MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500318E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/10/2022

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

A user facility clinic manager (cm) reported they had reinitiated treatment on a hemodialysis (hd) patient due to a clotted venous chamber.It was a new set up with new lines, and new dialyzer.The cm hooked all venous arterial lines to the patient and once arterial blood began pulling the blood leak detector alarmed.Blood test strips were used and tested positive for the presence of blood.Blood was not returned.Upon follow-up, the cm stated the patient had been having issues with their access catheter during treatments on (b)(6) 2022.The cm stated within five minutes after initiation of treatment, blood was observed leaking from within the top fibers of the dialyzer and blood clots were observed in the venous chamber and bloodlines.The cm stated that fresenius bloodlines were used for treatment and confirmed no external blood leak was observed.Per cm the treatment was discontinued and the patient¿s blood was not returned.The same machine was re-setup with a new dialyzer and bloodlines from the same respective lots.Per cm the same issue re-occurred within five minutes after initiation of the second treatment and blood was again observed leaking from within the top fibers of the dialyzer.Per cm treatment was stopped and the patient¿s blood was not returned.The cm stated the estimated blood loss (ebl) was approximately 50 ml from each treatment.The patient was unable to complete hemodialysis treatment on the day of the reported event and per the cm the patient's access catheter was replaced.Per cm following replacement of the access catheter, the patient was able to resume in-center hemodialysis treatment without further issue.Per cm the dialyzers were available to be returned for evaluation.

Event Description

A user facility clinic manager (cm) reported they had reinitiated treatment on a hemodialysis (hd) patient due to a clotted venous chamber.It was a new set up with new lines, and new dialyzer.The cm hooked all venous arterial lines to the patient and once arterial blood began pulling the blood leak detector alarmed.Blood test strips were used and tested positive for the presence of blood.Blood was not returned.Upon follow-up, the cm stated the the patient had been having issues with their access catheter during treatments on (b)(6) 2022.The cm stated within five minutes after initiation of treatment, blood was observed leaking from within the top fibers of the dialyzer and blood clots were observed in the venous chamber and bloodlines.The cm stated that fresenius bloodlines were used for treatment and confirmed no external blood leak was observed.Per cm the treatment was discontinued and the patient¿s blood was not returned.The same machine was re-setup with a new dialyzer and bloodlines from the same respective lots.Per cm the same issue re-occurred within five minutes after initiation of the second treatment and blood was again observed leaking from within the top fibers of the dialyzer.Per cm treatment was stopped and the patient¿s blood was not returned.The cm stated the estimated blood loss (ebl) was approximately 50 ml from each treatment.The patient was unable to complete hemodialysis treatment on the day of the reported event and per the cm the patient's access catheter was replaced.Per cm following replacement of the access catheter, the patient was able to resume in-center hemodialysis treatment without further issue.Per cm the dialyzers were available to be returned for evaluation.

Manufacturer Narrative

Additional information: d9, h3 plant investigation: the reported complaint was not confirmed as the complaint device was not returned to date for manufacturer evaluation.During the lot history review it was noted that there were two other complaints reported against the lot.One complaint is mentioned above and addresses an internal blood leak that was not confirmed with sample evaluation.The other complaint addresses an internal blood leak (no sample).A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.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.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.

• 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: 15678035
• MDR Text Key: 306997726
• Report Number: 0001713747-2022-00461
• Device Sequence Number: 1
• Product Code: KDI
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0500318E
• Device Catalogue Number: 0500318E
• Device Lot Number: 22HU02012
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 85 KG