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

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

The reported complaint is not confirmed as the complaint device was not available for manufacturer evaluation, and the lot number of the suspect device was not provided.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A lot history review was not able to be performed since the lot number was not provided, and neither the patient or clinic name were available.As the lot number was not identified and since no ship history was available, a manufacturing review was not able to be performed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

A user post on the message forum of a dialysis website reported a blood loss event experienced by the poster's spouse.The post revealed that the patient was undergoing a hemodialysis (hd) treatment on a fresenius hd machine when a blood leak was observed from a bloodline connection when the technician pressed "go" to initiate the therapy.The leak was noted as being up near the hd machine.The patient reportedly lost blood on the arterial side only as the blood had not yet circulated into the venous circuit at the time of the incident.The patient's estimated blood loss (ebl) was not provided.When the leak was observed, the technician immediately attached saline-filled syringes to the needle lines, and then primed a new circuit so the patient could receive their full hd treatment.The patient was noted as feeling a little fatigued three days following the event, but doing fine otherwise.No further information has been made available.

• Brand Name: FMC BLOODLINES
• 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6188733
• MDR Text Key: 62854736
• Report Number: 8030665-2016-00630
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: FRESENIUS HEMODIALYSIS MACHINE