MAUDE Adverse Event Report: NIKKISO CO.,LTD DBB-06 HEMODIALYSIS DELIVERY SYSTEM; HIGH PERMEABILITY HEMODIALYZER

Model Number DBB-06

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)

Patient Problems Cramp(s) (2193); Weight Changes (2607)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

Based on the reported information of tfd141 lvs(level switch) alarm, we presume the following scenario as a probable cause of this event.When certain amounts of deaerated air comes into the gs (gas separator) 2 chamber, the lvs is activated and the valve is opened to drain the deaerated air.If the valve is open for more than 60 seconds in a therapy or 5 seconds out of 10, the tfd141 lvs alarm is triggered to alert the operator.If the lvs is activated by some other reason, some dialysis fluid may be lost to drain, and it might cause unexpected fluid loss.However, under tfd141 alarm, the machine stops to supply /suction dialysis fluid to/from dialyzer, and it is confirmed that there is no additional fluid loss while the alarm is activated.In the operator's manual of the dbb-06, the operator's intervention for this alarm is described: ".To not repeat to "reset" the alarm if it was triggered again, and to contact a trained technical staff." in the reported event, the tfd141 lvs alarm was triggered several times during the treatment, but each tfd141 alarm was reset by the nurse.

Event Description

Patient (b)(6) was set for (b)(6) kg goal; (3.5 hours).On (b)(6) 2017 during dialysis treatment, the patient became symptomatic about one hour and a half into the treatment.The patient started to complain about left leg cramping, then arm, ribs and then abdomen.It was at that point that the patient's blood was returned and treatment was terminated.The machine displayed tfd141 lvs alarm several times during the treatment, but it was reset by the nurse.The nurse discovered the discrepancy between the uf on the screen and uf entered so he weighed the patient and discovered that the patient lost (b)(6) kg, (not (b)(6) kg as stated on the screen).The patient was treated at the dialysis clinic with 500-700 ml of normal saline.Symptoms were relieved and patient was discharged home in stable condition.The patient returned for his next dialysis treatment on (b)(6) 2017.The treatment was tolerated well with the exception of some mild cramping at the end of the treatment.The patient is a latino construction worker and is not consistent with scheduled treatment for the week (patient missed (b)(6)) then dialyzed again on (b)(6) 2017 without any issues.

• Brand Name: DBB-06 HEMODIALYSIS DELIVERY SYSTEM
• Type of Device: HIGH PERMEABILITY HEMODIALYZER
• Manufacturer (Section D): NIKKISO CO.,LTD; 20-3, ebisu 4-chome; shibuya-ku; tokyo, 150-6 022; JA 150-6022
• Manufacturer (Section G): NIKKISO CO.,LTD; 498-1; shizutani; makinohara-shi, shizuoka 421-0 496,; JA 421-0496,
• Manufacturer Contact: toshio ohmori ; 20-3,ebisu 4-chome; shibuya-ku; tokyo, 150-6-022 ; JA 150-6022
• MDR Report Key: 10982893
• MDR Text Key: 220650602
• Report Number: 8031561-2020-00007
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DBB-06
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2017
• Initial Date FDA Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BLOOD TUBING LINE,DIALYZER
• Patient Outcome(s): Other
• Patient Weight: 67