Alerts/Adverse Events

UK medical device regulatory authority the MHRA has issued a Medical Device Alert pertaining to the Ankle Evolutive System prosthesis from French company Transystème-JMT Implants. Evidence has been mounting for a while, which raises the question of whether regulatory oversight was adequate.

9 patient deaths are reportedly linked with catheter entrapment when delivering Covidien subsidiary ev3’sOnyx injectable embolic material into the brain. FDA has seen fit to warn users of the potential for this to occur.

UK competent authority the MHRA has issued a Medical Device Alert pertaining to Baxter’s Flogard and Colleague infusion pumps, one lot of which may have been incorrectly assembled.

UK competent authority the MHRA has issued an alert following the death of a patient from Hepatitis, thought to have been transmitted via an inadequately processed reusable probe.

According to a press release issued by US Law firm Bernstein Liebhard LLP, FDA has received almost 17,000 adverse event reports from 2000-2011, associated with metal hip implants, such as the DePuy ASR and Pinnacle hip systems. An FDA panel has been in session for two days to discuss the situation.

Covidien has been on the unpleasant end of FDA’s big stick, the agency having written to the company about a raft of areas in which it has found the handling of the Duet TRS stapler recall to be inadequate.

Terumo Cardiovascular Systems has issued guidance regarding what to do in the event of a false air bubble detector alarm, together with some corrections to the user manual, but is not recalling the devices, nor suggesting withdrawal from use.

Smith & Nephew had already issued a Field Safety Notice on its R3 metal acetabular liner. Now MHRA has followed up with its issuance of a Medical Device Alert including direction on patient follow-up.

St.Jude must have issued a corporate sigh of relief when its investigators concluded that the recently reported incidence of Durata ICD lead failure was most likely caused by abrasion from another lead or indeed a calcified structure, rather than the inside-out abrasion which has characterised the company’s Riata family problems.

BAAPS has issued a statement broadly supporting the conclusions of the Chief Medical Officer’s report into the PIP breast implant situation. The association is urging women to take up the offer of consultation and potential explantation, and urging the private sector providers to do exercise their own duty of care.

The news that FDA’s MAUDE database of adverse events has reported an “externalisation” of St.Jude’s new and improved ICD lead is bad timing and bad news for the company.

UK competent authority the MHRA has taken the unusual step of using its medical device alert procedures to remind anaethestists and support staff that their machines and practices need to pass muster if they are to avoid serious patient incidents.

Convincing a surgeon to use a blunt suture needle is akin to asking him to ditch the Aston Martin in favour of the Micra. It’ll work, but not in quite such a satisfying way. Maybe FDA can do a better job than we did twenty years ago when even HIV/AIDS didn’t prove convincing.

UK MHRA has issued a Medical Device Alert (MDA) pertaining to the GEMSTAR™ infusion pump manufactured by Hospira Inc. It seems the accessory Bolus Cord can become damaged and consequently fail to deliver requested medication to the patient.

UK Competent Authority on Medical Devices, the MHRA has issued a medical device alert relating to Nottingham-based Capatex Medical’s Endotracheal tube clamps which it says may result in a risk of airway loss due to slippage or airway obstruction, as a result of over-tightening of the clamp/holder.

Minnesota based Nonin Medical, Inc., has announced FDA 510(k) clearance and commercial release with expanded labelling claims for its Onyx® Vantage 9590 professional fingertip pulse oximeter.