MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IV MONITORING KIT W/ SAFESET RESERVOIR, 24" TUBING,03 ML INTRAFLO FLU; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number 46103-68

Device Problem Overheating of Device (1437)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 03/12/2021

Event Type  malfunction  

Manufacturer Narrative

The device is not available for evaluation.Without the returned device a probable cause is unable to be determined.(b)(4).

Event Description

A user facility mandatory medwatch (# (b)(4)) was received that stated, "patient taken down to mri for abdominal with contrast.Scan was paused for patient movement.Upon entering the room again, rn and mri staff immediately noticed burning smell which was not noticed previously.Upon further investigation, rn noticed arterial bleeding from patients left radial a-line transducer site near the left upper lateral arm.Rn locked a-line to stop the bleeding and further noticed large burn site under the a-line transducer." additional information included on the medwatch: outcome attributed to adverse event, other serious (important medical events) and required intervention to prevent permanent impairment / damage (devices).Preexisting characteristics that may have contributed to the event: hepatic/renal dysfunction.It was also added under for use by user facility/importer that event happened at the hospital.Additional information received: the exact time of the event was on 10:56:00am stating the patient was intensive care unit (icu) status, and during a stat magnetic resonance imaging (mri) the cabled burned with the patient receiving a burn.The patient was hemodynamically stable and after the event, the patient remained stable in the icu.It was reported that the patient experienced a 5cmx3cm full thickness burn from transducer cable.Post treatment to the site care was managed by the plastics and general surgery team with recommendations for medical treatment and not surgical treatment at this time.The patient's current condition remained stable in the icu post thermal injury.The device was initially placed on (b)(6) 2021 and no issues noted during initial set-up/priming.The set up was performed by nursing and very experienced mri technician using standard practice that includes checking for loops and organizing and straightening wires.The patient was reported to be agitated and moving prior to scan and continued to do so during the scan, despite repositioning and pharmacologic intervention.The transpac device was not plugged in to any other cables at the time.Upon removal and replacement of the a-line segment of the device, there was no visible defects and or anomalies.There was blood loss, described as unable to quantify, but minimal at best.The affected product was replaced and therapy resumed.Defects not observed besides area burned.

Manufacturer Narrative

An onsite visit took place to look at the involved sample and talk with the customer representatives.The sample was observed to be burned just below where the white cable comes out of the transpac iv transducer.Additionally, the flush device has burn marks and appeared to have melted, opening the fluid path.Across the white cable a few twists were observed, one half twist close to the burn and an additional twist about halfway down the cable.As of now our probable cause of the failure mode is a twist in the cable underneath the flush device causing a current to form in the cable during the mri scan of the patient, and the subsequent melting and burning of the cable, plastic on the flush device and the patients arm.The lot history was reviewed and there were no nonconformities which would have contributed to the reported complaint.

• Brand Name: TRANSPAC IV MONITORING KIT W/ SAFESET RESERVOIR, 24" TUBING,03 ML INTRAFLO 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
• MDR Report Key: 11640947
• MDR Text Key: 244628963
• Report Number: 9617594-2021-00115
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00887709050723
• UDI-Public: (01)00887709050723(17)231201(10)5101172
• Combination Product (y/n): N
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: 46103-68
• Device Catalogue Number: 46103-68
• Device Lot Number: 5101172
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 100