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

Catalog Number 0500318E

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 12/16/2023

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 registered nurse (rn) reported to fresenius that a dialyzer blood leak occurred during the patient¿s hemodialysis (hd) treatment.A minor blood leak alarm was received mid-treatment.During additional follow-up with another rn it was reported that the event occurred approximately an hour and a half into treatment and the blood leak could not be visually observed.Blood leak test strips were used and tested positive for the presence of blood.Treatment was discontinued.The patient's blood was not returned.The patient's estimated blood loss (ebl) was not provided.Treatment was restarted on the same machine with new supplies.There was no serious injury or required medical intervention as a result of the reported issue.The patient complained of mild cramping which was relieved upon treatment completion when their blood was returned.The sample is available to be returned to the manufacturer for physical evaluation.

Event Description

A user facility registered nurse (rn) reported to fresenius that a dialyzer blood leak occurred during the patient¿s hemodialysis (hd) treatment.A minor blood leak alarm was received mid-treatment.During additional follow-up with another rn it was reported that the event occurred approximately an hour and a half into treatment and the blood leak could not be visually observed.Blood leak test strips were used and tested positive for the presence of blood.Treatment was discontinued.The patient's blood was not returned.The patient's estimated blood loss (ebl) was not provided.Treatment was restarted on the same machine with new supplies.There was no serious injury or required medical intervention as a result of the reported issue.The patient complained of mild cramping which was relieved upon treatment completion when their blood was returned.The sample is available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: the sample was returned to the manufacturer for physical evaluation.The dialyzer was subjected to a laboratory bubble point test.No leak was detected.The dialyzer was then subjected to destructive disassembly for further visual examination.No damage or irregularities were found.The reported problem was not confirmed as the issue could not be replicated with the returned device.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 notices (dn) reported on the lot which were 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.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.

• Brand Name: OPTIFLUX 180NRE 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: 18355392
• MDR Text Key: 330880130
• Report Number: 0001713747-2023-00866
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

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: 0500318E
• Device Lot Number: 23NU05010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/16/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2023
• 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
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 87 KG