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

Model Number 0500318E

Device Problem Fluid/Blood Leak (1250)

Patient Problem Vomiting (2144)

Event Date 08/03/2022

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

At an unknown length of time into a patient¿s hemodialysis (hd) treatment, the patient became sick and started throwing up.The patient¿s blood was returned and their treatment was discontinued.The patient reportedly had a history of experiencing hypotension, so the nurse did not think much of them getting sick.As the dialyzer was being disconnected, blood droplets were observed on the inside of the hansen connector.There was no reported damage found on the dialyzer.Blood test strips were not used to test for blood in the dialysate.However, there was no visible blood in the drain line and the machine did not produce a blood leak alarm.Upon follow-up, it was indicated that the machine failed to alarm appropriately.The patient¿s estimated blood loss (ebl) was minimal ¿ reportedly 3 to 5 ml.Despite the patient getting sick, it was confirmed the patient did not require any medical intervention.The patient was dialyzing on a fresenius 2008t machine and utilizing fresenius bloodlines.The dialyzer that leaked was not available to be returned for evaluation as it was reportedly discarded.Photos of the dialyzer were provided for review.

Manufacturer Narrative

Plant investigation: the reported complaint was confirmed based on the provided photos.The clinic provided two photographs.One photo shows a dialyzer with blood present in the dialyzer fibers, and the lot number of the dialyzer is visible on the device.The second photo shows a close-up view of a dialyzer¿s dialysate port that appears to have been disconnected from the hansen connector.Blood was present on the hansen connector and bloody fluid appears to have dripped onto the dialyzer mounting bracket.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.Continuous improvement is of the utmost importance to fresenius medical care.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.Vision systems and blood leak reduction capas are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.The provided photos did not show an obvious cause for the leak.The potential cause of an internal and external blood leak to occur is an incomplete seal in the potting material.Internal and external leaks may also have separate causes, such as broken fibers or a cracked header cap.The probable causes for damaged/broken fiber(s) or an incomplete seal in the potting material may be manufacturing related and rough handling may cause physical damage to the dialyzer housing and header caps, however, without an examination of the sample it is unknown.As it is unknown what type of leak may have occurred (due to a physical sample not being provided), a probable cause could not be established.

Event Description

At an unknown length of time into a patient¿s hemodialysis (hd) treatment, the patient became sick and started throwing up.The patient¿s blood was returned and their treatment was discontinued.The patient reportedly had a history of experiencing hypotension, so the nurse did not think much of them getting sick.As the dialyzer was being disconnected, blood droplets were observed on the inside of the hansen connector.There was no reported damage found on the dialyzer.Blood test strips were not used to test for blood in the dialysate.However, there was no visible blood in the drain line and the machine did not produce a blood leak alarm.Upon follow-up, it was indicated that the machine failed to alarm appropriately.The patient¿s estimated blood loss (ebl) was minimal ¿ reportedly 3 to 5 ml.Despite the patient getting sick, it was confirmed the patient did not require any medical intervention.The patient was dialyzing on a fresenius 2008t machine and utilizing fresenius bloodlines.The dialyzer that leaked was not available to be returned for evaluation as it was reportedly discarded.Photos of the dialyzer were provided for review.

• 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: 15366816
• MDR Text Key: 305711120
• Report Number: 0001713747-2022-00344
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0500318E
• Device Catalogue Number: 0500318E
• Device Lot Number: 22EU02009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2022
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 63 KG