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

Model Number BL+A209Y/V803

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problem Blood Loss (2597)

Event Date 09/25/2019

Event Type  malfunction  

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.

• 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: 9226896
• MDR Text Key: 178729234
• Report Number: 1056186-2019-00012
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00383790004053
• UDI-Public: 00383790004053
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2019

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other