MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR

Model Number BL+A223D/V809D

Device Problems Occlusion Within Device (1423); Decrease in Pressure (1490); Increase in Pressure (1491)

Patient Problem Blood Loss (2597)

Event Date 01/28/2016

Event Type  Injury  

Manufacturer Narrative

Manufacturer investigation results attached on retained samples only.Device not returned to manufacturer.

Event Description

Clinic has experienced clotting issues during treatment, the arterial volume chamber decreasing and the venous chamber volume increasing.The blood tubing system and the patient's hemodialysis catheter clotted.The staff was unable to return the patient's blood.Patient lost the amount of blood in the bloodlines and dialyzers, approx 200 ml of blood.Patient was sent to the hospital to have the hemodialysis catheter exchanged, no further details on the incident.Per the clinic nurse the patient was only on heparin bolus prior to the incident.Facility has started heparin lock during treatment for the hemodialysis catheter.The facility is a re-use/dry-pack facility using both revaclear and revaclear polyflux 21r dialyzers.

• Brand Name: NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR
• Type of Device: BLOOD TUBING SET
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya, ; thailand 13110 ; TH 13110
• Manufacturer (Section G): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya, ; thailand 13110 ; TH 13110
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 5458295
• MDR Text Key: 38960727
• Report Number: 8041145-2016-00005
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/24/2016,02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: BL+A223D/V809D
• Device Lot Number: 15E06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2016
• Distributor Facility Aware Date: 01/29/2016
• Device Age: 9 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/24/2016
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2015
• 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): Required Intervention