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

Model Number A372R-V858R-GT

Device Problems Unintended Ejection (1234); Connection Problem (2900)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 06/12/2020

Event Type  Death  

Event Description

Approximately 10 minutes into a 3.5hour treatment, the machine alarmed for low arterial pressure.The blood pump was stopped and the lines are reversed to improve arterial pressures and blood flow.Within 2 minutes, the patient's condition deteriorated.Upon examination, staff noticed the venous line was disconnected, fluid resuscitation attempted without success.Patient deceased.Actual lot number is unknown.Possible lot number is 19l20.

Event Description

Approximately 10 minutes into a 3.5hour treatment, the machine alarmed for low arterial pressure.The blood pump was stopped and the lines wre reversed to improve arterial pressures and blood flow.Within 2 minutes, the patient's condition deteriorated.Upon examination, staff noticed the venous line was disconnected, fluid resuscitation attempted without success.Patient deceased.Actual lot number is unknown.Possible lot number is 19l20.

• Brand Name: NIPRO BLOOD TUBING SET WITH 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: 10237862
• MDR Text Key: 197731092
• Report Number: 8041145-2020-00007
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A372R-V858R-GT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Weight: 38