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 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility hemodialysis clinic manager reported a hemodialysis (hd) patient was connected to a 2008t hd machine when the blood leak was observed.The patient¿s dialysate flow rate (dfr) was 800 and the patient¿s blood flow rate (bfr) was 350.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 200 ml.Per rn the blood was not returned to the patient.The clinic manager 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 clinic manager 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.The patient dialyzed 3 times a week.The clinic manager stated the sample was available for return for evaluation.

Manufacturer Narrative

Plant investigation: the implicated sample was not returned for investigation to date.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 Description

A user facility hemodialysis clinic manager reported a hemodialysis (hd) patient was connected to a 2008t hd machine when the blood leak was observed.The patient¿s dialysate flow rate (dfr) was 800 and the patient¿s blood flow rate (bfr) was 350.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 200ml.Per rn the blood was not returned to the patient.The clinic manager 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 clinic manager 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.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: 7121537
• MDR Text Key: 95817919
• Report Number: 1713747-2017-00400
• 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: 01/24/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 0500316E
• Device Lot Number: 17KU06020
• 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: 01/22/2018
• Supplement Dates FDA Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2017
• 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