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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 11/24/2017
Event Type  malfunction  
Manufacturer Narrative
Expiration date: 2020-07-31. Plant investigation: the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed. The entire lot has been sold and distributed. However, an investigation of the device manufacturing records was conducted by the manufacturer. There was no indication of product non-acceptance or deviation in the manufacturing process potentially related to the complaint. This includes non-conformance, rework, labeling, process controls and any other occurrence in production. The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.
 
Event Description
A hemodialysis patient care technician (pct) reported a blood leak upon initiation of a patient's hemodialysis treatment. The patient's blood was not returned and the patient experienced a blood loss of less than 100ml. The dialyzer had been primed following current policy and procedure, and was inspected for evidence of damage prior to use. No kinks were noted in the tubing along the extracorporeal circuit. Additional follow-up with the clinic manager revealed the patient¿s dialysate flow rate (dfr) was 800 and the patient¿s blood flow rate (bfr) was 450. 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 100ml. 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. 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 without issue. The patient dialyzed 3 times a week. The sample was discarded.
 
Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A hemodialysis patient care technician (pct) reported a blood leak upon initiation of a patient's hemodialysis treatment. The patient's blood was not returned and the patient experienced a blood loss of less than 100ml. The dialyzer had been primed following current policy and procedure, and was inspected for evidence of damage prior to use. No kinks were noted in the tubing along the extracorporeal circuit. Additional follow-up with the clinic manager revealed the patient¿s dialysate flow rate (dfr) was 800 and the patient¿s blood flow rate (bfr) was 450. 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 100ml. 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. 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 without issue. The patient dialyzed 3 times a week. The sample was discarded.
 
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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 Key7064691
MDR Text Key251655214
Report Number1713747-2017-00375
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 12/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue Number0500316E
Device Lot Number17JU06031
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 Received12/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/29/2017
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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