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

Model Number NS-3041-12

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problems Anemia (1706); Blood Loss (2597)

Event Date 03/12/2018

Event Type  malfunction  

Event Description

Sixty minutes after initiation of dialysis treatment, blood leakage occurred from the connection to the heparin.A crack was found and confirmed on the connector where the leakage occurred.Since the patient already has anemia, a 300ml of blood transfusion was given to the patient due to 250ml of blood loss.Conditions at the time of incident: 200ml/min blood flow rate, 500ml/min dialysate flow rate, 1000ml of normal saline used during priming.

Event Description

60 minutes after initiation of dialysis treatment, blood leakage occurred from the connection to the heparin.A crack was found and confirmed on the connector where the leakage occurred.Since the patient already has anemia, a 300ml of blood transfusion was given to the patient due to 250ml of blood loss.Conditions at the time of incident: 200ml/min blood flow rate, 500ml/min dialysate flow rate, 1000ml of normal saline used during priming.

Manufacturer Narrative

- attachment: [investigation report (b)(4).

• Brand Name: NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR
• Type of Device: BLOODLINE
• Manufacturer (Section D): NIPRO (THAILAND) CORP., LTD.; 10/2 moo 8,; bangnomko, sena; ayuthaya, thailand, 13110 ; TH 13110
• MDR Report Key: 7383697
• MDR Text Key: 104044700
• Report Number: 8041145-2018-00015
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: NS-3041-12
• Device Catalogue Number: 73640
• Device Lot Number: 17J20
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 03/12/2018
• Supplement Dates FDA Received: 04/26/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention