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 Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that a patient did not connect the blood line to the dialyzer properly therefore creating a blood leak.The patient¿s estimated blood loss is unknown.Additional information regarding patient outcome/status and demographics have been requested; however, to date none has been received.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

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Event Description

It was reported that a patient did not connect the bloodline to the dialyzer properly therefore creating a blood leak.It is unknown how far long into treatment the blood leak occurred.The patient¿s estimated blood loss is unknown.Additional information received, stated that the leak was external and it was at the connection between the bloodline and the dialyzer.Additionally, the blood was visually observed on the floor.The patient ended up requiring blood transfusion (amount unknown).The patient has a dialysate flow rate (dfr) of 300 and blood flow rate (bfr) of 300.The complaint device is not available to be returned to the manufacturer fro physical evaluation.

Manufacturer Narrative

Additional information:patient identifier,age or date of birth ,sex,, and weight, adverse event or product problem, outcomes attributed to adverse event,event, (concomitant products), (patient code) the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Manufacturer Narrative

Correction: brand name, (catalog number and udi number) clinical investigation: there is a temporal relationship between the patient blood loss and hemodialysis (hd) therapy on the 2008k@home machine, however, the patient reported that he did not properly connect the bloodline to the dialyzer which resulted in a blood leak directly causing the patient blood loss.There is no allegation that the 2008k@home machine malfunctioned or that there was any deficiency in performance.The cause of the blood loss is directly related to the improper connection by the patient the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• 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
• MDR Report Key: 7592655
• MDR Text Key: 110849433
• Report Number: 1713747-2018-00196
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100170
• UDI-Public: 00840861100170
• Combination Product (y/n): N
• PMA/PMN Number: K082414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0500316E
• Device Lot Number: 17EU01015
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008K@ HOME MACHINE; FRESENIUS BLOODLINES
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 87