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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 0500316E
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/18/2017
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: the sample was not returned to date for investigation. 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-conformances, 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 user facility reported a blood leak alarm upon initiation of patient's treatment. The strip tested positive for a blood leak. The dialyzer sample was saved and the machine was pulled after patient's treatment was complete. Follow-up was made with the clinic manager, who stated the hd patient was connected to a 2008t hd machine when the blood leak was observed. The serial number was not provided. The 2008t hd machine generated a blood leak alarm approximately a 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 450. The clinic manager stated the bloodlines used were fresenius. 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 approximately 250ml. The clinic manager stated blood was visually noted and a blood leak test strip was used after the incident to check for the presence of blood in the dialysate; the test strip returned a positive result. Haley 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 the same machine without issue. The patient dialyzed 3 times a week. The clinic manager stated the sample was available for return for evaluation.
 
Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A hemodialysis (hd) patient's user facility reported a blood leak alarm upon initiation of patient's treatment. The strip tested positive for a blood leak. The dialyzer sample was saved and the machine was pulled after patient's treatment was complete. Follow-up was made with the clinic manager, who stated the hd patient was connected to a 2008t hd machine when the blood leak was observed. The serial number was not provided. The 2008t hd machine generated a blood leak alarm approximately a 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 450. The clinic manager stated the bloodlines used were fresenius. 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 approximately 250 ml. The clinic manager stated blood was visually noted and a blood leak test strip was used after the incident to check for the presence of blood in the dialysate; the test strip returned a positive result. (b)(6) 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 the same machine without issue. The patient dialyzed 3 times a week. The clinic manager stated the sample was available for return for evaluation.
 
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Brand NameOPTIFLUX 160NRE 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 Key7088033
MDR Text Key256312338
Report Number1713747-2017-00386
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 01/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Catalogue Number0500316E
Device Lot Number17HU06022
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 Received01/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/20/2017
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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