MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FMC BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number UNKNOWN- FMC BLOODLINE

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

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 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

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.

Manufacturer Narrative

The alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.A device history review was not performed since the lot number of the alleged device is unknown.

Event Description

".".

• Brand Name: FMC BLOODLINE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 7596412
• MDR Text Key: 110910335
• Report Number: 8030665-2018-00898
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN- FMC BLOODLINE
• Device Lot Number: UNKNWON
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: MO
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 06/14/2018; 07/04/2018
• Supplement Dates FDA Received: 06/15/2018; 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008K@ HOME MACHINE; FRESENIUS OPTIFLUX F250NRE DIALYZER; FRESENIUS 2008K@ HOME MACHINE; FRESENIUS OPTIFLUX F250NRE DIALYZER
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 87