MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F250NRE DIALYZER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500325E

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/03/2024

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that an internal dialyzer blood leak occurred at the start of a patient¿s hemodialysis (hd) treatment, approximately three to five minutes after initiation.The blood leak was not visually observed.The machine, a baxter artis, alarmed appropriately with a blood leak alarm.The dialysate was tested with a blood leak test strip, and it tested positive.No physical damage or defects were noted on the dialyzer.The patient¿s blood was not returned.Estimated blood loss (ebl) due to the event was 300 ml.There was no patient injury, adverse event, or medical intervention required due to the event.The patient was able to complete their treatment after being re-setup with new supplies on the same machine.The dialyzer was not available to be returned for manufacturer evaluation as it was reportedly discarded.Photos of the dialyzer were also unavailable.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.Furthermore, a device lot number was not provided and the customer account number is not known.Therefore, a shipping history search could not be performed in sap.As such, a production records review was not performed, and the device history records (dhr) could not be investigated.Based on the information available, a definitive conclusion regarding the complaint incident cannot be reached.

Event Description

It was reported that an internal dialyzer blood leak occurred at the start of a patient¿s hemodialysis (hd) treatment, approximately three to five minutes after initiation.The blood leak was not visually observed.The machine, a baxter artis, alarmed appropriately with a blood leak alarm.The dialysate was tested with a blood leak test strip, and it tested positive.No physical damage or defects were noted on the dialyzer.The patient¿s blood was not returned.Estimated blood loss (ebl) due to the event was 300 ml.There was no patient injury, adverse event, or medical intervention required due to the event.The patient was able to complete their treatment after being re-setup with new supplies on the same machine.The dialyzer was not available to be returned for manufacturer evaluation as it was reportedly discarded.Photos of the dialyzer were also unavailable.

• Brand Name: OPTIFLUX F250NRE DIALYZER
• 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: 19210149
• MDR Text Key: 341382825
• Report Number: 0001713747-2024-00343
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100170
• UDI-Public: 00840861100170
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K162488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0500325E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 109 KG