MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 NEEDLELESS VALVES, 3ML FLU; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number 42801-35

Device Problem Melted (1385)

Patient Problem Burn(s) (1757)

Event Date 12/07/2022

Event Type  Injury  

Event Description

The event involved a transpac¿ it monitoring kit, 84" safeset reservoir, 2 needleless valves, 3ml flush device, un-bonded macrodrip.It was reported that the transducer connected to the machine while the patient was monitored and having an mri, had melted and burned the patient.The patient was reported to be very sick and intubated prior to the event happening.The patient was treated for the burn.There was report of patient harm and no further information is available at this time.

Manufacturer Narrative

The device is available for evaluation, however has not been received.

Manufacturer Narrative

Additional information in b5.D9: device returned to mfr- 12/21/2022.

Event Description

Additional information was received by the customer stating it is undetermined what caused the transducer to heat up.The patient had a first degree burn on their arm which was cleansed and dressed.There was no delay in therapy and the patient's status did not change due to the event.

Manufacturer Narrative

Received one used.List #886-42584-05, transpac¿ iv monitoring kit, disposable transducer, 3ml squeeze flush device, macrodrip; lot #unknown.The reported complaint of burnt wire was confirmed on the returned set.During visual inspection, a portion of the the white cord was observed to be burnt on the white cable of the transpac iv transducer.Across the white cable a few twists were observed and a twist close to the burn.The probable cause of the failure mode is a twist or loop in the cable causing electrical current to form in the cable during the mri scan of the patient, and the subsequent burning of the cable.A device history (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 NEEDLELESS VALVES, 3ML FLU
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16034675
• MDR Text Key: 306007110
• Report Number: 9617594-2022-00336
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 42801-35
• Device Catalogue Number: 42801-35
• Device Lot Number: UNKNOWN
• 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
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MAGNETIC RESONANCE IMAGING, UNK MFR
• Patient Outcome(s): Required Intervention