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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 0500318E
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/15/2017
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: the sample was not returned to date for evaluation. A production records review was performed on the reported lot. An investigation of the device manufacturing records was conducted by the manufacturer. There was no indication of product non-acceptance or deviation during the manufacturing process which could be associated with the reported event. The review included a check of non-conformance, rework, labeling, process controls, and any other occurrence in production potentially related to the reported complaint. The lot passed all release criteria.
 
Event Description
A hemodialysis (hd) patient's clinic registered nurse (rn) reported an hd patient was connected to the 2008t hd machine when the blood leak was observed. The 2008t hd machine generated a blood leak alarm approximately five minute after the hd therapy was initiated. The patient¿s dialysate flow rate (dfr) was 800 and the patient¿s blood flow rate (bfr) was 600. The leak was noted as being an internal blood leak within the dialyzer, and no external leak was noted. No damage to the dialyzer or packaging was observed. The patient¿s estimated blood loss (ebl) was 250ml. The rn stated blood was visually noted and a blood leak test strip was not used after the incident to check for the presence of blood in the dialysate. The rn stated no patient adverse effects were experienced and no medical intervention was required as a result of this event. The patient was able to complete treatment with new supplies on another machine. The patient dialyzed 3 times a week. The sample was available to be returned for evaluation.
 
Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A hemodialysis (hd) patient's clinic registered nurse (rn) reported an hd patient was connected to the 2008t hd machine when the blood leak was observed. The 2008t hd machine generated a blood leak alarm approximately five minute after the hd therapy was initiated. The patient¿s dialysate flow rate (dfr) was 800 and the patient¿s blood flow rate (bfr) was 600. The leak was noted as being an internal blood leak within the dialyzer, and no external leak was noted. No damage to the dialyzer or packaging was observed. The patient¿s estimated blood loss (ebl) was 250ml. The rn stated blood was visually noted and a blood leak test strip was not used after the incident to check for the presence of blood in the dialysate. The rn stated no patient adverse effects were experienced and no medical intervention was required as a result of this event. The patient was able to complete treatment with new supplies on another machine. The patient dialyzed 3 times a week. The sample was available to be returned for evaluation.
 
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Brand NameOPTIFLUX 180NRE DIALYZER FINISHED ASSY.
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 Key7048878
MDR Text Key251515980
Report Number1713747-2017-00370
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100156
UDI-Public00840861100156
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 12/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2020
Device Catalogue Number0500318E
Device Lot Number17KU05019
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 Received12/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/30/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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