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U.S. Department of Health and Human Services

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

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OGDEN MANUFACTURING PLANT OPTIFLUX DIALYZER ASSEMBLY 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 Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in progress. A supplemental medwatch will be submitted at the completion of these activities. Clinical investigation: a temporal association with the optiflux dialyzer assembly and the reported events of hypotension, dizziness, and shortness of breath (sob) exists. However, based on the lack of available information, potential causality cannot be established. The patient was admitted to the hospital with shortness of breath (sob), non-st segment elevation myocardial infarction (nonstemi), leg wound, diabetes, and fluid overload and a reported drop in blood pressure (bp), dizziness, and sob occurred during the hemodialysis (hd) treatment. The hospital course is unknown. Additional information related to the patient's history, comorbidities, medical records and hospitalization is needed to determine potential causality. Although requested, this information has not been received.
 
Event Description
A facility clinic manager reported a suspected reaction to the crit-line iii blood chamber and/or optiflux dialyzer assembly. The complainant reported that the patient was admitted to the hospital on (b)(6) 2017 with an admission diagnosis of shortness of breath (sob), non-st segment elevation myocardial infarction (nonstemi), leg wound, diabetes, and fluid overload. The patient underwent routine hemodialysis (hd) treatments while hospitalized. This event represents the second of three reported occurrences of hypotension, dizziness, and shortness of breath (sob) that were experienced by the patient while undergoing hemodialysis (hd) therapy. The event date is not known. Shortly after the hd treatment was initiated, the patient became hypotensive, dizzy, and short of breath. The patient was treated with medications (not specified) and completed treatment. Follow-up was provided which revealed that the user facility only used a fresenius crit-line iii blood chamber and an optiflux dialyzer assembly during this hd treatment. The hd machine, bloodline, acid concentrate, and bicarb concentrate were another manufacturer¿s products. The patient has since been discharged home (date unknown). The crit-line iii blood chamber and the optiflux dialyzer assembly were not available to be returned to the manufacturer for evaluation as both was discarded by the user facility.
 
Manufacturer Narrative
The device was not returned to the manufacturer for physical evaluation, and the lot number was not provided. Therefore, the failure mode cannot be confirmed. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device. A manufacturing review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date. This review included the lot numbers for all fresenius dialyzers shipped to this account within the selected time frame. No information was found and no lots were identified during this review, which sought to identify the lot numbers for all bloodline optiflux dialyzers shipped to this account within the selected time frame. As no lot numbers were identified, an expanded search was performed which included the three years prior to event occurrence. One lot number was identified. A records review was performed on the identified lot. An investigation of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event. In addition, the batch record review confirmed the labeling, material, and process controls were within specification. The lot passed all release criteria. A review of the batch production records did not reveal a probable cause for the customer complaint.
 
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Brand NameOPTIFLUX DIALYZER ASSEMBLY
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 Key6546015
MDR Text Key74473182
Report Number1713747-2017-00123
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2017
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 Received05/12/2017
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: 05/04/2017 Patient Sequence Number: 1
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