MAUDE Adverse Event Report: NIPRO (THAILAND) CORP., LTD. NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR; BLOODLINE

Model Number A368TR/V854TR

Device Problems Leak/Splash (1354); Connection Problem (2900); Device Dislodged or Dislocated (2923)

Patient Problems Syncope (1610); Blood Loss (2597)

Event Date 06/21/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation report attached is on retained samples, actual sample is not available, request sent to customer for unused sample from same lot, pending reply from customer.

Event Description

Patient was dialyzing in the acute center of the hospital, after 2 hours into dialysis treatment, nurse noticed blood leak.The bloodline had disconnected from central venous catheter, resulting in 1 liter of blood loss.The patient was unresponsive and sent to the emergency unit of the hospital.Hemoglobin level was at 7.5, 7.9, blood transfusion was administered on (b)(6) 2016 and also on (b)(6) 2016, hemoglobin was at 10.2 on (b)(6) 2016.Patient had right side of body paralyzed after the intervention.Paralysis was found to be less on (b)(6) 2016.Patient was sent to follow up with neurologist.No further information provided.

Manufacturer Narrative

Investigation report attached is on retained samples, actual sample is not available, request sent to customer for unused sample from same lot, pending reply from customer.On 8/4/16: final investigation report attached on retained samples from same lot.

Event Description

Patient was dialyzing in the acute center of the hospital, after 2 hours into dialysis treatment, nurse noticed blood leak.The bloodline had disconnected from central venous catheter, resulting in 1 liter of blood loss.The patient was unresponsive and sent to the emergency unit of the hospital.Hemoglobin level was at 7.5, 7.9, blood transfusion was administered on (b)(6) 2016 and also (b)(6) 2016, hemoglobin was at 10.2 on (b)(6) 2016.Patient had right side of body paralyzed after the intervention.Paralysis was found to be less on (b)(6) 2016.Patient was sent to follow up with neurologist.No further information provided.

Manufacturer Narrative

Investigation report is on retained samples, actual sample is not available, request sent to customer for unused sample from same lot, pending reply from customer.On 8/4/2016: final investigation report attached on retained samples from same lot.On 8/25/2016: factory received unused sample, from same lot number, from the clinic.Additional testing results on investigation report, dated august 17, 2016.

Event Description

Patient was dialyzing in the acute center of the hospital, after 2 hours into dialysis treatment, nurse noticed blood leak.The bloodline had disconnected from central venous catheter, resulting in 1 liter of blood loss.The patient was unresponsive and sent to the emergency unit of the hospital.Hemoglobin level was at 7.5, 7.9, blood transfusion was administered on 6(b)(6) 2016, hemoglobin was at 10.2 on (b)(6) 2016.Patient had right side of body paralyzed after the intervention.Paralysis was found to be less on (b)(6) 2016.Patient was sent to follow up with neurologist.No further information provided.

• Brand Name: NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR
• Type of Device: BLOODLINE
• 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: 5829292
• MDR Text Key: 50646589
• Report Number: 8041145-2016-00016
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: A368TR/V854TR
• Device Lot Number: 16B26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2016
• 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