SMITHS MEDICAL ASD INC. PORTEX CUSTOM SINGLE LIMB CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
|
Back to Search Results |
|
Catalog Number C1110 |
Device Problems
Detachment Of Device Component (1104); Leak/Splash (1354)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
|
|
Event Description
|
The customer reported the breathing circuit passed the initial leak test.Then, about 1 hour into the case, the leak alarm sounded.All the connections were checked and it was discovered that the machine side connection to the filter (near the patient) became loose.It was tightened and the leak was resolved.A short time later, the leak alarm went off again.Trouble-shooting revealed that the expiratory connection to the machine had loosened and caused a leak.The connection was retightened.No patient injury was reported.
|
|
Manufacturer Narrative
|
One portex® custom single limb circuit was returned for investigation.The device was received inside a plastic bag with its original closed packaging.The customer reported that two devices contributed to two reported events (one device per event).The customer returned one device for evaluation.It could not be determined which reported occurrence that device was associated with; therefore, the evaluation of the device will be used for the medwatch.The following mfr were submitted related to the evaluation: 2183502-2016-01676 and 2183502-2016-01677.Visual inspection found no deformations/holes along the tube and the device was correctly assembled; no defects were observed.Additionally, no holes were found on the breathing bag.During functional testing, the returned tube and bag were connected to the leak testing device; no leaks were detected.The returned device then underwent a retention and bond strength test using a calibrated weight and brackets.During the strength and bond test, no separation on the parts or on the bonding was observed.After the strength and bond test, the tube and bag were reconnected to the leak testing device; no leaks were observed.Investigation was unable to find fault with the returned device and found that the device operated as intended.(b)(4).
|
|
Search Alerts/Recalls
|
|
|