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 10/12/2022

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 biomedical technician (biomed) reported a dialyzer blood leak that occurred during a patient¿s hemodialysis (hd) treatment.Additional information was obtained through follow-up with a patient care technician (pct) familiar with the event.The dialyzer blood leak occurred within three minutes from the initiation of hd treatment.The blood leak was confirmed to be internal, and it was visually observed both in the dialysate compartment of the dialyzer and in the drain line.The machine, a fresenius 2008t machine, alarmed appropriately with a red ¿blood leak¿ alarm.A blood leak test strip was used to test for blood in the dialysate, and it tested positive.While the machine was being primed with saline, it was noted that more saline than usual was drained from the saline bag and air bubbles were noted in the tubing after priming.The machine was primed again to remove air bubbles after the lines were assessed for damage.The dialyzer appeared intact upon visual inspection; no visible damage was observed on the device.Fresenius bloodlines were also being utilized for the treatment.After the machine alarmed, the treatment was paused.The patient¿s blood was not returned; estimated blood loss (ebl) was reportedly 400 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.The patient completed treatment after being resetup with new supplies on a different machine.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.The fibers were returned wet, and blood was noted throughout the dialyzer.During the visual evaluation, a delamination was observed on the polyurethane (pu) of the cavity id end on the dialyzer extending from approximately 310° to 330°, with the dialysate ports situated at 0°.No other damage or irregularities were noted on the returned sample.The sample was not subjected to a laboratory leak test as a delamination is known to affect the integrity of the dialyzer and cause a leak.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 biomedical technician (biomed) reported a dialyzer blood leak that occurred during a patient¿s hemodialysis (hd) treatment.Additional information was obtained through follow-up with a patient care technician (pct) familiar with the event.The dialyzer blood leak occurred within three minutes from the initiation of hd treatment.The blood leak was confirmed to be internal, and it was visually observed both in the dialysate compartment of the dialyzer and in the drain line.The machine, a fresenius 2008t machine, alarmed appropriately with a red ¿blood leak¿ alarm.A blood leak test strip was used to test for blood in the dialysate, and it tested positive.While the machine was being primed with saline, it was noted that more saline than usual was drained from the saline bag and air bubbles were noted in the tubing after priming.The machine was primed again to remove air bubbles after the lines were assessed for damage.The dialyzer appeared intact upon visual inspection; no visible damage was observed on the device.Fresenius bloodlines were also being utilized for the treatment.After the machine alarmed, the treatment was paused.The patient¿s blood was not returned; estimated blood loss (ebl) was reportedly 400 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.The patient completed treatment after being resetup with new supplies on a different machine.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: 15655698
• MDR Text Key: 306893421
• Report Number: 0001713747-2022-00446
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• 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: 10/21/2022
• 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: 22KU01008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2022
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 86 KG