MAUDE Adverse Event Report: REMEL INC VERSATREK; AUTOMATED MICROBIAL DETECTION SYSTEM

Catalog Number 6240-10

Device Problem Misassembled During Installation (4049)

Patient Problem Headache (1880)

Event Date 05/24/2019

Event Type  malfunction  

Event Description

On friday (b)(6), the laboratory technologists noticed a slight burning smell in the corner of their lab where several other pieces of equipment were found (including the versatrek).They could not determine which piece of equipment was emitting the smell.They opened the drawers on the versatrek and did not pinpoint the smell to be originating from the versatrek at that time.They noticed a lightbulb was not working in the lab in the same corner with the smell and hospital maintenance replaced the lightbulb on friday (thinking maybe something was wrong with the light fixture).On saturday morning, the smell was worse.There was no alarm on the versatrek and the temperature on the versatrek was stable.They moved the versatrek out from the wall and smelled near the 5 small air fans on the back of the instrument.At this point, they determined the smell was associated with the versatrek.(b)(6) from the lab called our hotline and spoke with savita on saturday morning ((b)(6) 2019).Savita was in the process of having them remove the front cover to access the power switch to turn the instrument off and the customer noticed a flame originating from inside the top of the instrument (they could see a flickering on the metal and one of the techs saw a small flame).Savita asked them to unplug the instrument immediately and call the fire department.After unplugging the versatrek, the maintenance team ensured the instrument was no threat to the lab (nothing burning).The lab set up a few fans to circulate air and later saturday, most of the smell was gone.No serious injuries reported, but the laboratory technologists complained of headaches (due to smell) between friday and saturday.Some of the techs left the laboratory due to their headaches.No damage to the lab or other equipment.Samples being sent to sister hospital nearby.

Event Description

On (b)(6), the laboratory technologists noticed a slight burning smell in the corner of their lab where several other pieces of equipment were found (including the versatrek).They could not determine which piece of equipment was emitting the smell.They opened the drawers on the versatrek and did not pinpoint the smell to be originating from the versatrek at that time.They noticed a lightbulb was not working in the lab in the same corner with the smell and hospital maintenance replaced the lightbulb on friday (thinking maybe something was wrong with the light fixture).On saturday morning, the smell was worse.There was no alarm on the versatrek and the temperature on the versatrek was stable.They moved the versatrek out from the wall and smelled near the 5 small air fans on the back of the instrument.At this point, they determined the smell was associated with the versatrek.Jessica from the lab called our hotline and spoke with (b)(6) on saturday morning (b)(6) 2019).(b)(6) was in the process of having them remove the front cover to access the power switch to turn the instrument off and the customer noticed a flame originating from inside the top of the instrument (they could see a flickering on the metal and one of the techs saw a small flame).(b)(6) asked them to unplug the instrument immediately and call the fire department.After unplugging the versatrek, the maintenance team ensured the instrument was no threat to the lab (nothing burning).The lab set up a few fans to circulate air and later saturday, most of the smell was gone.No serious injuries reported, but the laboratory technologists complained of headaches (due to smell) between friday and saturday.Some of the techs left the laboratyr due to their headaches.No damage to the lab or other equipment.Samples being sent to sister hospital nearby.

Manufacturer Narrative

Upon removal of the top lid, it was noticed that an incorrect relay was installed in the heater circuit.This single fault caused the relay to partially melt and give off an odor.The excessive heat also caused a grey sleeved wire bundle to come in contact with the #2 terminal of the dc60s5 relay.Review of the grey wire showed no signs of melting through the insulation.The incorrect relay installed was: (b)(4)crydom dc60s5, rated at 60v 5a.The correct relay which should have been installed is (b)(4) crydom csd2425 240v 25a.Note the instrument power in this circuit is 110 volts.During this process we also reviewed 201 device history records for the instruments.The scope of this review was from 10 instruments before the non-conforming through march of 2018.No anomalies or issues were noted during this review of those dhrs including the one for the non-conforming unit.Looking at the data, the life expectancy of the incorrect relay was longer than expected when exposed to 3 times the rated input voltage.In normal usage situation, the relay should have failed much sooner or immediately.Review of the service hour data, only one failure has occurred for an incorrect relay over 937 instruments with a total of 45 million service hours.The risk assessment that another instrument in service contains an incorrect relay has been determined to have a probability of rare.Review of all data shows there is not a trend of incorrect relays being installed and this is a one-off incident.However, remel will continue to monitor for this situation and re-investigate should it recur.- attachment: [summary for mdr 1924669-2019-00002.Pdf, fda meeting mintues 07-26-2019 for 1924669-2019-00002.Pdf].

• Brand Name: VERSATREK
• Type of Device: AUTOMATED MICROBIAL DETECTION SYSTEM
• Manufacturer (Section D): REMEL INC; 12076 santa fe trail drive; lenexa KS 66215
• MDR Report Key: 8729114
• MDR Text Key: 149346912
• Report Number: 1924669-2019-00002
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• PMA/PMN Number: K032306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6240-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Date Manufacturer Received: 05/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other