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

Model Number 0500316E

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2021

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 reported that a dialyzer blood leak occurred 1 hour, 27 minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an external blood leak.The leak was visually observed from a crack in the venous end head cap.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive.The patient¿s estimated blood loss (ebl) was approximately 350 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on the same machine and treatment completed successfully with new supplies.The complaint dialyzer was reported to be available to be returned to the manufacturer for evaluation.

Event Description

A user facility registered nurse reported that a dialyzer blood leak occurred 1 hour, 27 minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an external blood leak.The leak was visually observed from a crack in the venous end head cap.The machine, a fresenius 2008t machine, did not experience a blood leak alarm during the event.Blood leak test strips were used and tested positive.The patient¿s estimated blood loss (ebl) was approximately 350 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on the same machine and treatment completed successfully with new supplies.The complaint dialyzer was reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Additional information: b5 the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A user facility registered nurse reported that a dialyzer blood leak occurred 1 hour, 27 minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an external blood leak.The leak was visually observed from a crack in the venous end head cap.The machine, a fresenius 2008t machine, did not experience a blood leak alarm during the event.Blood leak test strips were not used.The patient¿s estimated blood loss (ebl) was approximately 350 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on the same machine and treatment completed successfully with new supplies.The complaint dialyzer was reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Additional information: b5 - blood leak test strips were not used the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Manufacturer Narrative

Plant investigation: a sample was returned from the reported lot number for evaluation.During the visual examination of the sample, cracks on the header cap were observed on both ends of the dialyzer.The cracks extended almost all the way around the flange.During the evaluation the top portion of the header cap on one end came completely detached.No other damage or irregularities were noted on the returned sample.It is unknown what may have caused the extensive damage to both header caps.No leak or damage was reported during priming or on the product case.During the lot history review it was noted that there were no other complaints of any kind reported against the lot.A review of the production record was performed.The production record review showed there were two approved temporary deviation notices (dns) in the production of this lot.They are unrelated to the reported complaint event.There was no indication of product non-acceptance or deviation in the manufacturing process related to the complaint event.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production that was potentially related to the complaint.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.There is no recall associated with this complaint.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.

Event Description

A user facility registered nurse reported that a dialyzer blood leak occurred 1 hour, 27 minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an external blood leak.The leak was visually observed from a crack in the venous end head cap.The machine, a fresenius 2008t machine, did not experience a blood leak alarm during the event.Blood leak test strips were not used.The patient¿s estimated blood loss (ebl) was approximately 350 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on the same machine and treatment completed successfully with new supplies.The complaint dialyzer was reported to be available to be 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13081862
• MDR Text Key: 285751887
• Report Number: 1713747-2021-00477
• 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: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0500316E
• Device Catalogue Number: 0500316E
• Device Lot Number: 21LU01007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2021
• 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 2008T MACHINE; FRESENIUS 2008T MACHINE
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 62 KG