[59204954]
Biomedical tech performed annual preventative maintenance on devilbiss 7305 suction unit. During maximum vacuum test (suction line occluded to generate maximum suction in canister), disposable suction canister imploded leading to catastrophic failure with plastic pieces ejecting outwards. Subsequent inspection revealed that the canister lid had severely embrittled, causing the failure. Inspection of two other devilbiss suction units in the lower mainland revealed that their lids were also embrittled. Relatively small amount of force generated by pressing on the canister lots caused them to crack. The part number 614700 was printed on the front of the affected canisters. Inquiry with devilbiss indicated that these canisters were manufactured by bemis. Historically, devilbiss 7305 pd units were sold with bemis canisters. Communications with bemis revealed that the affected canisters (part number 614700) have a 36 month shelf life. There is no evidence to show that this shelf life was ever stated by devilbiss to the consumer. Thus, the end-user of the suction device would not be aware that the disposable canister has a shelf life. Devilbiss units are used in hospital often only in emergency situation where wall suction is not available, or when wall suction fails. These situations rarely occur. Resultantly, many units have never been seen clinical use. The disposable bemis canisters which were initially shipped with the device have in many cases never been replaced. Devilbiss now manufactures their own disposable canisters in-house that have an unlimited shelf-life. There is significant concern; however that older devilbiss units could still have their original bemis canisters. These canisters have most likely expired years ago and are prone to failure due to debridement of the lids. Failure of the suction unit in an emergency scenario is the worst possible time failure could occur.
Patient Sequence No: 1, Text Type: D, B5