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

Model Number A372/V858R

Device Problems Connection Problem (2900); Device Operational Issue (2914)

Patient Problem Blood Loss (2597)

Event Date 02/12/2018

Event Type  Injury  

Event Description

At approximately 1:25pm, 30 minutes into dialysis treatment, the nurse was responding to a "venous minimum alarm" on the surdial-x dialysis machine.According to the machine history it was alarming for a minute and a hald, she the nurse noticed the patient was unresponsive.Nurse called emergency assistance and noticed that the patient was covered in blood.It was then noticed that the venous blood line had become disconnected from the venous limb of the central venous catheter.Blood was running out of the lines and the venous limb of the catheter.The nurse said that there was blood from the patient's head all the way down to her feet.The patient was emergently bagged and resuscitated quickly, but due to the amount of air in the lines, the staff was unable to return the patient's blood from the extracorporeal system.The patient received 3 units of blood transfusion overnight due to her hemoglobin being so low (54) port incident.Patient has made a full recovery since the incident.Patient vitals pre-treatment: weight (b)(6) kg, bp 163/117, pulse 93, temp 37.4, blood sugar 8.7 and hgb 72.

Event Description

At approximately 1:25pm, 30 minutes into dialysis treatment, the nurse was responding to a "venous minimum alarm" on the surdial-x dialysis machine.According to the machine history it was alarming for a minute and a hald, she the nurse noticed the patient was unresponsive.Nurse called emergency assistane and noticed that the patient was covered in blood.It was then noticed that the venous blood line had become disconnected from the venous limb of the central venous catheter.Blood was running out of the lines and the venous limb of the catheter.The nurse said that there was blood from the patient's head all the way down to her feet.The patient was emergently bagged and resuscitated quickly, but due to the amount of air in the lines, the staff was unable to return the patient's blood from the extracorporeal system.The patient received 3 units of blood transfusion overnight due to her hemoglobin being so low (54) port incident.Patient has made a full recovery since the incident.Patient vitals pre-treatment: weight 81 kg, bp 163/117, pulse 93, temp 37.4, blood sugar 8.7 and hgb 72.

Manufacturer Narrative

Additional investigation report attached on returned, actual used device.- attachment: [initial investigation report qc180301-301.Pdf, final investigation report (qc180301-301).Pdf].

• Brand Name: NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR
• Type of Device: BLOODLINES
• Manufacturer (Section D): NIPRO (THAILAND) CORP., LTD.; 10/2 moo 8,; bangnomko, sena; ayuthaya, thailand, 13110 ; TH 13110
• MDR Report Key: 7346768
• MDR Text Key: 102711545
• Report Number: 8041145-2018-00014
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A372/V858R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Weight: 81