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Summary List of field safety notices (FSNs) from medical device manufacturers from 27 November to 1 December 2017.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 October 2017.
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Caution in Use: Distribute to Hospital Pharmacy, Ward, Chemotherapy Unit and Clinic Level
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Caution in Use: Distribute to Hospital Pharmacy, Ward and Operating Theatre Level
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Strathclyde Pharmaceuticals Ltd is recalling a single batch of Xarelto 20mg film-coated tablets (Rivaroxaban) because of reports of rogue blister strips of 15 mg tablets within two packs of 20 mg tablets.
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(Focus Pharmaceuticals) Error with the barcodes on selected batches of 8 medicinal products – Class 4 Caution in Use (EL (17)A/08)
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Torrent Pharma (UK) Ltd is recalling the below batches as a precaution because out of specification results for dissolution were obtained during routine stability testing.
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Baxter Healthcare Limited are initiating a precautionary, company-led, ward-level recall of two batches of Sodium Chloride Infusion 0.9% w/v 1000 mL bags due to a potential leak with the bags.
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Manufactured by Baxter – the software fails to save the syringe type and size in service and custom modes, and so reverts to default settings.
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Pharmacy and wholesaler level recall of two batches of Parallel Imported One-Alpha Drops x 10 ml because the dropper included in this pack delivers 0.05 micrograms of alfacalcidol instead of 0.1 micrograms as labelled on the…
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Manufactured by Philips Healthcare – two battery related problems: 1) may fail to power on or reboots repetitively, 2) after unplugging from AC mains, may fail to deliver a shock or undertake pacing.
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Manufactured by Physio-Control – risk of unexpected device shutdown due to an intermittent connection between the battery and device contacts.
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All Alaris™ GS, GH, CC, TIVA, PK, Enteral Syringe Pumps, and, Asena™ GS, GH, CC, TIVA, PK, Syringe Pumps – risk of uncontrolled bolus of medicine
Manufactured by CareFusion/BD Medical – identify and replace broken backplate spring in the plunger assembly and note updated preventative maintenance schedule for these pumps
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Manufactured by Dräger – ventilator may stop working if oxide layers accumulate due to the infrequent use of the control knobs (potentiometers).
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Manufactured by Global Components Medical Ltd – if propofol leaks from the check valve Luer lock connector patients could become aware during surgery (MDA/2016/021)
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Manufactured by Medtronic – battery voltage may reduce to a point where the device is no longer able to provide patient pacing therapy - MDA/2015/038
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(All manufacturers) Low risk of Mycobacterium infection in patients undergoing cardiac surgery, associated with heater-coolers used with cardiopulmonary bypass machines. Possible cause may be Mycobacterium-contaminated water…
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(All manufacturers) Delays in acting on field safety notices can compromise patient safety (FSNs). (MDA/2014/037)
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(St Jude Medical) These defibrillators can delay or reduce the therapy that can be delivered by the ICD.(MDA/2014/035)
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(Various manufacturers) Risk if alarms are ignored or damaged breathing systems are used. (MDA/2014/020)
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(Pace Medical Inc) CE-marking suspended due to quality system failings. (MDA/2014/015)
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(Hospira) Use an alternative pump, where available. (MDA/2013/078)
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(Medtronic) 4 field safety notices concerning these products. (MDA/2013/042)
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(All manufacturers and models) Can lead to potential periods of asystole, syncope and possible death. (MDA/2013/032)
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(Hospira) Due to pump faults. (MDA/2013/016)
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(Hospira) If pump is running on mains power and software detects that battery cannot be fully recharged, an alarm will sound and infusion will stop. (MDA/2013/006)
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(Various manufacturers) Leads to dislodgement of the tube with subsequent risk of airway loss. (MDA/2012/062)
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(Invacare) Should be appropriately decontaminated between each patient use. (MDA/2012/038)
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(GE Healthcare) accidental incorrect setting of the ACGO switch results in no fresh gas flow to the patient.(MDA/2011/108)
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(All manufacturers) some pre-filled glass syringes are incompatible with some needle-free connectors; and when adaptor stays attached after use there is a possible risk of infection and or air embolus to patients. (MDA/2011/…
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(Hospira Inc) audible alarm on listed Plum A+ infusion pumps may fail, which could cause a delay or interruption to treatment. (MDA/2011/066)