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

Catalog Number 0500316E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A hemodialysis (hd) patient's user facility reported a blood leak alarm upon initiation of patient's treatment.The strip tested positive for a blood leak.The dialyzer sample was saved and the machine was pulled after patient's treatment was complete.Follow-up was made with the clinic manager, who stated the hd patient was connected to a 2008t hd machine when the blood leak was observed.The serial number was not provided.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 800 and the patient¿s blood flow rate (bfr) was 450.The clinic manager stated the bloodlines used were fresenius.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 250 ml.The clinic manager stated 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.(b)(6) 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 the same machine without issue.The patient dialyzed 3 times a week.The clinic manager stated the sample was available for return for evaluation.

Manufacturer Narrative

Plant investigation: the sample was not returned to date for 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 hemodialysis (hd) patient's user facility reported a blood leak alarm upon initiation of patient's treatment.The strip tested positive for a blood leak.The dialyzer sample was saved and the machine was pulled after patient's treatment was complete.Follow-up was made with the clinic manager, who stated the hd patient was connected to a 2008t hd machine when the blood leak was observed.The serial number was not provided.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 800 and the patient¿s blood flow rate (bfr) was 450.The clinic manager stated the bloodlines used were fresenius.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 250ml.The clinic manager stated 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.Haley 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 the same machine without issue.The patient dialyzed 3 times a week.The clinic manager stated the sample was available for return for evaluation.

• Brand Name: OPTIFLUX 160NRE 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: 7088033
• MDR Text Key: 94941127
• Report Number: 1713747-2017-00386
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• 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: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 0500316E
• Device Lot Number: 17HU06022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2017
• 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