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

Model Number A015(H6)/ V609(H9)

Device Problems Leak/Splash (1354); Defective Component (2292)

Patient Problem Blood Loss (2597)

Event Date 02/13/2016

Event Type  Injury  

Manufacturer Narrative

Investigation report on retained samples only, pending final investigation on returned sample, in process.(b)(4).

Event Description

After 1 hour and 12 minutes of initiating dialysis treatment, blood leaked from the connection between the venous drip chamber cap and the main tube.Blood was returned to the patient after blood leak was noticed.Patient lost about 100ml of blood.Hct level decreased from 10.3 to 9.4; 3 pieces of 2,000 units each of epo(erythropoietin) was administered to the patient right away.No further information was provided.Other devices used during dialysis treatment: fresenius 4008's dialysis machine; nipro fb-170u dialyzer; nipro avf safetouch 16g needle.

Manufacturer Narrative

Investigation report on retained samples only, pending final investigation on returned sample, in process.

Event Description

After 1 hour and 12 minutes of initiating dialysis treatment, blood leaked from the connection between the venous drip chamber cap and the main tube.Blood was returned to the patient after blood leak was noticed.Patient lost about 100ml of blood.Hct level decreased from 10.3 to 9.4; 3 pieces of 2,000 units each of epo (erythropoietin) was administered to the patient right away.No further information was provided.Other devices used during dialysis treatment: fresenius 4008s dialysis machine, nipro fb-170u dialyzer, nipro avf safetouch 16g needle.

• 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: 5501009
• MDR Text Key: 40346327
• Report Number: 8041145-2016-00010
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: A015(H6)/ V609(H9)
• Device Lot Number: 15E13
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 74