estimated blood loss was unknown. The patient ultimately suffered an adverse outcome and death. The blood leak was observed to be appearing from the top of the dialyzer end cap. Follow up with the user facility was conducted on (b)(6) 2020. The hospital¿s risk and regulatory department (rrd) confirmed the patient was hospitalized in the intensive care unit (icu) for covid-19 (specific dates not provided). The patient was also suffering from acute kidney injury (aki) due to covid-19 and was undergoing crrt. On (b)(6) 2020, the patient was receiving their 8th crrt treatment, when approximately 9 hours into therapy (reportedly nearing end of treatment) a blood leak was discovered. The estimated blood loss (ebl) was indeterminable due to dialysate mixing with blood on the floor, however the volume was substantial. When the leak was discovered, the patient¿s treatment was immediately discontinued and resuscitative measures were undertaken, including rapid reinfusion (specifics/timeline not provided); however, the patient was unable to be revived. The rrd initially reported the primary cause of death was listed as exsanguination; however, although an exact volume cannot be determined, the rrd stated the patient did not exsanguinate as previously stated. Per the rrd, the reported ebl was substantial enough to cause the patient to decompensate, which ultimately led to their death. The term exsanguinate is not an accurate representation of the facts as reported by the hospitals review committee. Additionally, the rrd stated that there were venous pressure alarms noted at several intervals leading up to the events, however they were unable to provide any further detail. Per the rrd, they are currently investigating if the alarms were an early indicator of the leak or just showing signs of clotting toward the end of treatment. The machine utilized during the reported events was a tablo hd machine (not a fresenius product). The rrd declined providing the treatment record and/or data from (b)(6) 2020, as it is an on-going investigation. The rrd reported the crrt machine was sequestered following the events and tablo performed their own internal investigation. Tablo reported the hd machine passed all functional compliance testing post events and performed as intended (per manufacturer specifications) during the events. The machine has since been returned to service. The hospitals patient safety committee is conducting an internal investigation into the events, including staff interviews, equipment review, and available resources. The rrd stated the hospital manages its own inpatient dialysis services and the fresenius optiflux series dialyzers are the hospital¿s standard dialyzer when performing crrt and have never encountered a problem before. The optiflux 180nre dialyzer was discarded following the events and is therefore unavailable for manufacturer evaluation; however, the rrd reported a picture was taken of the dialyzer following the events, showing the alleged crack. The picture is reportedly not the best quality and does not clearly show a crack, however it demonstrates there was blood/fluid escaping the enclosed system through the top portion of the optiflux 180nre dialyzer. Additionally, it was reported that companion samples were available to be returned to the manufacturer for investigation. A sample return kit was sent the user facility to obtain the companion samples.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10603728
MDR Text Key209112525
Report Number1713747-2020-00390
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 health professional,user faci
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0500318E
Device Catalogue Number0500318E
Device Lot Number20CU07035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received11/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2020
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: 09/29/2020 Patient Sequence Number: 1
-
-