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

Model Number A372R-V858R

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914)

Event Date 07/04/2023

Event Type  malfunction  

Event Description

It was reported by our customer that less than half an hour into treatment, the patient didn't feel well, and the medical team noticed that there was large amount of blood on the patient and around her.The patient was pale, with low blood pressure.Dialysis was stopped and fluids were returned directly to the catheter.After the patient was positioned, the blood line set was checked and it turned out that there was a hole in it, and blood was leaking through this hole.The patient dropped 2 grams of hemoglobin.The patient received 2 doses of blood and resumed dialysis with another set.The patient finished the treatment safely and returned to the department.Additional information received from the customer: the primary nurse reported that there was some water in frront of the machine before she connected the patient.

• 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 33172 ; 3055997174
• MDR Report Key: 17375589
• MDR Text Key: 319549636
• Report Number: 8041145-2023-00006
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K182940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A372R-V858R
• Device Lot Number: 23B07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2023
• 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