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 Problem Fall (1848)

Event Date 12/09/2023

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: there is a temporal and likely causal relationship between use of the optiflux 180nre dialyzer for a patient treatment and the reported leak of normal saline with a staff member¿s fall and injury due to the unknown leak.The nurse requires the use of crutches and is out of work due to the injury.The reported leak originated from the dialyzer end cap; however, the product was discarded and cannot be returned to the manufacturer for evaluation.It was reported that no defect or damage was noted on the dialyzer.It is unknown if the staff made a connection in the dialysis system that was loose, which caused the leak or if in fact the dialyzer itself was the cause of the leak.Without the actual dialyzer to evaluate, the origin of the leak cannot be confirmed.Based on the available information, the alleged optiflux 180nre dialyzer end cap leak is likely the cause of the fall and resulting injury to the clinic staff member.Should additional information become available related to a fresenius device(s) and/or product(s), please re-submit for a clinical review and the need for a clinical investigation will be reassessed accordingly.

Event Description

On 11/dec/2023 it was reported that the end cap on the optiflux 180nre dialyzer was leaking normal saline (ns).The nurse was unaware of the leak and fell resulting in an injury to her knee.Additional information was obtained through follow-up with the clinical coordinator (cc).On 09/dec/2023 during the priming of a hemodialysis (hd) treatment, the dialyzer leaked ns from the end cap.The nurse was unaware of the leak and fell.The nurse was in a tremendous amount of pain after the event.The nurse¿s knee was too swollen for x-ray imaging to be completed.The nurse is utilizing crutches and is currently out of work on leave.No defect or damage was noted on the dialyzer.The dialyzer was discarded and not available 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 addresses an external header leak (no sample).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.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

On 11/dec/2023, it was reported that the end cap on the optiflux 180nre dialyzer was leaking normal saline (ns).The nurse was unaware of the leak and fell resulting in an injury to her knee.Additional information was obtained through follow-up with the clinical coordinator (cc).On (b)(6) 2023, during the priming of a hemodialysis (hd) treatment, the dialyzer leaked ns from the end cap.The nurse was unaware of the leak and fell.The nurse was in a tremendous amount of pain after the event.The nurse¿s knee was too swollen for x-ray imaging to be completed.The nurse is utilizing crutches and is currently out of work on leave.No defect or damage was noted on the dialyzer.The dialyzer was discarded and not available 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: 18359554
• MDR Text Key: 330910879
• Report Number: 0001713747-2023-00868
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

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: 23NU03004
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2023
• 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 HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
• Patient Outcome(s): Required Intervention
• Patient Sex: Female