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

Catalog Number	0500318N
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility certified clinical hemodialysis technician (ccht) reported a dialyzer blood leak occurred during a patient's hemodialysis (hd) treatment.Treatment was discontinued and the patient's blood was not returned.Upon follow-up, the clinic manager (cm) stated immediately after initiation of hd treatment, blood was noticed leaking from a crack in the dialyzer head.Per cm the blood leak was external.The machine, a 2008t, was used and stated the machine did not alarm with a blood leak alert.Blood test strips were used and tested negative for the presence of blood.The patient was utilizing fresenius combi set bloodlines and the patient's blood was not returned.No damage was noted on the dialyzer prior to treatment.Immediately following the event, the patient was re-setup with new supplies on the same machine and completed treatment without issue.The estimated blood loss was 300ml.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 dialyzer was no longer available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility certified clinical hemodialysis technician (ccht) reported a dialyzer blood leak occurred during a patient's hemodialysis (hd) treatment.Treatment was discontinued and the patient's blood was not returned.Upon follow-up, the clinic manager (cm) stated immediately after initiation of hd treatment, blood was noticed leaking from a crack in the dialyzer head.Per cm the blood leak was external.The machine, a 2008t, was used and stated the machine did not alarm with a blood leak alert.Blood test strips were used and tested negative for the presence of blood.The patient was utilizing fresenius combi set bloodlines and the patient's blood was not returned.No damage was noted on the dialyzer prior to treatment.Immediately following the event, the patient was re-setup with new supplies on the same machine and completed treatment without issue.The estimated blood loss was 300ml.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 dialyzer was no longer available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A production records review was performed on the reported lot.During the lot history review it was noted that there were three other complaints reported against the lot.The complaints address three patient's having a reaction to treatment (from the same clinic), which are unrelated to the current event.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.

• Brand Name: OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
• 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 17987123
• Report Number: 0001713747-2023-00726
• Device Sequence Number: 20882674
• Product Code: KDI
• UDI-Device Identifier: 00840861100125
• UDI-Public: 00840861100125
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K002277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 0500318N
• Device Lot Number: 23BU04024
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• 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 2008T MACHINE.; FRESENIUS 2008T MACHINE.; FRESENIUS BLOODLINES.; FRESENIUS BLOODLINES.
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 94 KG