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

Model Number BL+A217Y/V806

Device Problem Disconnection (1171)

Patient Problems Cardiopulmonary Arrest (1765); Blood Loss (2597); Patient Problem/Medical Problem (2688)

Event Date 01/20/2017

Event Type  Death  

Manufacturer Narrative

Actual used device will not be returned per the clinics protocols.They will send unused sample from same lot.Once received manufacturer will initiate investigation.Actual device not returned per protocols.

Event Description

Patient was on dialysis machine for 2 hours when the venous access became disconnected, bleeding was encountered, cpr initiated , but was unsuccessful, patient deceased.Additional information received 2/7/16: the patient had been a dialysis patient for 30 years and the patient was admitted to the hospital with a possible septic knee.During the course of her stay she had the knee drained and was on prophylactic antibiotics for a possible infection.This was not her first treatment with this catheter.This was a regular dialysis treatment for this patient, as she is a mwf scheduled patient.The patient was being dialyzed in the dialysis room at the facility.She was written for discharge after her dialysis treatment.The nurse stated that the nurse caring for the patient had stepped away for 2-3 minutes and this is when the incident occurred.When the caring nurse returned to the patients bedside, a rapid response was called and then a code blue immediately following that.Nurse stated that the facility is unsure whether the bloodlines became disconnected from the catheter due to patient manipulation of the lines, or if they came off spontaneously.She did say the patient was on the machine for 2 hours prior to this incident with no problems.The nurse was unsure the actual amount of blood loss.The blood flow rate was 400 ml/min, so she guessed it would be around 800-1200 ml's of blood lost.The nurses at the facility take vital signs every 15 min.The last set of vials before the incident was blood pressure- 119/80 and pulse-80 and were taken at 12:55pm.Per the flow sheet, the incident occurred around 1:08pm.Her ultra filtration goal was 3-4 l as tolerated per doctors orders.On (b)(6) 2016: per the death summary in the patients chart it states that the patient suffered cardiopulmonary arrest and was unable to be resuscitated despite full acls protocol.Note: catheter being used at the time was a equistream catheter, lot # rexa0894.Placed (b)(6) 2013 in the right internal jugular via ultrasound.

Manufacturer Narrative

Actual used device will not be returned per the clinics protocols.They will send unused sample from same lot.Once received manufacturer will initiate investigation.On 3/17/17: correction made.Investigation report attached on unused returned samples.

Event Description

Patient was on dialysis machine for 2 hours when the venous access became disconnected, bleeding was encountered, cpr initiated , but was unsuccessful, patient deceased.Additional information received 2/7/16: the patient had been a dialysis patient for 30 years and the patient was admitted to the hospital with a possible septic knee.During the course of her stay, she had the knee drained and was on prophylactic antibiotics for a possible infection.This was not her first treatment with this catheter.This was a regular dialysis treatment for this patient, as she is a mwf scheduled patient.The patient was being dialyzed in the dialysis room at the facility.She was written for discharge after her dialysis treatment.The nurse stated that the nurse caring for the patient had stepped away for 2-3 minutes and this is when the incident occurred.When the caring nurse returned to the patient's bedside, a rapid response was called and then a code blue immediately following that.Nurse stated that the facility is unsure whether the bloodlines became disconnected from the catheter due to patient manipulation of the lines, or if they came off spontaneously.She did say the patient was on the machine for 2 hours prior to this incident with no problems.The nurse was unsure the actual amount of blood loss.The blood flow rate was 400 ml/min, so she guessed it would be around 800-1200 ml's of blood lost.The nurses at the facility take vital signs every 15 min.The last set of vials before the incident was blood pressure- 119/80 and pulse-80 and were taken at 12:55pm.Per the flow sheet, the incident occurred around 1:08pm.Her ultra filtration goal was 3-4 l as tolerated per doctors orders.On 2/8/16: per the death summary in the patient's chart, it states that the patient suffered cardiopulmonary arrest and was unable to be resuscitated despite full acls protocol note: catheter being used at the time was a equistream catheter, lot # rexa0894.Placed on (b)(6) 2013 in the right internal jugular via ultrasound.

• 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
• 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: 6324189
• MDR Text Key: 67205438
• Report Number: 8041145-2017-00003
• 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,Followup
• Report Date: 02/10/2017,03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: BL+A217Y/V806
• Device Lot Number: 15H11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2017
• Distributor Facility Aware Date: 02/03/2017
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2017
• Initial Date Manufacturer Received: 02/07/2017
• Initial Date FDA Received: 02/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2015
• 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): Death
• Patient Age: 50 YR
• Patient Weight: 63