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 10/19/2022

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 user facility biomedical technician (bmt) reported that a blood leak occurred immediately after the start of the patient¿s hemodialysis (hd) treatment.Upon follow-up, the registered nurse (rn) stated the machine, a fresenius 2008t machine, alarmed appropriately with a "minor" blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.The rn also stated that fresenius bloodlines were used for treatment and confirmed that the leak was internal and no external blood leak was observed.The rn stated that there were no defects or damage seen on the dialyzer.Per rn the patient¿s blood was not returned and stated the estimated blood loss was 50 ml.Immediately following the event, the patient was re-setup with new supplies on the same machine where the patient was able to complete treatment.The rn confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The dialyzer was no longer available to be returned for manufacturer evaluation.

Event Description

A user facility biomedical technician (bmt) reported that a blood leak occurred immediately after the start of the patient¿s hemodialysis (hd) treatment.Upon follow-up, the registered nurse (rn) stated the machine, a fresenius 2008t machine, alarmed appropriately with a "minor" blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.The rn also stated that fresenius bloodlines were used for treatment and confirmed that the leak was internal and no external blood leak was observed.The rn stated that there were no defects or damage seen on the dialyzer.Per rn the patient¿s blood was not returned and stated the estimated blood loss was 50 ml.Immediately following the event, the patient was re-setup with new supplies on the same machine where the patient was able to complete treatment.The rn confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The dialyzer was no longer available to be returned for manufacturer evaluation.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.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.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.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.

Event Description

A user facility biomedical technician (bmt) reported that a blood leak occurred immediately after the start of the patient¿s hemodialysis (hd) treatment.Upon follow-up, the registered nurse (rn) stated the machine, a fresenius 2008t machine, alarmed appropriately with a "minor" blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.The rn also stated that fresenius bloodlines were used for treatment and confirmed that the leak was internal and no external blood leak was observed.The rn stated that there were no defects or damage seen on the dialyzer.Per rn the patient¿s blood was not returned and stated the estimated blood loss was 50 ml.Immediately following the event, the patient was re-setup with new supplies on the same machine where the patient was able to complete treatment.The rn confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The dialyzer was no longer available to be returned for manufacturer evaluation.

Manufacturer Narrative

Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During the visual examination of the sample, a potted fiber fragment was observed on the non-cavity id end of the dialyzer.The fiber fragment extended from the potting surface approximately 1.03 mm in length, under magnification (x20), at approximately 180°, with the dialysate ports situated at 0°.An opposing end to the fiber fragment could not be isolated.No other damage or irregularities were noted on the returned sample.During the lot history review it was noted that there was one other complaint reported against the lot.The complaint is the non sample investigation of the current complaint.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.The investigation into the complaint was able to confirm the reported event.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.

• 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: 15676507
• MDR Text Key: 307043723
• Report Number: 0001713747-2022-00459
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0500316E
• Device Catalogue Number: 0500316E
• Device Lot Number: 22KU06018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2022
• 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 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 62 KG