MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT F3 DIALYZER FINISHED ASSY; DIALYZER, CAPILLARY, HOLLOW FIBER

Model Number	0520165A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
It was reported to fresenius customer service that a dialyzer blood leak occurred during the patient's hemodialysis (hd) treatment.Blood was visually observed on the floor (at 16:25) between the gambro phoenix (non-fresenius) machine and the chair.The clinical team observed a leak coming from the venous side of the f3 dialyzer.A crack was identified on the head of the dialyzer.Treatment was paused.The patient¿s blood could not be returned.The patient¿s estimated blood loss (ebl) could not be determined by the clinical team.The patient did not complete treatment on the day of the event.Prophylactic antibiotics were administered to the patient as a risk of contamination was perceived with the external dialyzer leak.The patient¿s hemoglobin & hematocrit (h&h) were taken and the patient¿s vitals were found to be stable.The patient returned to the clinic three days later on (b)(6) 2023 for a follow-up visit.The patient's h&h was taken again and it was determined that a transfusion was not required.The sample is available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: a sample from the reported lot number was returned for evaluation.During gross visual examination, a pinched o-ring on the non-cavity id end was identified.The header cap on the non-cavity id was removed for further evaluation.It was noted that the o-ring was pinched at approximately 210°.Upon removal of the o-ring, the polyurethane (pu) was noted to be damaged due to the pinched o-ring.The pu had been compressed where the o-ring was pinched.There was no other damaged (no crack noted on header cap) or irregularities noted on the returned sample.The manufacturing production record for the reported lot was reviewed.There was no indication of product non-acceptance or deviation in the manufacturing process potentially related to the complaint.This includes non-conformances, rework, labeling, process controls and any other occurrence in production.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.There is no recall associated with this complaint.The manufacturer was able to confirm the reported problem.A pinched o-ring may occur when the o-ring is not properly seated, as dialyzer manufacturing personnel manually place the o-ring beneath the header cap during the assembly process of this dialyzer.
Event or Problem Description
It was reported to fresenius customer service that a dialyzer blood leak occurred during the patient's hemodialysis (hd) treatment.Blood was visually observed on the floor (at 16:25) between the gambro phoenix (non-fresenius) machine and the chair.The clinical team observed a leak coming from the venous side of the f3 dialyzer.A crack was identified on the head of the dialyzer.Treatment was paused.The patient¿s blood could not be returned.The patient¿s estimated blood loss (ebl) could not be determined by the clinical team.The patient did not complete treatment on the day of the event.Prophylactic antibiotics were administered to the patient as a risk of contamination was perceived with the external dialyzer leak.The patient¿s hemoglobin & hematocrit (h&h) were taken and the patient¿s vitals were found to be stable.The patient returned to the clinic three days later on 4/13/2023 for a follow-up visit.The patient's h&h was taken again and it was determined that a transfusion was not required.The sample is available to be returned to the manufacturer for physical evaluation.
Event or Problem Description
It was reported to fresenius customer service that a dialyzer blood leak occurred during the patient's hemodialysis (hd) treatment.Blood was visually observed on the floor (at 16:25) between the gambro phoenix (non-fresenius) machine and the chair.The clinical team observed a leak coming from the venous side of the f3 dialyzer.A crack was identified on the head of the dialyzer.Treatment was paused.The patient¿s blood could not be returned.The patient¿s estimated blood loss (ebl) could not be determined by the clinical team.The patient did not complete treatment on the day of the event.Prophylactic antibiotics were administered to the patient as a risk of contamination was perceived with the external dialyzer leak.The patient¿s hemoglobin & hematocrit (h&h) were taken and the patient¿s vitals were found to be stable.The patient returned to the clinic three days later on 4/13/2023 for a follow-up visit.The patient's h&h was taken again and it was determined that a transfusion was not required.The sample is available to be returned to the manufacturer for physical evaluation.

• Brand Name: F3 DIALYZER FINISHED ASSY
• Common Device Name: DIALYZER, CAPILLARY, HOLLOW FIBER
• 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: 16777940
• Report Number: 0001713747-2023-00271
• Device Sequence Number: 6987305
• Product Code: FJI
• UDI-Device Identifier: 00840861100019
• UDI-Public: 00840861100019
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K874872
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2023

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: 03/31/2025
• Device Model Number: 0520165A
• Device Catalogue Number: 0520165A
• Device Lot Number: 22CU04017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 05/31/2023; 06/02/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 06/01/2023; 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 14 KG