MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F250NRE DIALYZER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500325E

Device Problem Obstruction of Flow (2423)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

A hemodialysis (hd) user facility reported to fresenius that they were experiencing many issues with the dialyzer caps provided with the optiflux dialyzers.The staff complained of various issues such as the caps not staying on, the dialyzers clotting, air in the system, and problems draining.No further details were provided at intake.Additional context was provided upon follow-up with the facility¿s clinical manager (cm).The cm confirmed that the staff had been experiencing issues with the dialyzer caps.The cm confirmed that it was not happening for every single treatment, and not every incident had resulted in clotting or blood loss.The cm was unsure how many events there were exactly (with or without blood loss).Per the cm, the ¿new dialyzers¿ only have 2 port caps as opposed to 4, and it has led to much frustration amongst the staff.The cm stated that the main cause of the issues was that the caps were not fitting properly.When the caps were removed from the headers and placed on the dialysate ports (before starting the priming process), the caps were not screwing on.In one scenario, the cm said the caps did not fit at all and the dialyzer had to be discarded.The staff became frustrated by having to ¿waste dialyzers¿.Once they started the priming process, the machine gave an alarm indicating air was in the lines.Eventually they were able to clear the alarms and move into treatment.However, per the cm, the dialyzers were not being primed properly, because of the ill-fitting caps.Once in treatment, blood streaking was seen in the dialyzer, which sometimes led to additional air alarms and eventual clotting.The cm said they¿ve had several patients who had to come off treatment early because of clotting, and some of those patients don¿t normally have clotting issues.On occasion, they would also have draining issues.No further details could be provided, including any patient specific information.However, the cm confirmed there were no adverse events or serious injuries due to the clotting/blood loss incidents.The majority of the time, treatments were able to be completed.No dialyzers (or caps) were available to be returned for evaluation ¿ they were all discarded after use.Following the events, fresenius representatives visited the user facility to gain further insight on the alleged issues.When the representatives asked the nursing staff about the clotting, they stated that during priming all air had been purged properly from the dialyzer and bloodlines prior to initiating treatment.Furthermore, they stated that because the dialyzers are primed and the dialyzer caps removed prior to treatment, the clotting and streaking observed were not directly connected to the dialyzer caps, but because they were using the new caps and the patient didn¿t typically have clotting issues, they associated the two things.The clotting was identified as dialyzer streaking after the blood had been returned to the patient.There was no evidence of clotting during treatment such as increased venous pressure nor visible clots in the chambers or dialyzer headers.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A hemodialysis (hd) user facility reported to fresenius that they were experiencing many issues with the dialyzer caps provided with the optiflux dialyzers.The staff complained of various issues such as the caps not staying on, the dialyzers clotting, air in the system, and problems draining.No further details were provided at intake.Additional context was provided upon follow-up with the facility¿s clinical manager (cm).The cm confirmed that the staff had been experiencing issues with the dialyzer caps.The cm confirmed that it was not happening for every single treatment, and not every incident had resulted in clotting or blood loss.The cm was unsure how many events there were exactly (with or without blood loss).Per the cm, the ¿new dialyzers¿ only have 2 port caps as opposed to 4, and it has led to much frustration amongst the staff.The cm stated that the main cause of the issues was that the caps were not fitting properly.When the caps were removed from the headers and placed on the dialysate ports (before starting the priming process), the caps were not screwing on.In one scenario, the cm said the caps did not fit at all and the dialyzer had to be discarded.The staff became frustrated by having to ¿waste dialyzers¿.Once they started the priming process, the machine gave an alarm indicating air was in the lines.Eventually they were able to clear the alarms and move into treatment.However, per the cm, the dialyzers were not being primed properly, because of the ill-fitting caps.Once in treatment, blood streaking was seen in the dialyzer, which sometimes led to additional air alarms and eventual clotting.The cm said they¿ve had several patients who had to come off treatment early because of clotting, and some of those patients don¿t normally have clotting issues.On occasion, they would also have draining issues.No further details could be provided, including any patient specific information.However, the cm confirmed there were no adverse events or serious injuries due to the clotting/blood loss incidents.The majority of the time, treatments were able to be completed.No dialyzers (or caps) were available to be returned for evaluation ¿ they were all discarded after use.Following the events, fresenius representatives visited the user facility to gain further insight on the alleged issues.When the representatives asked the nursing staff about the clotting, they stated that during priming all air had been purged properly from the dialyzer and bloodlines prior to initiating treatment.Furthermore, they stated that because the dialyzers are primed and the dialyzer caps removed prior to treatment, the clotting and streaking observed were not directly connected to the dialyzer caps, but because they were using the new caps and the patient didn¿t typically have clotting issues, they associated the two things.The clotting was identified as dialyzer streaking after the blood had been returned to the patient.There was no evidence of clotting during treatment such as increased venous pressure nor visible clots in the chambers or dialyzer headers.

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 multiple approved temporary deviation notices (dns) and a non-conformance (nc) reported on the lot.They were all unrelated to the complaint event.There was no indication of product nonacceptance, deviation, nc, 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 based on the limited information provided.Therefore, the complaint is not confirmed.

• Brand Name: OPTIFLUX F250NRE DIALYZER
• 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: 18276934
• MDR Text Key: 330133673
• Report Number: 0001713747-2023-00844
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100170
• UDI-Public: 00840861100170
• 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
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0500325E
• Device Lot Number: 23LU04008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 11/11/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2023
• 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