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 Problems Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2022

Event Type  Injury  

Event Description

A hemodialysis (hd) clinic reported to fresenius that a dialyzer blood leak occurred upon initiation of a patient¿s hemodialysis (hd) treatment.The clinical nurse (cn) reported the optiflux 180nre dialyzer had a crack on the cap of the venous side of the dialyzer.There was no patient harm or adverse event reported at intake.It was unknown if the patient¿s blood was returned.The estimated blood loss (ebl) was unknown.The patient completed their treatment after being re-setup with new supplies on a different machine.The dialyzer was available to be returned for manufacturer evaluation.Additional information was requested but was not received to date.

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 an external dialyzer blood leak occurred one hour after initiation of a patient¿s hemodialysis (hd) treatment.The charge nurse (cn) reported the optiflux 180nre dialyzer had a blood leak on the venous connection side of the dialyzer around the larger cap that actually connects to the dialyzer.The machine, a fresenius 2008t, did not alarm with a blood leak alert as the staff visually noted blood leaking onto the floor from around the rim of the dialyzer cap on the venous side and discontinued treatment.Fresenius bloodlines were being utilized for the treatment.Blood test strips were not used.The patient¿s blood was not returned.It was reported the patient was hypotensive the last 20 minutes of treatment and was relieved with 100ml normal saline and a decrease of the ultrafiltration rate to the minimum setting.The estimated blood loss (ebl) was 300 ml.The patient completed their treatment after being re-setup with new supplies on the same machine.The dialyzer was available to be returned for manufacturer evaluation.

Manufacturer Narrative

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

Manufacturer Narrative

Plant investigation: a sample from the reported lot number was returned for evaluation.There was no damage or irregularities noted on the sample.During a laboratory leak test, no external leak was detected on the 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 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.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.

Event Description

A hemodialysis (hd) clinic reported to fresenius that an external dialyzer blood leak occurred one hour after initiation of a patient¿s hemodialysis (hd) treatment.The charge nurse (cn) reported the optiflux 180nre dialyzer had a blood leak on the venous connection side of the dialyzer around the larger cap that actually connects to the dialyzer.The machine, a fresenius 2008t, did not alarm with a blood leak alert as the staff visually noted blood leaking onto the floor from around the rim of the dialyzer cap on the venous side and discontinued treatment.Fresenius bloodlines were being utilized for the treatment.Blood test strips were not used.The patient¿s blood was not returned.It was reported the patient was hypotensive the last 20 minutes of treatment and was relieved with 100ml normal saline and a decrease of the ultrafiltration rate to the minimum setting.The estimated blood loss (ebl) was 300 ml.The patient completed their treatment after being re-setup with new supplies on the same machine.The dialyzer was available to be returned for manufacturer evaluation.

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hd therapy utilizing an optiflux 180nre dialyzer, and the serious adverse events of blood loss (approximately 300 ml) and intradialytic hypotension, as the patient was actively undergoing hd therapy when the events occurred.Per the cn, the patient¿s blood was visualized externally on the floor, therefore a blood leak test strip was not required.No visible damage was noted on the exterior of the dialyzer; however, it was apparent to staff the blood was leaking from the optiflux 180nre.Intradialytic hypotension is the most prevalent complication associated with hd and occurs in approximately 25% of all treatments.Very often, the cause of intradialytic hypotension is multifactorial.Based on the totality of the information available, the optiflux 180nre dialyzer cannot be excluded from having a possible causal role in the patient¿s blood loss and hypotension events.Testimony from the cn indicated a fresenius product(s) defect and/or malfunction occurred precipitating the blood loss and hypotensive events.If the optiflux 180nre dialyzer is returned, a manufacturer evaluation may dissociate the dialyzer from having caused the serious adverse events.However, without a product evaluation and treatment records, this clinical investigation cannot disassociate the product from the serious adverse events.

Event Description

A hemodialysis (hd) clinic reported to fresenius that an external dialyzer blood leak occurred one hour after initiation of a patient¿s hemodialysis (hd) treatment.The charge nurse (cn) reported the optiflux 180nre dialyzer had a blood leak on the venous connection side of the dialyzer around the larger cap that actually connects to the dialyzer.The machine, a fresenius 2008t, did not alarm with a blood leak alert as the staff visually noted blood leaking onto the floor from around the rim of the dialyzer cap on the venous side and discontinued treatment.Fresenius bloodlines were being utilized for the treatment.Blood test strips were not used.The patient¿s blood was not returned.It was reported the patient was hypotensive the last 20 minutes of treatment and was relieved with 100ml normal saline and a decrease of the ultrafiltration rate to the minimum setting.The estimated blood loss (ebl) was 300 ml.The patient completed their treatment after being re-setup with new supplies on the same machine.The dialyzer was available to be returned for manufacturer evaluation.

Manufacturer Narrative

Correction: b6, h1 type of reportable event.

Event Description

A hemodialysis (hd) clinic reported to fresenius that an external dialyzer blood leak occurred one hour after initiation of a patient¿s hemodialysis (hd) treatment.The charge nurse (cn) reported the optiflux 180nre dialyzer had a blood leak on the venous connection side of the dialyzer around the larger cap that actually connects to the dialyzer.The machine, a fresenius 2008t, did not alarm with a blood leak alert as the staff visually noted blood leaking onto the floor from around the rim of the dialyzer cap on the venous side and discontinued treatment.Fresenius bloodlines were being utilized for the treatment.Blood test strips were not used.The patient¿s blood was not returned.It was reported the patient was hypotensive the last 20 minutes of treatment and was relieved with 100ml normal saline and a decrease of the ultrafiltration rate to the minimum setting.The estimated blood loss (ebl) was 300 ml.The patient completed their treatment after being re-setup with new supplies on the same machine.The dialyzer was available to be returned for manufacturer evaluation.

• 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: 14959453
• MDR Text Key: 304356288
• Report Number: 0001713747-2022-00240
• 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,Followup,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0500318E
• Device Catalogue Number: 0500318E
• Device Lot Number: 22CU05005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2022
• 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: 90 YR
• Patient Sex: Female
• Patient Weight: 57 KG