MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500318E

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A user facility clinic registered nurse (rn) reported a hemodialysis (hd) patient was connected to a 2008t hd machine when the blood leak was noted.The 2008t hd machine generated a blood leak alarm immediately after the hd therapy was initiated.The patient¿s dialysate flow rate (dfr) was 800 and the patient¿s blood flow rate (bfr) was 425.The rn stated the bloodlines used were fresenius.The leak was noted as being an external blood leak and the rn was no longer able to recall the exact location of the reported leak.No visual damage to the bloodline was observed.The patient¿s estimated blood loss (ebl) was confirmed to be approximately 250 ml.The rn stated 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.The rn 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 another machine without further issue.The patient dialyzed 3 times a week.The nurse stated the sample was discarded.

Manufacturer Narrative

Corrected occupation: health care professional.Plant 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 user facility clinic registered nurse (rn) reported a hemodialysis (hd) patient was connected to a 2008t hd machine when the blood leak was noted.The 2008t hd machine generated a blood leak alarm immediately after the hd therapy was initiated.The patient¿s dialysate flow rate (dfr) was 800 and the patient¿s blood flow rate (bfr) was 425.The rn stated the bloodlines used were fresenius.The leak was noted as being an external blood leak and the rn was no longer able to recall the exact location of the reported leak.No visual damage to the bloodline was observed.The patient¿s estimated blood loss (ebl) was confirmed to be approximately 250ml.The rn stated 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.The rn 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 another machine without further issue.The patient dialyzed 3 times a week.The nurse stated the sample was discarded.

• Brand Name: OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
• Type of Device: DIALYZER, 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 Key: 7121254
• MDR Text Key: 95817733
• Report Number: 1713747-2017-00399
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 0500318E
• Device Lot Number: 17NU02001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 01/26/2018
• Supplement Dates FDA Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 95