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U.S. Department of Health and Human Services

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

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OGDEN MANUFACTURING PLANT DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 07/01/2017
Event Type  Injury  
Manufacturer Narrative
Plant investigation: the device was not returned to the manufacturer for physical evaluation and the lot number was not provided. Distribution records were reviewed to identify potential lots of this product shipped to the customer for the three (3) month time frame which immediately preceded the event. There were no lot numbers identified that were delivered within this time period. A search was then performed for potential lots that had been distributed to the hospital at the time of the incident and two lots were identified. Batch records for the lots identified were reviewed and confirmed there were no deviations or non-conformance during the manufacturing process. An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements. The product lots involved met all specifications for release. A review of the dhr did not reveal a probable cause for the customer complaint. As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed. Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A registered nurse (rn) at a user facility reported to post market surveillance (pms) that a patient experienced an infection while undergoing hemodialysis (hd) therapy at a hospital. Additional information has been requested, but has not been made available. There was no allegation that a machine, a dialyzer or bloodline malfunction occurred. No parts were available to be returned to the manufacturer for evaluation.
 
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Brand NameDIALYZER
Type of DeviceDIALYZER, 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 Key6784754
MDR Text Key251505155
Report Number1713747-2017-00259
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received11/03/2017
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 Treatment Data
Date Received: 08/10/2017 Patient Sequence Number: 1
Treatment
UNKNOWN BLOODLINES; UNKNOWN HEMODIALYSIS (HD) MACHINE
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