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

Catalog Number 0500318E

Device Problem Fluid/Blood Leak (1250)

Patient Problems Dyspnea (1816); Hemorrhage/Bleeding (1888); Low Oxygen Saturation (2477)

Event Date 04/12/2024

Event Type  Injury  

Event Description

A user facility clinic manager (cm) reported a blood leak in the dialyzer and the red hansen line noted during a patient's hemodialysis (hd) treatment.Upon follow-up, the cm confirmed the blood leak was internal and occurred 2 hours and 15 minutes after initiation of treatment.The machine, a 2008t, alarmed appropriately with a blood leak alert.Blood was visually observed within the dialyzer housing and within the red hansen line.Blood test strips were used and tested positive for the presence of blood.The patient was utilizing fresenius bloodlines.No damage was noted on the dialyzer prior to treatment.The estimated blood loss was 150 ml.Immediately following the event, the patient was re-setup with new supplies on a different machine but did not complete treatment as the patient's oxygen saturation dropped and reported shortness of breath, and the patient was provided oxygen.Per cm the patient's hemoglobin level was adequate at 12.4 g/dl pre-treatment and 12.0 g/dl post-treatment.The patient was taken to the hospital for bloodwork and was discharged and not admitted.The machine has remained in service.The dialyzer was available to be returned for manufacturer evaluation additional information was obtained through follow-up with the clinical manager.This hd patient arrived for a regularly scheduled treatment on 12/apr/2024.The treatment was scheduled for four hours and initiated at 7:08am utilizing a fresenius 2008t machine, an optiflux 180nre dialyzer, and fresenius bloodlines.The blood flow rate (bfr) was set to 450 ml/min and the dialysate flow rate (dfr) was set to autoflow 1.5x ml/min.Approximately 2 hours and 15 minutes into the treatment, the machine alarmed with a blood leak alert.The blood leak was internal.Blood was visually observed within the dialyzer housing and within the red hanson line.Blood test strips were utilized and tested positive for the presence of blood.No damage had been visually noted on the dialyzer prior to treatment initiation.The patient¿s estimated blood loss (ebl) was 150ml.Immediately following the blood leak event, the patient was re-setup on a different machine with new supplies.However, the treatment was terminated with 2 hours and 10 minutes remaining.The patient¿s oxygen saturation dropped, and the patient reported being short of breath.The patient was administered supplemental oxygen at 3l/min via nasal cannula.The patient was transported to the hospital for assessment and bloodwork.No additional medical intervention was administered, and the patient was discharged.The patient¿s hemoglobin was adequate with pre-treatment value at 12.4 g/dl and 12.0 g/dl post-treatment.The patient had no additional complaints or complications.The patient returned to regularly scheduled hd treatments on 15/apr/2024.The dialyzer is being returned to the manufacturer for evaluation.The machine has remained in service.

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal relationship between hd therapy utilizing the optiflux 180nre dialyzer and the reported dialyzer blood leak resulting in patient blood loss with a drop in oxygen saturation with shortness of breath requiring the administration of supplemental oxygen.Additionally, there is likely a causal relationship between the blood loss requiring the supplemental oxygen and assessment with bloodwork at the hospital which occurred during the patient¿s treatment.Although the dialyzers have not been evaluated by the manufacturer at this time, it was reported that the hd machine alarmed appropriately for a blood leak and the test strips were positive for the presence of blood resulting in the patient¿s blood not being returned.As a consequence of the dialyzer blood leak, the patient required medical intervention due to a drop in oxygen saturation and shortness of breath.Based on the available information the optiflux 180nre dialyzer blood leak caused the patient blood loss with subsequent drop in oxygen saturation and shortness of breath.

Event Description

A user facility clinic manager (cm) reported a blood leak in the dialyzer and the red hansen line noted during a patient's hemodialysis (hd) treatment.Upon follow-up, the cm confirmed the blood leak was internal and occurred 2 hours and 15 minutes after initiation of treatment.The machine, a 2008t, alarmed appropriately with a blood leak alert.Blood was visually observed within the dialyzer housing and within the red hansen line.Blood test strips were used and tested positive for the presence of blood.The patient was utilizing fresenius bloodlines.No damage was noted on the dialyzer prior to treatment.The estimated blood loss was 150 ml.Immediately following the event, the patient was re-setup with new supplies on a different machine but did not complete treatment as the patient's oxygen saturation dropped and reported shortness of breath, and the patient was provided oxygen.Per cm the patient's hemoglobin level was adequate at 12.4 g/dl pre-treatment and 12.0 g/dl post-treatment.The patient was taken to the hospital for bloodwork and was discharged and not admitted.The machine has remained in service.The dialyzer was available to be returned for manufacturer evaluation.Additional information was obtained through follow-up with the clinical manager.This hd patient arrived for a regularly scheduled treatment on 12/apr/2024.The treatment was scheduled for four hours and initiated at 7:08am utilizing a fresenius 2008t machine, an optiflux 180nre dialyzer, and fresenius bloodlines.The blood flow rate (bfr) was set to 450 ml/min and the dialysate flow rate (dfr) was set to autoflow 1.5x ml/min.Approximately 2 hours and 15 minutes into the treatment, the machine alarmed with a blood leak alert.The blood leak was internal.Blood was visually observed within the dialyzer housing and within the red hanson line.Blood test strips were utilized and tested positive for the presence of blood.No damage had been visually noted on the dialyzer prior to treatment initiation.The patient¿s estimated blood loss (ebl) was 150ml.Immediately following the blood leak event, the patient was re-setup on a different machine with new supplies.However, the treatment was terminated with 2 hours and 10 minutes remaining.The patient¿s oxygen saturation dropped, and the patient reported being short of breath.The patient was administered supplemental oxygen at 3l/min via nasal cannula.The patient was transported to the hospital for assessment and bloodwork.No additional medical intervention was administered, and the patient was discharged.The patient¿s hemoglobin was adequate with pre-treatment value at 12.4 g/dl and 12.0 g/dl post-treatment.The patient had no additional complaints or complications.The patient returned to regularly scheduled hd treatments on 15/apr/2024.The dialyzer is being returned to the manufacturer for evaluation.The machine has remained in service.

Manufacturer Narrative

The complaint device was returned to the manufacturer for physical evaluation.During gross visual examination, a delamination was observed to be extending from approximately 290° to 45° with the ports at 0° on the non-cavity id end.Further visual examination did not identify any other damage or irregularities on the returned sample.During the lot history review it was noted that there was no other complaint reported against the lot.The number of complaints for the assigned symptom code on the lot number was reviewed and it was determined that no lot complaint excursion occurred.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There were multiple approved temporary deviation notices (dn) reported on the lot 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 lot met all release criteria.The investigation into the complaint was able to confirm the reported event.

• 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: 19144015
• MDR Text Key: 340616437
• Report Number: 0001713747-2024-00318
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0500318E
• Device Lot Number: 24BU02015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Device Age: MO
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2024
• 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 BLOODLINES; FRESENIUS BLOODLINES
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 72 KG