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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 11/17/2017
Event Type  malfunction  
Manufacturer Narrative
Occupation: biomedical engineer plant investigation: the device was returned to the manufacturer for physical evaluation. The complaint sample was received and during visual examination, the investigator noted the cavity id end screw flange was cracked along the threads from approximately 210º to 90º (with the dialysate ports at 0º). There were no witness marks that gave any indication of the cause of the observed damage. 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's, 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 an external leak on the cavity id end of the dialyzer. The complaint has been deemed confirmed.
 
Event Description
A biomedical engineer (biomed tech) reported a hemodialysis (hd) patient the was connected to a 2008t hd machine when the blood leak was observed. The 2008t hd machine generated a blood leak alarm immediately after the hd therapy was initiated. The patient¿s dialysate flow rate (dfr) and blood flow rate (bfr) were unknown. The leak was noted as being an external blood leak at the endcap of the dialyzer, which appeared cracked. No visual damage to the packaging was observed. The patient¿s estimated blood loss (ebl) was approximately 100ml. The biomed tech stated a blood leak test strip was not used after the incident to check for the presence of blood in the dialysate as the blood was visually observed. 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 a new dialyzer on the same machine. The biomed tech stated the machine remained in service without further issue. Per biomed tech 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 biomedical engineer (biomed tech) reported a hemodialysis (hd) patient the was connected to a 2008t hd machine when the blood leak was observed. The 2008t hd machine generated a blood leak alarm immediately after the hd therapy was initiated. The patient¿s dialysate flow rate (dfr) and blood flow rate (bfr) were unknown. The leak was noted as being an external blood leak at the endcap of the dialyzer, which appeared cracked. No visual damage to the packaging was observed. The patient¿s estimated blood loss (ebl) was approximately 100ml. The biomed tech stated a blood leak test strip was not used after the incident to check for the presence of blood in the dialysate as the blood was visually observed. 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 a new dialyzer on the same machine. The biomed tech stated the machine remained in service without further issue. Per biomed tech 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 Key7046148
MDR Text Key123875664
Report Number1713747-2017-00369
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue Number0500318E
Device Lot Number17LU04005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received03/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2017
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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