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

Model Number BL+A223D/V809D

Device Problems Coagulation in Device or Device Ingredient (1096); Occlusion Within Device (1423); Device Operational Issue (2914)

Patient Problems Coagulation Disorder (1779); Hypoglycemia (1912); Blood Loss (2597)

Event Date 04/12/2016

Event Type  Injury  

Manufacturer Narrative

Initial investigation report is based on retained samples only, final investigation on returned samples has not yet been concluded.

Event Description

First day of use of the nipro blood tubing lines, 1 patient clotted: with 36 minutes left of 3.5 hrs treatment, system clotted, wasn't able to return blood and no new set up was started.Patient had tmp alarm prior to clotting.Patient has arterial venous fistula (no known issue), bfr is 400, using revaclear, getting heparin bolus of 1000 units and 400 units/hr maintenance.Patient was sent to the er, per the nurse at the clinic it was due to other reasons, patient was conscious but when the nurse was assessing him, patient wasn't responding, the nurse described that upper extremities were limp(both arms were weak, no strength).Nurse further stated that upon the patient arriving to the clinic, the patient verbalized he wasn't feeling well, and according to the nurse, the patient always states he is not feeling well prior to each dialysis treatment.On (b)(6) 2016: received notes from clinic: because the blood was not returned, clinic amounted the blood loss to 200ml, it is unknown if the patient was given a blood transfusion at the hospital.The last hemoglobin level was 10.6 (done on (b)(6) 2016).Nurse decided to send the patient to the hospital because the patient was unresponsive at the time of assessment.Patient's vitals, prior to being sent to the hospital: blood pressure - 171/91 mmhg, temperature - 97.4 f, pulse - 107.Per the facility nurse, the patient has psychological conditions and the patient was most likely admitted to the psychiatric unit.No further data is available, psychiatric unit will not disclose further information on patient status or outcome.

Manufacturer Narrative

Initial investigation report attached is based on retained samples only, final investigation on returned samples has not yet been concluded.On 4/18/2016: our clinical specialist was in contact with the nurse at the facility and she was advised that the patient was discharged (b)(6) 2016 with a diagnosis of syncope.The patient did not have a blood transfusion.The patient had dialysis at the chronic unit on (b)(6) 2016, no further clotting issues and no further complications were reported.On 5/10/2016: manufacturer final investigation report on returned unused sample.

Event Description

First day of use of the nipro blood tubing lines, 1 patient clotted: with 36 minutes left of 3.5 hrs treatment, system clotted, wasn't able to return blood and no new set up was started.Patient had tmp alarm prior to clotting.Patient has arterial venous fistula (no known issue), bfr is 400, using revaclear, getting heparin bolus of 1000 units and 400 units/hr maintenance.Patient was sent to the er, per the nurse at the clinic it was due to other reasons, patient was conscious but when the nurse was assessing him, patient wasn't responding, the nurse described that upper extremities were limp (both arms were weak, no strength).Nurse further stated that upon the patient arriving to the clinic, the patient verbalized he wasn't feeling well, and according to the nurse the patient always states he is not feeling well prior to each dialysis treatment.On 4/14/2016: received notes from clinic: because the blood was not returned, clinic amounted the blood loss to 200ml, it is unknown if the patient was given a blood transfusion at the hospital.The last hemoglobin level was 10.6 (done on (b)(6) 2016).Nurse decided to send the patient to the hospital because the patient was unresponsive at the time of assessment.Patient's vitals, prior to being sent to the hospital: blood pressure - 171/91 mmhg, temperature - 97.4 f, pulse - 107.Per the facility nurse, the patient has psychological conditions and the patient was most likely admitted to the psychiatric unit.No further data is available, psychiatric unit will not disclose further information on patient status or outcome.

• 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: 5621495
• MDR Text Key: 44120302
• Report Number: 8041145-2016-00012
• 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: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2016,05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: BL+A223D/V809D
• Device Lot Number: 15G08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2016
• Distributor Facility Aware Date: 04/12/2016
• Device Age: 11 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/29/2016
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 04/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2015
• 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): Hospitalization