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); Inadequate Filtration Process (2308); Device Operational Issue (2914); Filtration Problem (2941)

Patient Problem Coagulation Disorder (1779)

Event Date 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

Pending finalized investigation on returned samples.

Event Description

Blood clot noted on venous line (after venous chamber), filter in venous chamber did not prevent clot from passing through to venous side of bloodline: per field administrator, technician was returning patient's blood after treatment when tech noticed a blood clot on the venous line that passed through the venous chamber filter, tech immediately clamped the line and disconnected the patient.Patient was okay and was discharged home from the clinic with no complaints.(b)(4) 2016: clinical specialist was emailed to request the following information: is this patient with arterial venous fistula or hemodialysis catheter? what kind of heparin was treated (units / direction injection or syringe pump)? treatment condition (qb, qd, time of treatment).Answers: patient's access: avf, heparin: 2000 units bolus and 1000 units/hr infusion, bfr: 400, qd: 600, treatment time: 3hrs 45min (treatment time is prescribed treatment, patient completed the treatment, no blood was lost and patient did not have any reactions).(field administrator and tech were not there (b)(4) 2016 to answer the following: (will be obtained (b)(4) 2016): did tech notice clotting during the treatment? if so, where clotting was found? it seems like arterial and venous are connected in picture, please describe rinse back procedure the technician performed? answers: (b)(6) 2016: patient care technician didn't notice any clotting during the treatment, he only noticed clots on the venous chamber while returning the blood to the patient.For rinse back procedures, patient care technician followed the clinic termination policy: disconnected arterial line from the arterial needle, flushed arterial needle with saline using 10 cc syringe, connected the arterial line to needle-less port and returned blood with a bfr of 200.

Manufacturer Narrative

Pending finalized investigation on returned samples.On 5/25/2016: final investigation attached, results on retained and returned, used & unused samples.

Event Description

Blood clot noted on venous line (after venous chamber), filter in venous chamber did not prevent clot from passing through to venous side of bloodline: per field administrator, technician was returning patient's blood after treatment when tech noticed a blood clot on the venous line that passed through the venous chamber filter, tech immediately clamped the line and disconnected the patient.Patient was okay and was discharged home from the clinic with no complaints.On (b)(6) 2016: clinical specialist was emailed to request the following information: is this patient with arterial venous fistula or hemodialysis catheter? what kind of heparin was treated (units / direction injection or syringe pump)? treatment condition (qb, qd, time of treatment).Answers: patient's access: avf, heparin: 2000 units bolus and 1000 units/hr infusion, bfr: 400, qd: 600, treatment time: 3hrs 45min (treatment time is prescribed treatment, patient completed the treatment, no blood was lost and patient did not have any reactions).(field administrator and tech were not there (b)(6) 2016 to answer the following: (will be obtained (b)(6) 2016): did tech notice clotting during the treatment? if so, where clotting was found? it seems like arterial and venous are connected in picture, please describe rinse back procedure the technician performed? answers: (b)(6) 2016: patient care technician didn't notice any clotting during the treatment, he only noticed clots on the venous chamber while returning the blood to the patient.For rinse back procedures, patient care technician followed the clinic termination policy: disconnected arterial line from the arterial needle, flushed arterial needle with saline using 10 cc syringe, connected the arterial line to needle-less port and returned blood with a bfr of 200.

• 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: 5624252
• MDR Text Key: 44172337
• Report Number: 8041145-2016-00013
• 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: 05/02/2016,05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 04/27/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2016
• Distributor Facility Aware Date: 04/21/2016
• Device Age: 11 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/02/2016
• Date Manufacturer Received: 04/22/2016
• 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): Required Intervention