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

Catalog Number UNKNOWN- DIALYZER

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility medical professional reported that a dialyzer blood leak occurred.There was blood in the dialyzer line.The patient was restarted on a new machine.The machine alarmed blood leak.Technical support advised to do a chemical rinse on the machine.Additional information was requested, however it was not available.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As no lot number was provided for this complaint, a search was performed to obtain all lot numbers with the reported catalog number delivered to the patient¿s dialysis unit in the three months prior to the complaint occurrence date.No lots were found to have been delivered in this time period.A production records review was unable to be performed.An investigation of the device history records (dhr) could not be conducted by the manufacturer.It is unknown if the customer receives their product via third party distributor or another purchase method.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.

• Brand Name: 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
• MDR Report Key: 9763353
• MDR Text Key: 181823245
• Report Number: 1713747-2020-00051
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- DIALYZER
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1