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  

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.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: d9, h3 plant investigation: a sample from the reported lot number was returned for evaluation.The returned sample was subjected to a laboratory bubble point test.No leaks were detected possibly due to coagulated blood.The dialyzer was then disassembled for further investigation.There were no damages or irregularities noted, however, the sample was returned with blood on the outside of the fibers, specifically a concentration of blood in the bell housing area of the dialyzer.Although no internal leak was noted during testing, the presence of blood on the outside of the fibers indicates that a leak of some type occurred.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.The investigation into the complaint was able to confirm the reported event.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.

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.

• 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: 15678034
• MDR Text Key: 306928933
• Report Number: 0001713747-2022-00460
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

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 Model Number: 0500318E
• Device Catalogue Number: 0500318E
• Device Lot Number: 22HU02012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Device Age: MO
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 12/30/2022
• Supplement Dates FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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