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

Model Number BL+A209Y/V803

Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)

Patient Problems Blood Loss (2597); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number unknown, actual used device is to be returned for investigation, still pending.

Event Description

0740am patient care technician noticed blood leak on the blood pump area of the machine.Patient care tech notified the facility administrator, upon inspection noted the tubing on the blood pump had a tear and was leaking blood, staff rinsed back the arterial line, was unable to rinse back venous line due to the leak, patient lost <150cc of blood, staff explained to the patient what had happened, and advised the patient to report any signs and symptoms of anemia, will redraw labs next treatment, new blood lines were set up, and treatment was resumed at 0747am.Blood pressure was within limits, patient denies any complaints.Physician was made aware.Lot number was unknown.

Event Description

0740am patient care technician noticed blood leak on the blood pump area of the machine.Patient care tech notified the facility administrator, upon inspection noted the tubing on the blood pump had a tear and was leaking blood, staff rinsed back the arterial line, was unable to rinse back venous line due to the leak, patient lost <150cc of blood, staff explained to the patient what had happened, and advised the patient to report any signs and symptoms of anemia, will redraw labs next treatment, new blood lines were set up, and treatment was resumed at 0747am.Blood pressure was within limits, patient denies any complaints.Physician was made aware.Lot number was unknown.

Manufacturer Narrative

Lot number unknown, actual used device is to be returned for investigation, still pending.11/19/19: manufacturer investigation report attached is on both retained and returned actual used sample.

Event Description

0740am patient care technician noticed blood leak on the blood pump area of the machine.Patient care tech notified the facility administrator, upon inspection noted the tubing on the blood pump had a tear and was leaking blood, staff rinsed back the arterial line, was unable to rinse back venous line due to the leak, patient lost <150cc of blood, staff explained to the patient what had happened, and advised the patient to report any signs and symptoms of anemia, will redraw labs next treatment, new blood lines were set up, and treatment was resumed at 0747am.Blood pressure was within limits, patient denies any complaints.Physician was made aware.Lot number was unknown.

Manufacturer Narrative

Lot number unknown, actual used device is to be returned for investigation, still pending.11/19/19: manufacturer investigation report atached is on both retained and returned actual used sample.12/02/2020: the initial report inadvertently included the importer report number and was mistakenly labeled as a single mdr report.The patient code (b)(6) in section is a retired code, therefore new codes were added in the "health effect impact code" and "health effect clinical code.".

• 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 13110 ,; TH 13110,
• MDR Report Key: 9226990
• MDR Text Key: 174850367
• Report Number: 8041145-2019-00009
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00383790004053
• UDI-Public: 00383790004053
• Combination Product (y/n): N
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2019,12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL+A209Y/V803
• Device Catalogue Number: BL+A209Y/V803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/23/2019
• Distributor Facility Aware Date: 09/28/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/23/2019
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other