MAUDE Adverse Event Report: 96" MRI TRANSPORT CIRCUIT; NONE

Lot Number 08272013U01

Device Problems Disassembly (1168); Misconnection (1399)

Patient Problem No Information (3190)

Event Date 03/14/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, (b)(4), received a phone call from (b)(6), stating that the circuit, part number 9317, lot number 08272013u01, was not assembled and that it was dangerous unless a very savvy clinician was available to attach the tubing end of the assembly and not the end that connects to the portable ventilator.On (b)(6) 2014, (b)(4) stated that they had purchased (b)(6) of the westmed mri circuits (product code 9317).Of the (b)(6) mri circuits purchased, the hospital had used twenty (20) circuits and found that an additional ten (10) circuits were connected incorrectly within the package i.E., the corrugate tubing was connected to the pt connection of the manifold instead of connecting to the tubing connection.On (b)(6) 2014, (b)(4), met with (b)(6).When she was asked if she thought it would be possible for someone in the hospital, with good intentions to save time prior to pt use, to attach the circuit and valve while it remained in the packaging.She responded, "i don't have a crystal ball but i guess that could have happened".She said two or three mri circuits which were connected incorrectly within the package, were used on pts and she had an additional three mri circuits which were also connected incorrectly.Therefore, the number of incorrectly connected mri circuits would be five or six, not ten, as she had stated on (b)(6) 2014.

Manufacturer Narrative

There are many discrepancies reported by (b)(6): on (b)(6) 2014, she reported that the tubing was unattached from the peep valve on all of the circuits and that nothing was incorrectly assembled by westmed.On (b)(6) 2014, she confirmed that ten circuits were incorrectly assembled in their packages.On (b)(6) 2014, she said that two or three mri circuits, which were connected incorrectly within the package, were used on pts and she had an additional three (3) mri circuits which were also connected incorrectly.Therefore, the number of incorrectly connected mri circuits would be five or 6, not ten, as she had stated on (b)(6) 2014.Our internal investigation support or conclusion that all mri circuits (product code 9317) manufactured, including lot number 08272013u01, were assembled and shipped correctly from westmed.It appears that the product shown by phyllis snyder at anaheim memorial regional medical center, with the tubing attached incorrectly, was a result of somebody attaching the tubing without opening the polybag which was sealed at westmed and inadvertently attached it incorrectly at the hospital.Westmed's conclusion is that the pt incident happened due to user error.The statement from (b)(6) that this problem had occurred on two different ventilator supported, critically ill pts during transport, due to a misconfiguration of the mri circuit, in which it is the rt's responsibility to properly connect the critically ill pt to the transport ventilator and monitor their vital signs during transport, is very difficult to believe for the following reasons: the rt's had been using this product for 2 1/2 months and were required to attach the corrugate tube to the ventilator tube on the manifold and the et tube at the pt end of the manifold each time they used the product.The respiratory therapist would see the product int he polybag and recognize it was different.The hospital would only transport one ventilator supported pt at a time.

• Brand Name: 96" MRI TRANSPORT CIRCUIT
• Type of Device: NONE
• Manufacturer Contact: alexa donaldson ; 5580 s. nogales highway; tucson, AZ 85706
• MDR Report Key: 4425736
• MDR Text Key: 5283717
• Report Number: 2028807-2014-00003
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 08272013U01
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 87 YR
• Patient Weight: 75