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 Chest Pain (1776); Hemorrhage/Bleeding (1888)

Event Date 12/13/2023

Event Type  Injury  

Manufacturer Narrative

Plant investigation: 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 an optiflux 180nre dialyzer, and the serious adverse events of blood loss (approximately 400 ml) and chest pain, which required hospitalization, as the patient was actively undergoing treatment when the serious adverse events occurred.Per the hdrn, the patient¿s blood (darkened) was visualized inside the optiflux 180nre dialyzer (extending into the extracorporeal circuit), and a blood leak test strip was utilized to confirm its presence (no visible damage was noted on the interior/exterior of the dialyzer pretreatment).While uncommon, blood leak events are a known potential complication of utilizing optiflux series dialyzers during hd therapy.Based on the totality of the information available, the optiflux 180nre dialyzer cannot be excluded from having a causal role in the patient¿s serious adverse events (e.G., blood loss, chest pain, hospitalization).Given the hdrn¿s testimony/observations regarding the optiflux 180nre dialyzer¿s performance, and the pending manufacturer evaluation of the suspect product, this clinical investigation cannot disassociate the optiflux 180nre dialyzer from the serious adverse events.

Event Description

A user facility registered nurse (rn) reported a hemodialysis (hd) patient was on treatment for about one hour and a half when a blood leak alarmed.The rn stated blood appeared black in extracorporeal system.The rn tested the dialysate which tested positive for a blood leak.The patient's doctor informed to run the patient again with a new setup and machine.The rn stated thirty minutes into that treatment, a blood leak happened again.Upon follow-up, the rn stated the blood leaks were internal and occurred an hour and a half after initiation of the first treatment and thirty minutes after initiation of the second treatment.The machine, a 2008t, alarmed appropriately with blood leak alerts during both instances.The rn stated very dark, nearly black blood was visually observed within the dialyzers and in the in extracorporeal system during both instances.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 dialyzers prior to treatment.The estimated blood loss was 200 ml during both instances.Immediately following the first blood leak event, the patient was re-setup with new supplies on a different machine before the second blood leak occurred.The rn stated after cancelling the second treatment the patient complained of chest pain and was taken to the emergency room on (b)(6) 2023, where the patient currently remains hospitalized.Both machines were removed from service.The dialyzers were available to be returned for manufacturer evaluation.

Event Description

A user facility registered nurse (rn) reported a hemodialysis (hd) patient was on treatment for about one hour and a half when a blood leak alarmed.The rn stated blood appeared black in extracorporeal system.The rn tested the dialysate which tested positive for a blood leak.The patient's doctor informed to run the patient again with a new setup and machine.The rn stated thirty minutes into that treatment, a blood leak happened again.Upon follow-up, the rn stated the blood leaks were internal and occurred an hour and a half after initiation of the first treatment and thirty minutes after initiation of the second treatment.The machine, a 2008t, alarmed appropriately with blood leak alerts during both instances.The rn stated very dark, nearly black blood was visually observed within the dialyzers and in the in extracorporeal system during both instances.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 dialyzers prior to treatment.The estimated blood loss was 200 ml during both instances.Immediately following the first blood leak event, the patient was re-setup with new supplies on a different machine before the second blood leak occurred.The rn stated after cancelling the second treatment the patient complained of chest pain and was taken to the emergency room on (b)(6) 2023, where the patient currently remains hospitalized.Both machines were removed from service.The dialyzers were available to be returned for manufacturer evaluation.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.During the lot history review it was noted that there was one other complaint reported against the lot.The complaint is mentioned above and addresses an internal blood leak.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 two 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.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.

Event Description

A user facility registered nurse (rn) reported a hemodialysis (hd) patient was on treatment for about one hour and a half when a blood leak alarmed.The rn stated blood appeared black in extracorporeal system.The rn tested the dialysate which tested positive for a blood leak.The patient's doctor informed to run the patient again with a new setup and machine.The rn stated thirty minutes into that treatment, a blood leak happened again.Upon follow-up, the rn stated the blood leaks were internal and occurred an hour and a half after initiation of the first treatment and thirty minutes after initiation of the second treatment.The machine, a 2008t, alarmed appropriately with blood leak alerts during both instances.The rn stated very dark, nearly black blood was visually observed within the dialyzers and in the in extracorporeal system during both instances.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 dialyzers prior to treatment.The estimated blood loss was 200 ml during both instances.Immediately following the first blood leak event, the patient was re-setup with new supplies on a different machine before the second blood leak occurred.The rn stated after cancelling the second treatment the patient complained of chest pain and was taken to the emergency room on (b)(6) 2023, where the patient currently remains hospitalized.Both machines were removed from service.The dialyzers were available to be returned for manufacturer evaluation.

• 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: 18427565
• MDR Text Key: 331866321
• Report Number: 0001713747-2024-00003
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2024

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: 23LU02001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 02/06/2024; 03/08/2024
• Supplement Dates FDA Received: 02/06/2024; 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2023
• 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 BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 71 KG