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 10/04/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility clinical manager (cm) reported that an internal dialyzer blood leak occurred with 20 minutes remaining in a patient¿s 3-hour 45-minute hemodialysis (hd) treatment.The blood leak was visually observed in the dialysate (in both the venous hansen line and the drain line).The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.A blood leak test strip was used to test for the presence of blood in the dialysate, and it tested positive.No visible damage was observed on the dialyzer.After the machine alarmed, the patient lines were clamped, the blood pump was stopped, and the patient was disconnected.The patient¿s blood was not returned; estimated blood loss (ebl) was reportedly 250 to 300 ml.The cm confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient did not require any further treatment.The complaint device was reportedly available to be returned for manufacturer evaluation.

Manufacturer Narrative

Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.The corporate provided adapter and blood port caps were returned attached to the dialyzer.There was blood noted throughout the dialyzer and coagulated blood was in the space between the header cap and the polyurethane (pu) cut surface on both ends.The returned sample was subjected to a bubble point leak test.There was no leak detected, possibly due to the coagulated blood.The header caps were removed for further evaluation.A delamination was observed on the pu of the non-cavity id end on the dialyzer extending from approximately 320° to 20°, with the dialysate ports situated at 0°.No other damage or irregularities were noted on the returned 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 one approved temporary deviation notice (dn) 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.The investigation into the complaint was able to confirm the reported event.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 manager (cm) reported that an internal dialyzer blood leak occurred with 20 minutes remaining in a patient¿s 3-hour 45-minute hemodialysis (hd) treatment.The blood leak was visually observed in the dialysate (in both the venous hansen line and the drain line).The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.A blood leak test strip was used to test for the presence of blood in the dialysate, and it tested positive.No visible damage was observed on the dialyzer.After the machine alarmed, the patient lines were clamped, the blood pump was stopped, and the patient was disconnected.The patient¿s blood was not returned; estimated blood loss (ebl) was reportedly 250 to 300 ml.The cm confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient did not require any further treatment.The complaint device was reportedly available to be returned 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: 15628701
• MDR Text Key: 307124044
• Report Number: 0001713747-2022-00429
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• 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: 22KU01012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2022
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 77 KG