MAUDE Adverse Event Report: LIEBEL-FLARSHEIM BASE SYSTEM,ILLUMENA,NON-OEM

Model Number 900006

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Arcing (2583)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Overall investigation summary: a customer reported to guerbet's regional service, that while they were preparing for a case, they plugged their illumena injector into their siemens scanner, using the interface cable.When the cable's contacts met the scanner's, there was an electrical spark/arc between the cable and scanner's connecting pins.The operator originally reported a `jet flame' and a burning odor, and that connector pins were burnt.Because of the burn odor, the operator moved the patient to another room to complete preparation and finish the case.Guerbet's quality assurance followed up with the regional service manager regarding the "jet of flame' comment mentioned by the operator.The service manager noted that this is perhaps an interpretation issue, as the operator was most likely surprised by the sparking, which can occur during connecting/disconnecting a power cable when the system is powered up.The interface cable connector pins were reported to be burnt from the spark.This type of connector damage is typical, when users unplug a device prior to powering it down.Older model illumena injector service manuals, pn 900955 rev f, sec 2.9.8, single cable universal interface (siemens), contains the following warning: " prior to interfacing the angiomat illumena contrast delivery system to an imaging system, ensure all imaging system inputs and relay/switch outputs are not greater than +24vdc @ 40 ma.See manufacturer's data sheet for i/o specifications before attempting the interface wiring".Some of the older film changers use ac relays which if connected directly to the angiomat illumena contrast delivery system may cause equipment damage and could result in a hazard causing personal injury or death." newer neo illumena injector service manuals, pn 903955, sec 2.9.4 contains this statement: single cable universal interface (siemens)! warning! "turn power off at powerpack before connection of siemens cable" the damaged interface cable was replaced, the injector tested by regional service and found to be operating according to specifications.It was therefore put back in to use by the customer.A review of the complaint database shows that in april 2011 an issue was reported on this unit where the siemens interface cable was replaced due to burnt connector pins.Impact assessment summary: na.Root / probable cause code.Process/methods - inadequate/incorrect procedure.Root / probable cause summary.The burnt interface connector pins is a known issue that was addressed by capa (b)(4), which added a warning label to the siemens interface cable reminding the customer to turn off system power before unplugging the cable.However, since the capa, occasionally the same issue will be reported.No further investigation needed at this time.Qa will continue to monitor/trend for similar issues and identify significant quality trends to input for additional corrective action if needed.Complaint confirmed: yes.Disposition summary: unit remained in full service.

Event Description

Incident reported by facility on 25 september 2020 for an event that occurred on an unknown date.Facility stated that during the preparation for a hybrid operation (patient was already in the room, was already intubated ventilated)the contrast medium pump was coupled with the system table of the angiography system.There was an arcing at the plug connection between the table and the pump (according to the report of user with a jet of flame) and as a result strong odor formation from burned plastic.The system was shut down immediately and the ventilated patient was moved to another operating room.

• Brand Name: BASE SYSTEM,ILLUMENA,NON-OEM
• Type of Device: BASE SYSTEM,ILLUMENA,NON-OEM
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e. galbraith rd; cincinnati OH 45237
• Manufacturer Contact: fred reckelhoff ; 2111 e. galbraith rd
• MDR Report Key: 10743012
• MDR Text Key: 214766077
• Report Number: 1518293-2020-00029
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K963071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900006
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1