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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A hemodialysis (hd) clinic reported to fresenius that a dialyzer blood leak occurred upon initiation of a patient¿s hemodialysis (hd) treatment.There was no patient harm or adverse event reported at intake.The dialyzer was not available to be returned for a manufacturer evaluation.Additional information was requested but was not received to date.

Event Description

A user facility reported that an internal dialyzer blood leak occurred at the start of a patient¿s hemodialysis treatment.It was reported that the blood was observed in the dialysis compartment and outside the membranes of the arterial head.The machine, a fresenius 2008t, did not alarm with a blood leak alert.Blood leak test strips were not used as blood was visually noted with the hansen lines.No further damage and/or defects were noted.Fresenius bloodlines were being utilized for the treatment and the patient¿s blood was not returned.The estimated blood loss (ebl) was reportedly 200 ml.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient was able to complete treatment on a different machine after re-setting up supplies.The dialyzer was reported to be discarded and no longer available for manufacturer evaluation.

Manufacturer Narrative

Additional information: a1, a2, a3, a4, b5, d10, h6 device component code.

Event Description

A user facility reported that an internal dialyzer blood leak occurred at the start of a patient¿s hemodialysis treatment.It was reported that the blood was observed in the dialysis compartment and outside the membranes of the arterial head.The machine, a fresenius 2008t, did the machine alarmed properly for blood leak and treatment was discontinued as soon as the blood leak alarm was observed.Blood leak test strips were not used as blood was visually noted with the hansen lines.No further damage and/or defects were noted.Fresenius bloodlines were being utilized for the treatment and the patient¿s blood was not returned.The estimated blood loss (ebl) was reportedly 200 ml.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient was able to complete treatment on a different machine after re-setting up supplies.The dialyzer was reported to be discarded and no longer available for manufacturer evaluation.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.During the lot history review it was noted that there was one other complaint reported against the lot.The complaint addresses an internal blood leak (no sample).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.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.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 2018-0171 (vision systems) and 2018-0161 (blood leak reduction) are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.

• 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: 14917881
• MDR Text Key: 304004675
• Report Number: 0001713747-2022-00235
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• 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: 22DU02006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2022
• 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; FRESENIUS BLOODLINES; FRESENIUS MACHINE
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 105 KG