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

Catalog Number	0500316E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
Event or Problem Description
A hemodialysis (hd) clinic manager reported during hd treatment the machine alarmed of a blood leak during treatment.Blood was noted coming from the arterial port of the dialyzer into the dialysate.The patient's treatment was terminated without returning the patient's blood.Patient experienced greater than 100 ml of blood loss.Additional follow-up revealed the patient was connected to the 2008t hd machine when the blood leak was observed.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 600 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.Blood was visually noted and a blood leak test strip was not used.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.
Additional Manufacturer Narrative
Brand name: optiflux 160nre dialyzer finished assy.Corrected catalog: 0500316e, udi# (b)(4).A supplemental medwatch report will be submitted upon completion of the investigation.
Event or Problem Description
A hemodialysis (hd) clinic manager reported during hd treatment the machine alarmed of a blood leak during treatment.Blood was noted coming from the arterial port of the dialyzer into the dialysate.The patient's treatment was terminated without returning the patient's blood.Patient experienced greater than 100 ml of blood loss.Additional follow-up revealed the patient was connected to the 2008t hd machine when the blood leak was observed.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 600 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.Blood was visually noted and a blood leak test strip was not used.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.
Additional Manufacturer Narrative
Plant investigation: a production records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.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 production record was reviewed and there was no indication of product non-acceptance or deviation in the manufacturing process potentially related to the complaint.This includes non-conformances, 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 or Problem Description
A hemodialysis (hd) clinic manager reported during hd treatment the machine alarmed of a blood leak during treatment.Blood was noted coming from the arterial port of the dialyzer into the dialysate.The patient's treatment was terminated without returning the patient's blood.Patient experienced greater than 100 ml of blood loss.Additional follow-up revealed the patient was connected to the 2008t hd machine when the blood leak was observed.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 600 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.Blood was visually noted and a blood leak test strip was not used.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.
Additional Manufacturer Narrative
Pma/510(k) #: k002761.
Event or Problem Description
A hemodialysis (hd) clinic manager reported during hd treatment the machine alarmed of a blood leak during treatment.Blood was noted coming from the arterial port of the dialyzer into the dialysate.The patient's treatment was terminated without returning the patient's blood.Patient experienced greater than 100 ml of blood loss.Additional follow-up revealed the patient was connected to the 2008t hd machine when the blood leak was observed.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 600 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.Blood was visually noted and a blood leak test strip was not used.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.

• Brand Name: OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• MDR Report Key: 7041025
• Report Number: 1713747-2017-00363
• Device Sequence Number: 1824204
• Product Code: KDI
• UDI-Device Identifier: 00840861100118
• UDI-Public: 00840861100118
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K002761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 0500316E
• Device Lot Number: 17HU01006
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 11/15/2017; 12/06/2017; 12/06/2017
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 11/20/2017; 12/07/2017; 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1