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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 12/20/2017
Event Type  malfunction  
Event Description
A registered nurse (rn) from a user facility reported of a blood leak from the dialyzer. The machine alarmed with blood backed up into the hansen connector. Additional follow-up information received revealed the hd patient was on the machine just a few minutes before major blood leak was noted, and blood reportedly had entered dialyzer and alarm started on machine, blood backed up into hanson hoses, and the machine was stopped. The hd patient was taken off the machine without blood being given back to him and the patient finished treatment on another machine. No problems were noted and no medical attention was required. The biomed was notified and dialysis machine was cleaned per biomed per proctocol. Additional information provided from the rn revealed there were no signs of any defect or damage to the dialyzer or its packaging prior to use, and the blood leak was seen once by staff any myself backing up into the hanson lines. Per rn the dialysis machine did alarm major blood leak alarm at the time, and the blood was noted to go through the hanson and was coming out the drain holes in the wall of the bicarb/acid ports on the wall. The biomedical engineer cleaned machine and blood strips were used per biomed, and the patient's blood flow rate was approximately 300 and the patient's dialysate flow rate was approximately 600. There was approximately 200-250cc blood lost. The sample was available to be returned for evaluation.
 
Manufacturer Narrative
Plant investigation: the complainant facility returned one f180nre dialyzer for manufacturer examination. During the gross visual examination of the sample, a separation was identified within the polyurethane potting near the outer perimeter of the fiber bundle on the cavity id end. The separation extended from approximately 90° to 150° with the dialysate ports at 0°. The separation was within the polyurethane and not a separation of the polyurethane (potting material) and the dialyzer housing (wall). There were no other defects or irregularities visually identified on the fiber bundle or any of the molded dialyzer components. 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 complaint. The lot passed all release criteria. The investigation into the cause of the reported problem was able to confirm the failure mode. There was a confirmed leak on the cavity id end of the dialyzer. The complaint has been deemed confirmed.
 
Event Description
A registered nurse (rn) from a user facility reported of a blood leak from the dialyzer. The machine alarmed with blood backed up into the hansen connector. Additional follow-up information received revealed the hd patient was on the machine just a few minutes before major blood leak was noted, and blood reportedly had entered dialyzer and alarm started on machine, blood backed up into hanson hoses, and the machine was stopped. The hd patient was taken off the machine without blood being given back to him and the patient finished treatment on another machine. No problems were noted and no medical attention was required. The biomed was notified and dialysis machine was cleaned per biomed per protocol. Additional information provided from the rn revealed there were no signs of any defect or damage to the dialyzer or its packaging prior to use, and the blood leak was seen once by staff any myself backing up into the hanson lines. Per rn the dialysis machine did alarm major blood leak alarm at the time, and the blood was noted to go through the hanson and was coming out the drain holes in the wall of the bicarb/acid ports on the wall. The biomedical engineer cleaned machine and blood strips were used per biomed, and the patient's blood flow rate was approximately 300 and the patient's dialysate flow rate was approximately 600. There was approximately 200-250cc blood lost. 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 registered nurse (rn) from a user facility reported of a blood leak from the dialyzer. The machine alarmed with blood backed up into the hansen connector. Additional follow-up information received revealed the hd patient was on the machine just a few minutes before major blood leak was noted, and blood reportedly had entered dialyzer and alarm started on machine, blood backed up into hanson hoses, and the machine was stopped. The hd patient was taken off the machine without blood being given back to him and the patient finished treatment on another machine. No problems were noted and no medical attention was required. The biomed was notified and dialysis machine was cleaned per biomed per proctocol. 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 Key7143556
MDR Text Key248269270
Report Number1713747-2017-00406
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,Followup
Report Date 03/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Catalogue Number0500318E
Device Lot Number17NU01003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received03/15/2018
Was Device Evaluated by Manufacturer? Yes
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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