MAUDE Adverse Event Report: TCM COMBIM MODULE

Model Number	903-111
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Codes	Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)
Date of Event	07/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please note that the tcm combim monitoring system consist of a tcm base unit (item number: 391-880) and the combim module (903-111).The combim module is referenced as this is the affected model in this report, however please note that the serial number and udi number provided , is associated to the tcm base unit, as this is the only serial number currently known from the complaint.Further, please not that the manufacturing date in field is associated to the base unit (391-880).In the report the serial number and associated udi number has been stated for the base unit with serial number: (b)(4).As the customer is not sure whether the base unit involved in the incident was the one with serial number (b)(4), the udi for n006 is included here: (b)(4).
Event or Problem Description
A set of twins 32 weeks of age were monitored by two tcm combim monitors (serial numbers (b)(4)).Twin (a) appeared to have a bruise on her outer thigh.The customer also states that this patient has similar deep red marks bilaterally as well on her back; up by her shoulders.The other twin (b) had no concerns or issues at this time.The customer reached out for a wound consult who recommended to use radiogel sheets every 2 to 3 days and follow up.Both monitors were taken off the patients and no longer in service.The customer states she does not know which monitor was on each twin, but the monitor ending in n005 was set to 44 degrees c, site time set to 6 hours, and the co2 alarm is set to off.The monitor ending in n006 was set to 42 degrees.Have not confirmed if the co2 alarm was on or off or the length of time set on the site time.Both monitors time and date was incorrect.The sensor placement on twin a was alternating between outer legs beginning at 1030 am on 7/15 to 7/16.On 7/17 the sensor placement changed to the back for approx.For 6 hours until it was removed off of twin a on the morning of 7/17.At this time both monitors were taken off of both babies.
Additional Manufacturer Narrative
By a mistake this additional information was not included in the mdr 3002807968-2020-00034 follow-up #1 report.Please see the additional information below: the sensor placement on the patient was alternating between outer legs beginning at 10:30 am on 7/15 to 7/16.On 7/17 the sensor placement changed to the back for approx.For 6 hours until it was removed off of the patient on the morning of 7/17.According to tcm tosca/combim operator's manual (201811i9, page 6-3) the recommended maximum sensor application time is 4 hours for a maximum sensor core temperature of 44°c for neonates (excluding preterm infants) and adults.The root cause is determined as too long exposure to a sensor temperature of 44°c.All h6 codes have been updated in this mdr follow-up #2 report to follow the new layout of the medwatch form 3500a.It has not been possible to fill out the 'health effect -impact code' in h6 in the esubmitter system.The code should be "appropriate term/code not available".

• Brand Name: TCM COMBIM MODULE
• Common Device Name: TCM COMBIM MODULE
• MDR Report Key: 10406799
• Report Number: 3002807968-2020-00034
• Device Sequence Number: 11401117
• Product Code: LKD
• UDI-Device Identifier: 05700699031112
• UDI-Public: (01)05700699031112
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2020

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
• Operator of Device: Health Professional
• Device Model Number: 903-111
• Device Catalogue Number: 903-111
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 08/17/2020; 08/17/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 09/08/2020; 09/08/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 WK