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 Obstruction of Flow (2423)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/28/2023

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 clinical manager (cm) reported that a ¿large amount of fibers [within the dialyzer were] not opening or accepting blood which resulted in poor clearance.¿ additional information was provided upon follow-up with the cm as well as the patient care technician (pct) who encountered the issue.The pct said they primed the hemodialysis system (dialyzer and lines) twice, just as they normally do.There were no issues noticed during the priming phase.It was confirmed that the dialyzer was inspected prior to use, and no defects were observed on the device.Approximately two to three minutes into the hemodialysis (hd) treatment, the pct noticed a small strip of red on the fiber bundle, but the rest of the fibers were completely white.The pct stated that blood appeared to be going into the dialyzer without issue, but it didn¿t appear to be coming out (on the venous end).The pct said the color of the fluid exiting the dialyzer was pink, and not red like it should have been.The pct said that it ¿seemed like the fibers weren¿t opening up¿.There were no blood leak or other machine alarms that occurred, and furthermore, no blood was visible in the dialysate.Because there was no blood leak alarm, a blood test strip was not used.Once the pct noticed what was happening, they returned blood to the patient from the arterial side of the circuit, and the treatment was stopped.The machine was removed from service for further evaluation.The patient was moved to a different machine and re-setup with new supplies.The patient was able to complete their treatment without further issue.Blood loss was said to be minimal; the estimated blood loss (ebl) was 25-30 ml.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.No issues were found with the machine that was removed from service.A biomedical technician inspected the machine and confirmed it was functioning correctly.The machine was subsequently returned to service.The dialyzer that was in use was available to be returned for manufacturer evaluation.It was stated that there were no visible defects on the device.

Manufacturer Narrative

Additional information: d9, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.The corporate provided blood port and adapter caps were attached to the returned dialyzer.Blood was noted throughout the device.No damage or irregularities were visually noted on the device.The sample was subjected to a bubble point leak test.No leaks were found and the dialyzer appeared to fill properly with water.The dialyzer was then subjected to destructive disassembly for further visual examination.Upon removal of the header caps, multiple plugged fibers were found on both ends of the dialyzer.No other damage or irregularities were noted.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was then conducted by the manufacturer.There were multiple approved temporary deviation notices (dns) 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.The investigation into the complaint was able to confirm the reported event.The complaint was confirmed due to plugged fibers.The probable causes for this failure to occur are the injection of too much pre-potting polyurethane (pu), too little pre-potting pu, uneven distribution of pu, and a decreased gel time of the pu.All of these can cause the pu to wick into the fiber past the final cut and plug some of the fibers on the peripheral of the cutting surface.These issues are caused during the manufacturing process.

Event Description

A user facility clinical manager (cm) reported that a ¿large amount of fibers [within the dialyzer were] not opening or accepting blood which resulted in poor clearance.¿ additional information was provided upon follow-up with the cm as well as the patient care technician (pct) who encountered the issue.The pct said they primed the hemodialysis system (dialyzer and lines) twice, just as they normally do.There were no issues noticed during the priming phase.It was confirmed that the dialyzer was inspected prior to use, and no defects were observed on the device.Approximately two to three minutes into the hemodialysis (hd) treatment, the pct noticed a small strip of red on the fiber bundle, but the rest of the fibers were completely white.The pct stated that blood appeared to be going into the dialyzer without issue, but it didn't appear to be coming out (on the venous end).The pct said the color of the fluid exiting the dialyzer was pink, and not red like it should have been.The pct said that it ¿seemed like the fibers weren't opening up¿.There were no blood leak or other machine alarms that occurred, and furthermore, no blood was visible in the dialysate.Because there was no blood leak alarm, a blood test strip was not used.Once the pct noticed what was happening, they returned blood to the patient from the arterial side of the circuit, and the treatment was stopped.The machine was removed from service for further evaluation.The patient was moved to a different machine and re-setup with new supplies.The patient was able to complete their treatment without further issue.Blood loss was said to be minimal; the estimated blood loss (ebl) was 25-30 ml.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.No issues were found with the machine that was removed from service.A biomedical technician inspected the machine and confirmed it was functioning correctly.The machine was subsequently returned to service.The dialyzer that was in use was available to be returned for manufacturer evaluation.It was stated that there were no visible defects on the device.

• 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: 18369352
• MDR Text Key: 331334922
• Report Number: 0001713747-2023-00879
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

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: 23KU06030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2023
• 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
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 55 KG