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 Anemia (1706); Chest Pain (1776); Dyspnea (1816); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Hypovolemic Shock (1917); Ischemia (1942); Dizziness (2194); Diaphoresis (2452)

Event Date 08/01/2022

Event Type  Injury  

Event Description

It was reported via user facility medwatch (b)(4) that a hemodialysis (hd) patient using the fresenius optiflux 180nre dialyzer experienced an adverse event.The patient began experiencing shortness of breath (sob) coinciding with an external leak from the dialyzer.The patient was placed on oxygen, emergency medical services (ems) was notified, and the patient was transported to the hospital (via ambulance).The patient was admitted to the hospital with a hemoglobin of 8.3 and the patient required a transfusion of packed red blood cells (prbc) and intravenous fluids (ivf).The patient also required admittance into the cardiac intensive care unit (cicu) for ongoing medical management for additional medical issues.Additional details about the event were obtained through follow-up with the facility administrator (fa).On (b)(6) 2022 at 7:07 am, the patient¿s hemodialysis treatment was initiated without any documented issues or patient complaints.Additionally, it was reported there were no visible defects with the fresenius optiflux dialyzer in use for the treatment.At approximately 7:40 am, the patient began experiencing shortness of breath with report of visible blood (amount not quantified) on the floor.Additionally, the patient was noted to be clammy (diaphoretic) with thready pulse.Patient vitals recorded include blood pressure 138/106 with an apical pulse of 125.The patient was placed on 100% oxygen via facemask (fm) and pulse oximeter (pox) recorded at 99%.The patient¿s hemodialysis treatment was ended, and it was reported that the nurse caring for the patient noticed the optiflux dialyzer had significant leakage of saline upon returning the patient¿s blood through the dialysis circuit.The fa stated the optiflux dialyzer was discarded after the event and therefore was not available for manufacturer evaluation.At 7:44 am, repeat vital signs were obtained and recorded as blood pressure 154/56, and apical pulse 113 with note that patient was initially refusing ems/hospitalization.At 8:10 am, ems arrived in the facility and the patient agreed to go for further medical evaluation.The patient was transported to the emergency room (er) and noted in the discharge summary to have lost approximately 2 liters of blood (after becoming unhooked from the dialysis machine).However, it was confirmed through follow-up that the patent did not become unhooked from the dialysis machine.It was confirmed that the dialyzer was cracked and was leaking (leading to blood loss).Upon arrival to the er the patient was hypotensive and dizzy.An electrocardiogram (ekg) was obtained which revealed evidence of anterior ischemia.The patient¿s hemoglobin was 8.3, significant for acute blood loss anemia.The patient received ivf and prbc transfusion for volume replacement.However, the patient had developed subsequent episodes of chest pain and paroxysm of atrial flutter with a noted rise in troponin levels.Therefore, due to these events with an extensive past medical history (notably cardiovascular) the patient was admitted to the hospital and transferred to cicu for further medical management.The patient¿s course of treatment in the cicu was not contained in the discharge summary and details are unknown.The patient was discharged to a rehabilitation facility on (b)(6) 2022 with diagnoses of acute blood loss anemia, hemorrhagic shock, demand ischemia, supratherapeutic inr and end-stage renal disease (esrd) on hd.Subsequently, on (b)(6) 2022, the patient resumed hemodialysis treatments with the reporting facility.It was reported the patient has recovered and continues regularly scheduled hd without any issues.

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 the reported crack in the fresenius optiflux 180nre dialyzer and patient acute blood loss during a hd treatment which resulted in patient hospitalization.Currently, it is unknown what led to the reported crack in the dialyzer.It was stated the dialyzer in use was discarded and therefore will not be returned to manufacturer for further product analysis.However, there were no further reported dialyzer defects from the respective lot.Nonetheless, the fresenius optiflux 180nre dialyzer cannot be excluded as a factor in the patient¿s acute blood loss anemia, hemorrhagic shock, and demand ischemia which required blood transfusion and further medical management in the cardiac intensive care unit.However, the patient has since recovered from the event and continues regularly scheduled hemodialysis without any further reported issues.

