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 06/15/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A clinic manager reported that a dialyzer blood leak occurred during a hemodialysis (hd) treatment.In a follow up the manager clarified that the blood leak occurred in the first 5 minutes of starting the hd treatment.The blood leak was described as being an internal blood leak.The leak was seen visually and was observed toward the top of the dialyzer.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.Fresenius bloodlines were used.The patient¿s estimated blood loss (ebl) was 100ml.There was no patient injury, adverse events or medical intervention required as a result of this event.There was no visible damage seen on the dialyzer prior to treatment.The treatment was completed the same day with new supplies on the same machine.The device is available to be returned to the manufacturer for evaluation.

Event Description

A clinic manager reported that a dialyzer blood leak occurred during a hemodialysis (hd) treatment.In a follow up the manager clarified that the blood leak occurred in the first 5 minutes of starting the hd treatment.The blood leak was described as being an internal blood leak.The leak was seen visually and was observed toward the top of the dialyzer.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.Fresenius bloodlines were used.The patient¿s estimated blood loss (ebl) was 100ml.There was no patient injury, adverse events or medical intervention required as a result of this event.There was no visible damage seen on the dialyzer prior to treatment.The treatment was completed the same day with new supplies on the same machine.The device is available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Additional information: d.9.,h.3.Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.The third party carrier's website was reviewed and it was verified that the fmcna-provided shipping materials were sent to the customer and were subsequently received.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 one 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.

• 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: 14950692
• MDR Text Key: 304007657
• Report Number: 0001713747-2022-00238
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• 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: 22AU06005
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 77 KG