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 Problems Dyspnea (1816); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2022

Event Type  Injury  

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 registered nurse (rn) reported an internal dialyzer blood leak during hemodialysis (hd) treatment.The blood leak strips were used and tested positive.The sample was available to be returned for evaluation.Additional information was requested but was not received to date.

Manufacturer Narrative

Additional information: a1, a2, a3, a4, a5, b1, b2, b5, h6.Concomitant products, h6 health effect - clinical code, h6 health effect impact code.

Event Description

A user facility registered nurse (rn) reported that a dialyzer blood leak occurred approximately 90 minutes after the start of the patient¿s hemodialysis (hd) treatment.It was stated the blood leak was not visually noted and the patient¿s blood was not returned.The facility stated there was no reported blood loss.Upon additional follow-up, the facility confirmed that the machine, a fresenius 2008t machine, alarmed appropriately with blood leak which was resolved two times with adjusting the hansens.Blood leak test strips were used and tested positive for the presence of blood.The director also stated that fresenius bloodlines were used for treatment and confirmed that the leak was internal and no external blood leak was observed.The facility stated that there were no defects or damage seen on the dialyzer.Immediately following the event, the patient was re-setup with new supplies on a different machine where the patient was able to complete treatment.The facility stated the patient was provided oxygen due to shortness of breath.The facility confirmed that there was no patient injury, adverse events, and no other medical intervention required as a result of the reported event.The dialyzer was available to be returned for manufacturer evaluation.

Event Description

A user facility registered nurse (rn) reported that a dialyzer blood leak occurred.Upon additional follow-up, the facility confirmed that the machine, a fresenius 2008t machine, alarmed appropriately with blood leak which was resolved two times with adjusting the hansens.The facility stated the blood leak occurred 90 minutes after the start of the patient¿s hemodialysis (hd) treatment.It was stated the blood leak was not visually noted and the patient¿s blood was not returned.The estimated blood loss (ebl) was 300 ml.Blood leak test strips were used and tested positive for the presence of blood.The director also stated that fresenius bloodlines were used for treatment and confirmed that the leak was internal and no external blood leak was observed.The facility stated that there were no defects or damage seen on the dialyzer.Immediately following the event, the patient was re-setup with new supplies on a different machine where the patient was able to complete treatment.The facility stated the patient was provided oxygen due to shortness of breath.The facility confirmed that there was no patient injury, adverse events, and no other medical intervention required as a result of the reported event.The dialyzer was available to be returned for manufacturer evaluation.

Manufacturer Narrative

Correction: b5, h1 changed from malfunction to serious injury in follow-up 1.

Event Description

A user facility registered nurse (rn) reported that a dialyzer blood leak occurred approximately 90 minutes after the start of the patient¿s hemodialysis (hd) treatment.It was stated the blood leak was not visually noted and the patient¿s blood was not returned.The facility stated there was no reported blood loss.Upon additional follow-up, the facility confirmed that the machine, a fresenius 2008t machine, alarmed appropriately with blood leak which was resolved two times with adjusting the hansens.Blood leak test strips were used and tested positive for the presence of blood.The director also stated that fresenius bloodlines were used for treatment and confirmed that the leak was internal and no external blood leak was observed.The facility stated that there were no defects or damage seen on the dialyzer.Immediately following the event, the patient was re-setup with new supplies on a different machine where the patient was able to complete treatment.The facility stated the patient was provided oxygen due to shortness of breath.The facility confirmed that there was no patient injury, adverse events, and no other medical intervention required as a result of the reported event.The dialyzer was available to be returned for manufacturer evaluation.

Manufacturer Narrative

Additional information: d9, h3 plant investigation: the reported complaint was not confirmed as the complaint device was not returned to date for manufacturer evaluation.During the lot history review it was noted that there were five other complaints reported against the lot.One of the complaints is not associated with the current event.The other four complaints address internal blood leaks (no samples).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 1141369 (blood leak reduction) are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.

Event Description

A user facility registered nurse (rn) reported that a dialyzer blood leak occurred approximately 90 minutes after the start of the patient¿s hemodialysis (hd) treatment.It was stated the blood leak was not visually noted and the patient¿s blood was not returned.The facility stated there was no reported blood loss.Upon additional follow-up, the facility confirmed that the machine, a fresenius 2008t machine, alarmed appropriately with blood leak which was resolved two times with adjusting the hansens.Blood leak test strips were used and tested positive for the presence of blood.The director also stated that fresenius bloodlines were used for treatment and confirmed that the leak was internal and no external blood leak was observed.The facility stated that there were no defects or damage seen on the dialyzer.Immediately following the event, the patient was re-setup with new supplies on a different machine where the patient was able to complete treatment.The facility stated the patient was provided oxygen due to shortness of breath.The facility confirmed that there was no patient injury, adverse events, and no other medical intervention required as a result of the reported event.The dialyzer was available to be returned for manufacturer evaluation.

Manufacturer Narrative

Clinical investigation: there is a temporal relationship between hemodialysis utilizing the optiflux 160nre dialyzer and the patient event of shortness of breath with administration of o2 after an internal blood leak during treatment resulted in 300ml of blood loss to the patient.Additionally, there could be a possible causal or contributory relationship between the blood leak and patient blood loss with subsequent sob and administration of o2 as there was a reported internal blood leak.Although there was no defect or damage observed with the dialyzer, the product evaluation has not been completed.Blood leaks can lead to hypotension, loss of consciousness, and cardiac arrest requiring acute management which includes discontinuation of the hd treatment, oxygen administration, and hemodynamic support.It is unknown if the administration of o2 is considered medical intervention or a standing order at this hd clinic but based on the information provided by the clinic stating that the patient didn¿t require any other medical intervention, it can be concluded that this measure was considered to be medical intervention.Based on the available information, the optiflux 160nre dialyzer cannot be excluded as causing or contributing to the patient¿s adverse event.

• 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: 15984504
• MDR Text Key: 307778080
• Report Number: 0001713747-2022-00609
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0500316E
• Device Catalogue Number: 0500316E
• Device Lot Number: 22NU06009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS HEMODIALYSIS MACHINE
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 57 KG