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

Model Number 0500316E

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

Event Type  malfunction  

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 160nre dialyzer and the adverse events of blood loss and anemia.It is well established hd patients are at risk for hd emergencies; however, deleterious events and serious injuries are a rare occurrence.The patient¿s anemia diagnosed with both hospitalizations can be attributed to a preexisting chronic gi bleed.Gi bleeding is a known comorbidity in the esrd patient community and presents a challenge in keeping normal blood levels and preventing recurrent blood loss.Considering the minimal amount of blood loss and preexisting anemia due to a chronic gi bleed, the optiflux 160nre can be excluded as a cause or contributor to patient¿s adverse events.Based on the provided information, there is no specific allegation or objective evidence indicating that a fresenius device and/or product deficiency caused or contributed to the patient¿s adverse events.

Event Description

A user facility charge nurse (cn) reported that an internal dialyzer blood leak occurred less than one minute into a patient¿s hemodialysis (hd) treatment.Blood was visually observed in the dialysate compartment of the dialyzer.The machine, a fresenius 2008t, alarmed appropriately with a blood leak alert.A blood test strip was used and tested positive.No damage was identified on the dialyzer.Fresenius bloodlines were also being used for the treatment.After the machine alarmed, the treatment was halted.The patient¿s blood was not returned; estimated blood loss (ebl) was 300 ml.After the blood leak, labs were drawn and the patient presented a hemoglobin (hgb) of 6.3 g/dl, showing a deficit from an hgb taken two days prior that presented 8.7 g/dl.Despite the low hemoglobin, the patient remained asymptomatic with normal vital signs.The patient completed their hd treatment after being re-setup with new supplies on a different machine.The complaint device was reportedly available to be returned for a physical evaluation.Following the treatment, the patient¿s nephrologist ordered the patient be sent to the hospital for further testing.The patient was admitted to the hospital that same day, and continued hd therapy on a hospital provided hd machine (unknown brand and model) during the admission.The patient was diagnosed with anemia due to a chronic gastrointestinal (gi) bleed and there was no report the dialyzer blood leak caused or contributed to this event.The patient was discharged to their nursing home on 1/feb/2021.Following discharge, the patient was readmitted to the hospital on the 1/feb/2021 due to symptoms of shortness of breath and pallor in the nursing home.Labs drawn on 1/feb/2021 showed the patient¿s hgb had decreased to 5.5 g/dl.The patient was again diagnosed with anemia due to a chronic gi bleed.The patient was able to undergo hd therapy on a hospital provided hd machine (unknown brand and model) during this admission.At the time of follow-up, the patient was recovering from this event while awaiting discharge.

Event Description

A user facility charge nurse (cn) reported that an internal dialyzer blood leak occurred less than one minute into a patient¿s hemodialysis (hd) treatment.Blood was visually observed in the dialysate compartment of the dialyzer.The machine, a fresenius 2008t, alarmed appropriately with a blood leak alert.A blood test strip was used and tested positive.No damage was identified on the dialyzer.Fresenius bloodlines were also being used for the treatment.After the machine alarmed, the treatment was halted.The patient¿s blood was not returned; estimated blood loss (ebl) was 300 ml.After the blood leak, labs were drawn and the patient presented a hemoglobin (hgb) of 6.3 g/dl, showing a deficit from an hgb taken two days prior that presented 8.7 g/dl.Despite the low hemoglobin, the patient remained asymptomatic with normal vital signs.The patient completed their hd treatment after being re-setup with new supplies on a different machine.The complaint device was reportedly available to be returned for a physical evaluation.Following the treatment, the patient¿s nephrologist ordered the patient be sent to the hospital for further testing.The patient was admitted to the hospital that same day, and continued hd therapy on a hospital provided hd machine (unknown brand and model) during the admission.The patient was diagnosed with anemia due to a chronic gastrointestinal (gi) bleed and there was no report the dialyzer blood leak caused or contributed to this event.The patient was discharged to their nursing home on (b)(6) 2021.Following discharge, the patient was readmitted to the hospital on the (b)(6) 2021 due to symptoms of shortness of breath and pallor in the nursing home.Labs drawn on (b)(6) 2021 showed the patient¿s hgb had decreased to 5.5 g/dl.The patient was again diagnosed with anemia due to a chronic gi bleed.The patient was able to undergo hd therapy on a hospital provided hd machine (unknown brand and model) during this admission.At the time of follow-up, the patient was recovering from this event while awaiting discharge.

Manufacturer Narrative

The user facility had provided incorrect complaint device information in the initial reporting.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Manufacturer Narrative

Additional information: d9, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.The corporate provided blood port caps and adapter caps were returned attached to the dialyzer.There was blood noted throughout the dialyzer and in both head caps.The sample was returned damaged with a crack all the way around the bell housing on the non-cavity id end, and therefore could not be subjected to a laboratory bubble point leak test.The dialyzer was subjected to destructive disassembly for further visual examination.A fiber fragment was identified at approximately 45° on the cavity id end, with the dialysate ports positioned at 0°.The fiber fragment extended from the potting surface measuring approximately 0.43 mm in length under magnification (x20).The opposing end of the fiber fragment was not found.Further examination of the complaint device did not identify any other damage or irregularities.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 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.The investigation into the complaint was able to confirm the reported event.

Event Description

A user facility charge nurse (cn) reported that an internal dialyzer blood leak occurred less than one minute into a patient¿s hemodialysis (hd) treatment.Blood was visually observed in the dialysate compartment of the dialyzer.The machine, a fresenius 2008t, alarmed appropriately with a blood leak alert.A blood test strip was used and tested positive.No damage was identified on the dialyzer.Fresenius bloodlines were also being used for the treatment.After the machine alarmed, the treatment was halted.The patient¿s blood was not returned; estimated blood loss (ebl) was 300 ml.After the blood leak, labs were drawn and the patient presented a hemoglobin (hgb) of 6.3 g/dl, showing a deficit from an hgb taken two days prior that presented 8.7 g/dl.Despite the low hemoglobin, the patient remained asymptomatic with normal vital signs.The patient completed their hd treatment after being re-setup with new supplies on a different machine.The complaint device was reportedly available to be returned for a physical evaluation.Following the treatment, the patient¿s nephrologist ordered the patient be sent to the hospital for further testing.The patient was admitted to the hospital that same day, and continued hd therapy on a hospital provided hd machine (unknown brand and model) during the admission.The patient was diagnosed with anemia due to a chronic gastrointestinal (gi) bleed and there was no report the dialyzer blood leak caused or contributed to this event.The patient was discharged to their nursing home on (b)(6) 2021.Following discharge, the patient was readmitted to the hospital on the (b)(6) 2021 due to symptoms of shortness of breath and pallor in the nursing home.Labs drawn on (b)(6) 2021 showed the patient¿s hgb had decreased to 5.5 g/dl.The patient was again diagnosed with anemia due to a chronic gi bleed.The patient was able to undergo hd therapy on a hospital provided hd machine (unknown brand and model) during this admission.At the time of follow-up, the patient was recovering from this event while awaiting discharge.

• 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: 11324432
• MDR Text Key: 257172481
• Report Number: 1713747-2021-00046
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• 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,Followup
• Report Date: 04/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 0500316E
• Device Catalogue Number: 0500318E
• Device Lot Number: 20NU01014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Device Age: MO
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 62 YR
• Patient Weight: 74