MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 200NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500320E

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported during a patient's hemodialysis (hd) treatment, a nurse noted blood pooling around the bottom of the dialyzer and dripping to form a puddle on the floor.The machine did not alarm to indicate any leakages.The patient's treatment was paused and blood re-transfused.The patient lost approximately 30 ml of blood; treatment was delayed about 20 minutes while a new circuit was primed, and machine restarted.The nurse took photos of the dialyzer and tubing and bagged up the entire circuit for future reviewed.The entire dialysis circuit was taken by the access rn to be reviewed by her and the nurse manager.Additional information was requested but was not received to date.

Event Description

A user facility reported that an external dialyzer blood leak occurred immediately upon initiation of a patient¿s hemodialysis (hd) treatment.The machine did not alarm with the external blood leak.Visible blood was noted leaking from the venous end casement joint and blood was also pooling around the bottom of the dialyzer and dripping to form a puddle on the floor.A baxter hemodialysis machine and non-fresenius bloodlines were being utilized for the treatment.Blood test strips were not used.No damage was identified on the dialyzer prior to use.The patient's treatment was paused and blood re-transfused.Immediately following the event, treatment was delayed about 20 minutes while a new circuit was primed, and the machine was restarted.The patient was re-setup with new supplies on the same machine where they were able to complete treatment.The patient¿s estimated blood loss (ebl) was 10 ml.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.Photos of the dialyzer leak were provided.The dialyzer was discarded and was no longer available to be returned for a manufacturer evaluation.

Manufacturer Narrative

Plant investigation: the complaint device was not returned to the manufacturer for physical evaluation.Three photographs were provided for the investigation.Photo 1 shows a magnified view of the bottom dialyzer header cap with visible blood outside of the dialyzer pooled on the rim of the header cap and within the threads.Photo 2 is a zoomed out view of the same image and shows blood on the outside of the bloodline tubing and on the floor.Photo 3 is an image of the dialyzer label/lot number.There was no visible damage or cause of the leak noted in any of the photos.During the lot history review it was noted that there were no other complaints on this lot of any type.A review of the production record was performed.There was no indication of product non-acceptance or deviation in the manufacturing process related to the complaint event.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production that was potentially related to the complaint.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.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 2018-0171 (vision systems) and 2018-0161 (blood leak reduction) are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.The investigation into the complaint was able to confirm the reported event.

Event Description

A user facility reported that an external dialyzer blood leak occurred immediately upon initiation of a patient¿s hemodialysis (hd) treatment.The machine did not alarm with the external blood leak.Visible blood was noted leaking from the venous end casement joint and blood was also pooling around the bottom of the dialyzer and dripping to form a puddle on the floor.A baxter hemodialysis machine and non-fresenius bloodlines were being utilized for the treatment.Blood test strips were not used.No damage was identified on the dialyzer prior to use.The patient's treatment was paused and blood re-transfused.Immediately following the event, treatment was delayed about 20 minutes while a new circuit was primed, and the machine was restarted.The patient was re-setup with new supplies on the same machine where they were able to complete treatment.The patient¿s estimated blood loss (ebl) was 10 ml.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.Photos of the dialyzer leak were provided.The dialyzer was discarded and was no longer available to be returned for a manufacturer evaluation.

• Brand Name: OPTIFLUX 200NRE 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: 14490582
• MDR Text Key: 300361786
• Report Number: 0001713747-2022-00176
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100163
• UDI-Public: 00840861100163
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K162488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0500320E
• Device Catalogue Number: 0500320E
• Device Lot Number: 21SU04022
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2021
• 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