MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT F4 DIALYZER PRODUCTION ASSY.; DIALYZER, CAPILLARY, HOLLOW FIBER

Model Number	0520161A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/25/2020
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
A user facility patient care manager reported that an external dialyzer blood leak occurred forty-five minutes into a patient¿s hemodialysis (hd) treatment.The blood leak was reported to be coming from a crack that was identified in the header of the dialyzer.Nothing unusual was noted during priming or setup.The machine, a gambro phoenix, did not alarm.Fresenius bloodlines were not used for the treatment; a gambro cartridge blood set was in use at the time of the event.Blood leak test strips were used, and they tested negative for blood from the dialyzer ports.After identifying the blood leak, treatment was paused.The patient¿s estimated blood loss (ebl) was approximately 117 ml.The patient care manager stated there was no harm to the patient during or after the incident.It was also confirmed that no medical intervention was required as a result of the reported event.The patient was able to complete treatment after being re-setup with new supplies on the same machine.The dialyzer was not available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
Additional information: a2, a3 plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.The customer provided three pictures of a used dialyzer.Blood was visually present on the exterior surface of the dialyzer housing on the label and around the lower header cap.However, no crack was visible in the pictures.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.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.

• Brand Name: F4 DIALYZER PRODUCTION ASSY.
• Common Device Name: DIALYZER, CAPILLARY, HOLLOW FIBER
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• MDR Report Key: 9836562
• Report Number: 1713747-2020-00072
• Device Sequence Number: 11522408
• Product Code: FJI
• UDI-Device Identifier: 00840861100026
• UDI-Public: 00840861100026
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K874872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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: 04/30/2022
• Device Model Number: 0520161A
• Device Catalogue Number: 0520161A
• Device Lot Number: 19DU04012
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 16