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

Model Number BL+A430/V912

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Low Blood Pressure/ Hypotension (1914); Confusion/ Disorientation (2553)

Event Date 10/22/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation report attached is on retained samples by the manufacturer only.Pending completion of final investigation on returned sample.

Event Description

Approximately 2 hours into dialysis treatment a patient had significant blood loss from venous needle connection.Facility administrator stated the connection was loose.They placed towels on the floor surrounding the blood and estimated 2-24 inches of blood.Vitals taken at 11:30am were stable and access was visualized.At about 11:45am, patient seemed confused and blood pressure was 70/38.The team was able to secure the line and return the patient's blood.Patient was then sent to the hospital for blood transfusion and observation, subsequently requiring 2nd blood transfusion.Patient returned to regular dialysis treatment on (b)(6) 2022 without complications.Other devices used: nipro surdial dx hemodialysis system, serial# (b)(4), udi: (b)(4).

Event Description

Approximately 2 hours into dialysis treatment a patient had significant blood loss from venous needle connection.Facility administrator stated the connection was loose.They placed towels on the floor surrounding the blood and estimated 2-24 inches of blood.Vitals taken at 11:30am were stable and access was visualized.At about 11:45am, patient seemed confused and blood pressure was 70/38.The team was able to secure the line and return the patient's blood.Patient was then sent to the hospital for blood transfusion and observation, subsequently requiring 2nd blood transfusion.Patient returned to regular dialysis treatment on (b)(6) 2022 without complications.Other devices used: nipro surdial dx hemodialysis system, serial# (b)(6), udi: (b)(4).

Manufacturer Narrative

Investigation report attached is on retained samples by the manufacturer only.Pending completion of final investigation on returned sample.Final investigation report attached is on retained samples and unused returned samples only.Actual device was discarded.

• Brand Name: NIPRO BLOOD TUBING SET W/TP
• Type of Device: BLOODLINE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• Manufacturer (Section G): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 15811358
• MDR Text Key: 303843418
• Report Number: 8041145-2022-00012
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BL+A430/V912
• Device Catalogue Number: BL+A430/V912
• Device Lot Number: 21A11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2021
• 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): Other; Hospitalization