MAUDE Adverse Event Report: LEICA BIOSYSTEMS MELBOURNE PTY. LTD BOND-MAX AUTOMATED STAINER; AUTOMATED SLIDE STAINER

Model Number BOND-MAX

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, a local leica representative detailed that: "our end user, shizuoka general hospital which has a bomd max [sic] had an incident the day before yesterday.They had a very old ups (mitsubishi electric fw-v10-1.0k for bond), and it ignited, which must have induced an incident, "fire." so far, the local fire dep.Is investigating regarding this incident so that we have no details yet however, it is reported the fire spread entire the room by media.[translated text-fire at prefectural general hospital hospitalized patients evacuated outdoors no injuries shizuoka]-youtube." on (b)(6) 2022, leica biosystems melbourne received information from a local leica representative in japan detailing that all staff, patients and related people were safely evacuated from the building; and no report(s) of any adverse impact to a patient(s) has been received by the manufacturer of the bond-max instrument due to the circumstances involved in the incident.

Manufacturer Narrative

The information available indicates that the uninterruptible power supply (ups) used by the customer in conjunction with the bond-max instrument, ignited and was the cause of the fire.The ups was supplied by a third party company.The ups is not a component of the bond system and is not supplied by the legal manufacturer of the instrument.Manufacturer evaluation of the bond-max instrument was not possible due to the nature of the incident.Investigation to date indicates that there is no adverse impact on the leica product; and the use of the third party ups in conjunction with the bond-max instrument was consistent with our labelling to the best of our knowledge.There was no malfunction of the leica bond-max instrument.There was an unknown malfunction of the ups.

Manufacturer Narrative

The shizuoka city fire department conducted an investigation/inspection by methodically disassembling the bond-max automated stainer serial number (b)(6) and examining for the possible cause of the fire.At the conclusion of the investigation/inspection it was preliminarily concluded verbally by the shizuoka city fire department that the cause of the fire was a frayed area of a loom located 350 to 400mm from the core module connector.A root cause for the cable fraying could not be identified.In the weeks since the visit to the shizuoka fire department, leica biosystems melbourne has conducted an exhaustive internal investigation of the same model variant as the bond-max automated stainer serial number (b)(6) that was destroyed in the fire.As a result of this internal investigation, leica biosystems has concluded that it is highly unlikely that a frayed wire in the bond-max automated stainer serial number (b)(6) could have been the cause of the fire.Updates to the following sections were made: -g3: date additional information was received by the manufacturer.-g6: follow-up report 02.-h2: follow-up report to provide additional information.-h6: updates to the adverse event problem codes based on additional information received.

Manufacturer Narrative

On 02 november 2022, the following information was documented by a local leica representative: "with regard to the fire incidence at (b)(6) hosp, the fire department's investigation was conducted in the presence of mitsubishi electric, the ups manufacturer.As a conclusion, the ups was cleared of suspicion, but bond is now put on the investigation list." the information received also detailed the intention that the bond-max instrument was to be investigated by the local fire department in the presence of leica biosystems representatives in november 2022.On 21 november 2022, leica biosystems melbourne received the following further complaint details from a local leica representative: - bond-max automated stainer serial number (b)(6) was not executing any staining protocol at the time of the fire.- it was not known by the complainant whether the mains power to the instrument was either on or off at the time of the fire.- "2022/09/24: 02:00:46 power outage due to bad weather; 02:01:21 switched to in-house power generation; 15:28 power restoration (resolved power outage); 16:07 fire reported".On 28 november 2022, on-site investigation/inspection of bond-max automated stainer serial number (b)(6) was conducted at the (b)(6) fire department by (b)(6) fire department and leica biosystems representatives.The (b)(6) fire department will prepare a report to detail the findings of this on-site investigation/inspection.Investigation by leica biosystems is ongoing.

Manufacturer Narrative

Leica biosystems received the (b)(6) city fire department investigation report into the fire incidence at (b)(6) hospital.The (b)(6) fire department stated "before the fire outbreak, the impact from typhoon 15 caused a power outage that lasted for about 13 hours before power was restored.The possibility cannot be denied that, during that outage, some kind of electrical abnormality in the building occurred." and concluded "therefore, the fire outbreak determinant is assumed to be that an electrical abnormality occurred due to some factor at the wiring for heater 3 [ssa3] situated inside the automatic immunostaining device, resulting in the peripheral wire sheathing igniting." after review of the (b)(6) fire department investigation report and after the exhaustive internal investigation of the same model variant as the bond-max automated stainer serial number (b)(6) that was destroyed in the fire, leica biosystems concluded it remains highly unlikely that a frayed wire in the bond-max automated stainer serial number (b)(6) could have been the cause of the fire.

• Brand Name: BOND-MAX AUTOMATED STAINER
• Type of Device: AUTOMATED SLIDE STAINER
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• Manufacturer Contact: daya currie ; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• MDR Report Key: 15712629
• MDR Text Key: 307573544
• Report Number: 8020030-2022-00105
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BOND-MAX
• Device Catalogue Number: 21.0051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2013
• 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