Alerts/Adverse Events

UK regulatory agency the MHRA has issued a device alert relating to the MicroPace 4580 from Pace Medical, distributed in the UK by APC Cardiovascular. Full details of the alert and required actions can be found here.

Certain of Covidien’s Shiley, reusable cannula, cuffed trachoestomy tubes appear to have leakage and disconnection issues, which has lead to the UK’s MHRA issuing a Medical Device Alert.

UK regulatory authority the MHRA is very keen to ensure that all pertinent information on the management of the potential for externalised ICD leads, reaches the appropriate medical professional, so has issued a follow up device alert with updated guidance.

So who dropped the ball? It looks like one of Synthes Hemostatic Bone Putty’s constituents is flammable, which makes it look like the culprit in the flammable bone putty debacle.

One specific LOT of Baxter’s sterile water for irrigation may be contaminated by a bacterium. As a precautionary measure the company is acting and UK’s regulatory body has issued a device alert calling for quarantining of identified product as further investigation is performed.

UNomedical’s neria infusion sets are the subject of a Medical Device Alert in UK as a result of the identified risk of needle breakage with the consequent need for needle removal.

A “Talking” Blood Glucose Meter that doesn’t talk. A sterile urinary catheter that isn’t sterile. A reprocessing unit that risks contaminating its contents. A week in the life of UK MHRA’s safety/recalls/alerts department.

UK’s regulatory authority the MHRA has issued a Medical Device Alert(MDA) pertaining to all lot numbers and product codes of the EMS ET Tube Clamp/Holder because of a risk of airway loss due to slippage of the clamp/holder or airway obstruction as a result of over-tightening of the clamp/holder.

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.

Ethicon has issued a dire warning about inappropriate use of its Evicel® spray applicator, which raises the question of how well important information like this gets distributed outside US.

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.

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.