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

Model Number DBB-06

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Low Blood Pressure/ Hypotension (1914); Malaise (2359); Weight Changes (2607)

Event Date 07/26/2014

Event Type  Injury  

Manufacturer Narrative

Result of visiting at the facility.Our engineer visited the facility on oct (b)(6) 2014 and checked the setting (qd set, qb monitor, sub goal, pre weight, uf goal set, bolus, post weight and uf error), tfd141 alarm reset times, alarm logs other than tfd141, the leakage from dialysis fluid filter (fl1), the setting of fl1 and the abnormal service history on the dbb-06 (69003-02).As a result of the check, we realized that tfd141 alarm was occurred one time and the setting of fl1was in different from the original specification.In the case, air stays inside fl1 and caused tfd141 alarm.Analysis result of the returned float switch product: we conducted an investigation of the returned switch installed on the dbb-06 (69003-02) and checked the appearance, the electric resistance test, and the simulated dialysis test combined with the actual machine for five hours.As a result, we could not duplicate the problem.Analysis of complaint record: from the above results, we assume that it was occurred due to the fl1 setting by misuse.We have sold (b)(4) units of dbb-06 as dec 2015 globally and were informed this complaint from this facility only and we have no other incident report from other facilities.The occurrence rate is approximately (b)(4).

Event Description

On (b)(6) 2014, a machine alarm "tfd141 float switch abnormal" was raised 30 minutes into the patient's 4 hour haemodialysis treatment.The nurse referred to "nikkiso dbb 06 user guide" and had reset the alarm as recommended.After 1 hr into treatment, blood volume alarm showed greater than 20% fluid loss.The nurse checked the patient's blood pressure and found it dropped from 190/70 to 118/60.The patient complained of feeling unwell.Subsequently, ultrafiltration rate (a term for the rate of fluid removal) was minimized, patient was laid flat and 200ml normal saline was given with good effect.The treatment was continued."tfd141 float switch abnormal" alarm repeated three times for which they were reset as recommended by the machine user guide.The treatment was discontinued when it alarmed the fourth time, patient's blood returned and machine replaced.The machine was originally set to remove 2.2l of fluid from the patient; however the post dialysis weight loss measurement indicated 3 kg which meant more fluid was removed than prescribed.This was noted to the technician.The technician believed that the large weight loss could not be caused by the machine, but indicated this will be reported to nikkiso japan for investigation.On (b)(6) 2014, the technician clarified that the weight loss could have been caused by the machine, explaining that "tfd141 alarm" is activated after an accumulation of 60 seconds of gas purge time is recorded during a therapy and in the event of a float switch error it is possible some fluid could be lost to the drain.Each time the reset button is used the alarm timer is also reset, allowing more fluid to be drained.A recommendation was made not to reset the machine as originally instructed, and instead to remove the machine from the floor immediately.

• 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: 10982618
• MDR Text Key: 220647214
• Report Number: 8031561-2020-00001
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2017
• 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: AV06JE-PDIALYZER
• Patient Outcome(s): Other
• Patient Age: 52 YR