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 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.

• 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 11380691
• MDR Text Key: 243127320
• Report Number: 1713747-2021-00056
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• 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

• 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
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 03/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/25/2021 Patient Sequence Number: 1