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 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: although it was originally stated that the complaint device was available to be returned to the manufacturer for evaluation, no samples have been received as of this time.Therefore, the reported complaint was not confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A production records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There was one approved temporary deviation notice (dn) noted on the lot, which was unrelated to the reported event.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 complaint.The lot passed all release criteria.A review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.

Event Description

A user facility clinic manager reported that a dialyzer blood leak occurred approximately one hour after initiation of the patient's hemodialysis (hd) treatment.The machine alarmed for blood leak.Blood was not visually observed.Blood test strips were used and positively confirmed the presence of blood.No dialyzer defect or damage was observed.The patient¿s estimated blood loss (ebl) was noted as being approximately 300ml as the patient¿s blood was not returned.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient was given prophylactic antibiotics only.The clinic manager stated that the dialyzers are currently being stored on the floor on a cart and stated that she does not know if people are walking into the cart and dropping them.The complaint device was stated to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Device evaluation: the device was returned to the manufacturer for physical evaluation.A visual examination of the returned device noted that the fiber bundle was wet and revealed the presence blood exposure.Gross visual examination of the returned device did not identify any damage or irregularity to the fiber bundle or any of the molded components.There were no kinked, broken, looped, or damaged fibers on the circumference of the fiber bundle.The polyurethane (pu) material was distributed evenly and was noted to be intact, without any visually identifiable inconsistency.The dialyzer was subjected to a laboratory bubble point test and no leaks were observed.The returned device was also sent for destructive disassembly to better visually examine the pu cut surfaces.The visual examination of the pu cut surfaces noted that both ends were intact and there was no visual damage, irregularities, or separations identified.The fiber bundle was then removed from the dialyzer housing to better inspect the inferior pu surface and fiber bundle.Subsequent visual examination did not identify any damage or irregularities.There were no kinked, looped, or damaged fibers observed.Further visual examination did not identify any voids.The investigation into the cause of the reported problem was not able to confirm the reported leak.The testing of the returned sample could not reveal a probable cause for the customer complaint.Therefore, the complaint is not confirmed.

• 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: 7107841
• MDR Text Key: 95409459
• Report Number: 1713747-2017-00393
• 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: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 0500318E
• Device Lot Number: 17LU02004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2017
• 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: 32 YR
• Patient Weight: 110