Event Description

It was reported via user facility medwatch (b)(4).That a hemodialysis (hd) patient using the fresenius optiflux 180nre dialyzer experienced an adverse event.The patient began experiencing shortness of breath (sob) coinciding with an external leak from the dialyzer.The patient was placed on oxygen, emergency medical services (ems) was notified, and the patient was transported to the hospital (via ambulance).The patient was admitted to the hospital with a hemoglobin of 8.3 and the patient required a transfusion of packed red blood cells (prbc) and intravenous fluids (ivf).The patient also required admittance into the cardiac intensive care unit (cicu) for ongoing medical management for additional medical issues.Additional details about the event were obtained through follow-up with the facility administrator (fa).On 1/aug/2022 at 7:07 am, the patient¿s hemodialysis treatment was initiated without any documented issues or patient complaints.Additionally, it was reported there were no visible defects with the fresenius optiflux dialyzer in use for the treatment.At approximately 7:40 am, the patient began experiencing shortness of breath with report of visible blood (amount not quantified) on the floor.Additionally, the patient was noted to be clammy (diaphoretic) with thready pulse.Patient vitals recorded include blood pressure 138/106 with an apical pulse of 125.The patient was placed on 100% oxygen via facemask (fm) and pulse oximeter (pox) recorded at 99%.The patient¿s hemodialysis treatment was ended, and it was reported that the nurse caring for the patient noticed the optiflux dialyzer had significant leakage of saline upon returning the patient¿s blood through the dialysis circuit.The fa stated the optiflux dialyzer was discarded after the event and therefore was not available for manufacturer evaluation.At 7:44 am, repeat vital signs were obtained and recorded as blood pressure 154/56, and apical pulse 113 with note that patient was initially refusing ems/hospitalization.At 8:10 am, ems arrived in the facility and the patient agreed to go for further medical evaluation.The patient was transported to the emergency room (er) and noted in the discharge summary to have lost approximately 2 liters of blood (after becoming unhooked from the dialysis machine).However, it was confirmed through follow-up that the patent did not become unhooked from the dialysis machine.It was confirmed that the dialyzer was cracked and was leaking (leading to blood loss).Upon arrival to the er the patient was hypotensive and dizzy.An electrocardiogram (ekg) was obtained which revealed evidence of anterior ischemia.The patient¿s hemoglobin was 8.3, significant for acute blood loss anemia.The patient received ivf and prbc transfusion for volume replacement.However, the patient had developed subsequent episodes of chest pain and paroxysm of atrial flutter with a noted rise in troponin levels.Therefore, due to these events with an extensive past medical history (notably cardiovascular) the patient was admitted to the hospital and transferred to cicu for further medical management.The patient¿s course of treatment in the cicu was not contained in the discharge summary and details are unknown.The patient was discharged to a rehabilitation facility on 6/aug/2022 with diagnoses of acute blood loss anemia, hemorrhagic shock, demand ischemia, supratherapeutic inr and end-stage renal disease (esrd) on hd.Subsequently, on 2/sep/2022, the patient resumed hemodialysis treatments with the reporting facility.It was reported the patient has recovered and continues regularly scheduled hd without any issues.

Manufacturer Narrative

Plant investigation: the complaint device was not returned to the manufacturer for physical evaluation.However, two photos of the device were provided for review.Both photos show a close-up view of the header cap.Blood is present within the threads, and cracks are visible within the threaded area.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 one approved temporary deviation notice (dn) reported on the lot which was 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 lot met all release criteria.Based on the provided photos, the complaint is confirmed due to a cracked header.The probable cause for this failure to occur could be rough handling of the dialyzer during manufacturing, shipping, or by the end user.Since it is unknown when the damage may have occurred, the cause of the failure could not be established.Continuous improvement is of the utmost importance to fresenius medical care as we strive to provide dialysis products of the highest quality to our patients.Reports of leaking product are investigated both individually as complaints, as well as via the nc/capa program, in order to assess and improve our products and processes.Capas for vision systems and blood leak reduction are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.

• 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
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15567597
• MDR Text Key: 301477478
• Report Number: 0001713747-2022-00386
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• 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
• Device Lot Number: 22EU07008
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS COMBI SET BLOODLINES; FRESENIUS COMBI SET BLOODLINES; GRANUFLO 3.0K 2.5CA 1.0MG; GRANUFLO 3.0K 2.5CA 1.0MG; NORMAL SALINE; NORMAL SALINE
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Race: Black Or African American