MAUDE Adverse Event Report: NIPRO THAILAND CORPORATION LTD STANDARD AVF NEEDLE

Model Number 15R20GA15

Device Problems Device Alarm System (1012); Detachment Of Device Component (1104)

Patient Problems Loss of consciousness (2418); Blood Loss (2597)

Event Date 09/29/2012

Event Type  Injury  

Event Description

During hemodialysis treatment, venous needle detached from the right shunt arm of a patient which resulted in approximately 500-1000ml of blood loss.The patient lost consciousness, staff started cardiopulmonary reanimation for 1-2 minutes, patient regained consciousness and was sent to imc unit.(no further information was provided for the date of this incident) on (b)(6) 2012 hemodialysis treatment was performed on a hemodialysis instrument from (b)(4).The instrument issued an alarm at the end of the treatment while ready for patient's disconnection.Apparently no alarm was triggered due to the blood loss.(no further information was provided).

Manufacturer Narrative

Manufacturer investigation report: device not returned to manufacturer.

• Brand Name: STANDARD AVF NEEDLE
• Type of Device: AVF NEEDLE
• Manufacturer (Section D): NIPRO THAILAND CORPORATION LTD; 10/2 moo 8, bangnomko, sena; phra nakhon si; ayutthaya 13110, th ; TH
• Manufacturer (Section G): NIPRO THAILAND CORPORATION LTD; 10/2 moo 8, bangnomko, sena; phra nakhon si; ayutthaya 13110, th ; TH
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 4916525
• MDR Text Key: 6025656
• Report Number: 8041145-2015-00042
• Device Sequence Number: 1
• Product Code: FIE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K955182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15R20GA15
• Device Lot Number: 11C30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2011
• 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 Outcome(s): Hospitalization
• Patient Age: 67 YR