MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT DIALYZER, OPTIFLUX ULTRA F180, ASSY; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	0500418E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A hemodialysis (hd) clinic distribution center reported that a blood leak occurred at the cross threaded connection between the bloodlines and the dialyzer immediately after the initiation of hemodialysis (hd) treatment.The blood leak was visually observed as blood reached the dialyzer via the arterial line.The machine, a fresenius 4008 s machine, alarmed appropriately and the patient was using a fresenius dialyzer.Even though no loose connections were found, the leak was due to not being able to securely connect to the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 1 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The nurse stated that when the leak was noticed, the treatment was discontinued and then restarted on a different machine with new supplies.There were no changes during treatment as well as nothing noticed during priming.The nurse confirmed there were no changes or disruption in pressure that could have caused the issue or for the machine to alarm.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Correction: b5.
Event or Problem Description
A hemodialysis (hd) clinic distribution center reported that a blood leak occurred at the cross threaded connection between the bloodlines and the dialyzer immediately after the initiation of hemodialysis (hd) treatment.The blood leak was visually observed as blood reached the dialyzer via the arterial line.The machine, a fresenius 4008 s machine, alarmed for unknown reasons and the patient was using a fresenius dialyzer.Even though no loose connections were found, the leak was due to not being able to securely connect to the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 1 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The nurse stated that when the leak was noticed, the treatment was discontinued and then restarted on a different machine with new supplies.There were no changes during treatment as well as nothing noticed during priming.The nurse confirmed there were no changes or disruption in pressure that could have caused the issue or for the machine to alarm.
Additional Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.During the lot history review it was noted that there were seven other complaints reported against the lot.All seven complaints address external prime leaks from the same clinic.One sample was returned and was confirmed to be pu at the port.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 nc/capa decision tree was completed and the trigger limit has not been exceeded for this lot at this time.Should any future complaints be received on this lot number the decision tree will again be completed in that investigation and an nc/capa initiated as required.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.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.
Event or Problem Description
A hemodialysis (hd) clinic distribution center reported that a blood leak occurred at the cross threaded connection between the bloodlines and the dialyzer immediately after the initiation of hemodialysis (hd) treatment.The blood leak was visually observed as blood reached the dialyzer via the arterial line.The machine, a fresenius 4008 s machine, alarmed for unknown reasons and the patient was using a fresenius dialyzer.Even though no loose connections were found, the leak was due to not being able to securely connect to the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 1 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The nurse stated that when the leak was noticed, the treatment was discontinued and then restarted on a different machine with new supplies.There were no changes during treatment as well as nothing noticed during priming.The nurse confirmed there were no changes or disruption in pressure that could have caused the issue or for the machine to alarm.Upon further follow up, the complaint device is not available to be returned to the manufacturer for physical evaluation.

• Brand Name: DIALYZER, OPTIFLUX ULTRA F180, ASSY
• Common Device Name: 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12861694
• Report Number: 1713747-2021-00436
• Device Sequence Number: 4430205
• Product Code: KDI
• UDI-Device Identifier: 00840861100194
• UDI-Public: 00840861100194
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K123262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: 0500418E
• Device Catalogue Number: 0500318E
• Device Lot Number: 21JU02001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 01/04/2022; 02/08/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 01/04/2022; 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 4008 S MACHINE; FRESENIUS 4008 S MACHINE; FRESENIUS 4008 S MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 52 KG