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 No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility reported that during a patient hemodialysis (hd) treatment the fresenius 2008k2 machine had an unstable transmembrane pressure (tmp).It was reported that the patient was moved to another machine to complete treatment with new supplies.It was also reported that there was blood loss experienced by the patient.However, patient¿s estimated blood loss was unknown.It is unknown if there was any patient adverse event or medical intervention required.Additional information was solicited; however to date none has been received.

Manufacturer Narrative

The sample was not returned to the manufacturer and the lot number was not provided.Since there is no information of product, lot number, patient¿s alternate identifier and clinic; is not possible to obtain any potential lot delivered to the patient in order to retrieve alternate samples from distribution center for evaluation.Lot trend evaluation was not performed since the product and lot number are unknown and there is not information to a possible lot number from product fmc bloodline.No device history review was performed since there is not information of any lot number.

• 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: 7575656
• MDR Text Key: 110345242
• Report Number: 8030665-2018-00870
• 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
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

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 Catalogue Number: UNKNOWN- FMC BLOODLINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 07/27/2018
• Supplement Dates FDA Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008K2 MACHINE