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 Fall (1848); Insufficient Information (4580)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

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 while attempting to mop up the fluid from the leak.The ccht required medical intervention for a possible broken wrist requiring physical therapy, work restrictions, and the wearing of a brace.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.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A user facility clinical coordinator (cc) reported that the end cap of the dialyzer was leaking during prime.A certified clinical hemodialysis technician (ccht) discovered the dialyzer leak upon observing normal saline (ns) on the floor.The ccht fell and was injured while attempting to mop the saline.Additional information was obtained through follow-up with the cc.On (b)(6) 2023 during the priming of a hemodialysis (hd) treatment, the dialyzer leaked ns from the end cap.The ccht fell while attempting to mop the fluid.The ccht sought medical attention and it is suspected that they have a broken wrist.The ccht is going to physical therapy three times per week for the injury and has returned to work with a brace and job restrictions (unspecified) in place.The ccht has declined pain medication.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.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 four approved temporary deviation notices (dn) and one nonconformance (nc) 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.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.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.

Event Description

A user facility clinical coordinator (cc) reported that the end cap of the dialyzer was leaking during prime.A certified clinical hemodialysis technician (ccht) discovered the dialyzer leak upon observing normal saline (ns) on the floor.The ccht fell and was injured while attempting to mop the saline.Additional information was obtained through follow-up with the cc.On (b)(6) 2023 during the priming of a hemodialysis (hd) treatment, the dialyzer leaked ns from the end cap.The ccht fell while attempting to mop the fluid.The ccht sought medical attention and it is suspected that they have a broken wrist.The ccht is going to physical therapy three times per week for the injury and has returned to work with a brace and job restrictions (unspecified) in place.The ccht has declined pain medication.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: 18364426
• MDR Text Key: 330996133
• Report Number: 0001713747-2023-00871
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0500318E
• Device Lot Number: 23NU03004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 12/29/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female