MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-06-25 for 96" MRI TRANSPORT CIRCUIT manufactured by .
[5283717]
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.
Patient Sequence No: 1, Text Type: D, B5
[12873791]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2028807-2014-00003 |
| MDR Report Key | 4425736 |
| Report Source | 99 |
| Date Received | 2014-06-25 |
| Date of Report | 2014-06-24 |
| Date of Event | 2014-03-14 |
| Date Mfgr Received | 2014-03-18 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2015-01-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ALEXA DONALDSON |
| Manufacturer Street | 5580 S. NOGALES HIGHWAY |
| Manufacturer City | TUCSON AZ 85706 |
| Manufacturer Country | US |
| Manufacturer Postal | 85706 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 96" MRI TRANSPORT CIRCUIT |
| Generic Name | NONE |
| Product Code | BYE |
| Date Received | 2014-06-25 |
| Lot Number | 08272013U01 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-06-25 |