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 Itching Sensation (1943)

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between a blood leak occurring with the fresenius optiflux 160nre dialyzer during this patient¿s hd treatment and subsequent blood loss (approximately 250cc) with associated itching which was resolved via treatment with intravenous (iv) benadryl on an outpatient basis.However, a causal relationship could not be determined.The patient was able to complete their regularly scheduled hd treatment without any further adverse events/hospitalization.The optiflux dialyzer manufacturer instructions for use cautions that blood leaks can occur during treatment which can lead to patient blood loss.Therefore, a causal/contributory relation cannot be excluded.Currently, there is no allegation of any visual defects or product deficiency with the fresenius optiflux 160nre dialyzer that led to the reported blood leak.Reportedly, the patient has since continued their regularly scheduled hd therapy with the same brand dialyzer without any further issues or complaints of itching.

Event Description

A user facility biomedical technician (biomed) reported to fresenius customer service that a dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment and that the patient complained of itching.Additional information was obtained through follow-up with the facility¿s clinical manager (cm).The dialyzer used for the treatment was reportedly primed, per clinic protocol.There were no visual defects noted on the device prior to use.After treatment began (time not specified), the dialysis machine alarmed with a blood leak alert and blood was visible in the dialysate line (as expected).The patient¿s hd treatment was discontinued temporarily.The patient¿s blood was not rinsed back, per clinic protocol.Therefore, the patient lost approximately 250 cc of blood.The patient¿s vitals remained normal and the patient did not have any serious injuries due to the reported blood loss.However, the patient did complain of itching near the scapula area, stomach, and legs post-incident.As a result, the patient¿s nephrologist ordered benadryl intravenously which resolved the patient¿s itch.The patient completed their treatment with a new dialysis set up, without any harm incurred.The patient did not require hospitalization.The patient has continued their regularly scheduled hd therapy with the same brand dialyzer without any further issues or complaints (including itching).The dialyzer was reported to be available for manufacturer evaluation.

Manufacturer Narrative

Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.The corporate provided blood port caps and adapter caps were returned attached to the dialyzer.There was blood noted throughout the dialyzer and in both head caps.There was no damage noted on the returned sample.A laboratory bubble point leak test was performed on the returned sample.A leak was detected on the cavity id end at 0° with the ports situated at 0°.The dialyzer was then subjected to destructive disassembly for further visual examination.A delamination was identified at approximately 290° to 45° on the cavity id end, with the dialysate ports positioned at 0°.Further examination of the complaint device did not identify any other damage or irregularities.The source of the dialyzer leak was observed and confirmed.No irregularity or cause related to the report of itching was noted.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was then 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.The investigation into the complaint was able to confirm the reported event.

Event Description

A user facility biomedical technician (biomed) reported to fresenius customer service that a dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment and that the patient complained of itching.Additional information was obtained through follow-up with the facility¿s clinical manager (cm).The dialyzer used for the treatment was reportedly primed, per clinic protocol.There were no visual defects noted on the device prior to use.After treatment began (time not specified), the dialysis machine alarmed with a blood leak alert and blood was visible in the dialysate line (as expected).The patient¿s hd treatment was discontinued temporarily.The patient¿s blood was not rinsed back, per clinic protocol.Therefore, the patient lost approximately 250 cc of blood.The patient¿s vitals remained normal and the patient did not have any serious injuries due to the reported blood loss.However, the patient did complain of itching near the scapula area, stomach, and legs post-incident.As a result, the patient¿s nephrologist ordered benadryl intravenously which resolved the patient¿s itch.The patient completed their treatment with a new dialysis set up, without any harm incurred.The patient did not require hospitalization.The patient has continued their regularly scheduled hd therapy with the same brand dialyzer without any further issues or complaints (including itching).The dialyzer was reported to be available for manufacturer evaluation.

• 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
• MDR Report Key: 11380691
• MDR Text Key: 243127320
• Report Number: 1713747-2021-00056
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• Combination Product (y/n): N
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 0500316E
• Device Catalogue Number: 0500316E
• Device Lot Number: 20NU06021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Device Age: MO
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR