MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500316E

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/18/2024

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¿s biomedical technician (bmt) reported that a visible internal dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment that resulted in a patient safety issue.Follow up with the inpatient services manager (ism), the patient was brought in through the emergency room (er) in respiratory arrest and septic shock (cause unknown).The patient was intubated in the er and transported to the intensive care unit (icu) to begin hemodialysis (hd) and extracorporeal membrane oxygenation (ecmo).The patient received a temporary hd catheter (not a fresenius product), and hd therapy was initiated.Approximately 2.25 hours into treatment, the hd machine¿s blood leak detector began alarming, and blood could be visualized in the dialysate surrounding the dialyzer fibers and within the dialysate loop (hanson connectors).The patients¿ treatment was immediately terminated, and the extracorporeal circuit was discarded (estimated blood loss = 300 ml).The patient did not experience any adverse effects from the blood leak, nor did she require a blood transfusion to replace the lost blood volume.The hd machine was removed from service for disinfection, and the patient¿s treatment was restarted on a new hd machine with a dialyzer and extracorporeal circuit.The remainder of the hd treatment was completed without reported issue.The ism stated the patient¿s current disposition is unknown due to the patient undergoing a single treatment only.Per the ism, the optiflux 160nre dialyzer blood leak was the cause of the patient¿s blood loss.No damage or visual defects were noted on the packaging or product itself.The complaint device was not returned to the manufacturer for evaluation.

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.An investigation of the device history records (dhr) was conducted by the manufacturer.There were multiple 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.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.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¿s biomedical technician (bmt) reported that a visible internal dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment that resulted in a patient safety issue.Follow up with the inpatient services manager (ism), the patient was brought in through the emergency room (er) in respiratory arrest and septic shock (cause unknown).The patient was intubated in the er and transported to the intensive care unit (icu) to begin hemodialysis (hd) and extracorporeal membrane oxygenation (ecmo).The patient received a temporary hd catheter (not a fresenius product), and hd therapy was initiated.Approximately 2.25 hours into treatment, the hd machine¿s blood leak detector began alarming, and blood could be visualized in the dialysate surrounding the dialyzer fibers and within the dialysate loop (hanson connectors).The patients¿ treatment was immediately terminated, and the extracorporeal circuit was discarded (estimated blood loss = 300 ml).The patient did not experience any adverse effects from the blood leak, nor did she require a blood transfusion to replace the lost blood volume.The hd machine was removed from service for disinfection, and the patient¿s treatment was restarted on a new hd machine with a dialyzer and extracorporeal circuit.The remainder of the hd treatment was completed without reported issue.The ism stated the patient¿s current disposition is unknown due to the patient undergoing a single treatment only.Per the ism, the optiflux 160nre dialyzer blood leak was the cause of the patient¿s blood loss.No damage or visual defects were noted on the packaging or product itself.The complaint device was not returned to the manufacturer for evaluation.

• Brand Name: OPTIFLUX 160NRE 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: 19201775
• MDR Text Key: 341433383
• Report Number: 0001713747-2024-00339
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• 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
• Report Date: 04/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 0500316E
• Device Lot Number: 24AU06010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 04/18/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2024
• 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
• Patient Age: 46 YR
• Patient Sex: Female