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

Model Number DIALYZER

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

Dialysis clinic reported that when rinsing the blood back at the end of treatment a blood leak was observed in the dialyzer.The clinic tested the dialysate at the dialyzer and it tested positive for blood.The dialysis machine did not give a visual or audible alarm.Complainant does not know how long the blood leak was going on before they stopped the dialysate flow.Follow up with the dialysis clinic indicated that there was no medical intervention and the patient did not experience any complications.The dialysis machine was tested and passed all calibration test and remains in service.The dialyzer sample was discarded and the lot number and part number is unknown.

Manufacturer Narrative

The alleged event was not confirmed by the manufacturing plant.The device was not returned to the plant for investigation.The actual device part number and lot number was not provided.A search was performed to obtain all lot numbers delivered to the dialysis unit in the three months prior tot he alleged event.Two lots were identified.A lot history review was performed on both lots.There are no complaints reported against either lot.The production record for both lots was reviewed.One lot had an approved temporary deviation notices and the other lot had two approved temporary deviation notices.They are unrelated to the reported complaint event.There was no indication during the review of the batch records of product non-acceptance or deviation in the manufacturing process potentially related to the complaint.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production.

• Brand Name: DIALYZER
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7147706
• MDR Text Key: 95902575
• Report Number: 1713747-2017-00408
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIALYZER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 01/12/2018
• 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