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 12/22/2021

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 administrator reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The blood went immediately into the venous hansen.The blood was not returned to the patient.Blood was visible in the hansen.The blood leak was noted as being an internal blood leak.The machine, a fresenius 2008k machine, alarmed appropriately with a blood leak alarm.The test strips were not used because the blood was visually seen.The patient¿s estimated blood loss (ebl) was approximately 200 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Event Description

A user facility administrator reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The blood went immediately into the venous hansen.The blood was not returned to the patient.Blood was visible in the hansen.The blood leak was noted as being an internal blood leak.The machine, a fresenius 2008k machine, alarmed appropriately with a blood leak alarm.The test strips were not used because the blood was visually seen.The patient¿s estimated blood loss (ebl) was approximately 200 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Plant investigation: the investigation into the complaint was able to confirm the reported event.The complaint device was returned to the manufacturer for physical evaluation.The returned sample was subjected to a laboratory bubble point test.The dialyzer failed; a steady stream of bubbles were coming from the cut surface at approximately 150° on the cavity id end, with the ports positioned at 0°.Upon extraction of the fiber bundle, a fiber fragment was noted from the same area as the leak.Under magnification (x20) the fiber fragment was found to be flush with the potting surface, an opposing end could not be isolated.There was no other damage or irregularities visually noted on the dialyzer.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 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.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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13119990
• MDR Text Key: 285828793
• Report Number: 1713747-2021-00479
• 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: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

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 Model Number: 0500316E
• Device Catalogue Number: 0500316E
• Device Lot Number: 21NU01006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Device Age: MO
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 02/16/2022
• Supplement Dates FDA Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2021
• 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 2008K MACHINE; FRESENIUS 2008K MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 72 KG