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news: goverment investigation! Courier Mail:

Cable glitch prompts Ventracor pump recall
Liam Walsh
09sep05
ARTIFICIAL heart maker Ventracor has been forced to recall its device,
which is being trialled, after problems emerged with a cable following
a patient's death.




Describing the move as being "in the interests of patient safety",
Ventracor said parts of devices being trialled on about 20 patients
and about 10 devices in hospitals would be quickly replaced.

Sydney-based Ventracor would not confirm or deny any patient's death,
but the Federal Government's Therapeutic Goods Administration said it
was taking "the matter very seriously and is investigating how it
happened".

"We understand there has been one death," TGA spokeswoman Kay McNiece
said. But she stressed that the patient would already have been very
sick and a direct link had not been confirmed.

Patients also gave consent when undergoing trials, she said.

Ventracor chief executive officer Colin Sutton said only short-term
delays would affect trial recruitment and it would have an undisclosed
but immaterial financial impact.

Medical devices sometimes suffer setbacks – fellow biotech Sunshine
Heart had to remove an implant recently after a patient suffered a
chest infection.

Ventracor's device is called VentrAssist, a titanium 298g heart pump
device being trialled across the globe.

Supplied cables that connect an external controller to the device had
a manufacturing "anomaly".

"It was reported to us by one of our investigating sites," Dr Sutton said.

"They had seen an incident in the field. Our device has a recorder . .
. and we were able to download the history of the function of the
device, which revealed the problem."

The "anomaly" could potentially result in a short-circuit.

"We're just swapping controllers," he said. This did not involve
surgery or re-implantation for patients with the device.

It was expected to be completed by the end of next week.

When in a pilot trial in 2003 and last year, Ventracor had
occasionally released updates provided by medical investigators about
patient conditions, including deaths.

But Dr Sutton said he was unable to disclose the results of any
patients yet for current trials.

He would not confirm or deny the TGA's statement.

But Dr Sutton said he had spoken to people involved in the clinical trial.

"They've had specific advice from statisticians, that we can't talk
about individuals," he said.

He stressed that patients were sick.

The TGA's Ms McNiece said Ventracor had been co-operative, immediately
notifying the federal agency about the problem.

ABN Amro Morgans, in a client note yesterday, said the impact to
Ventracor's progress was like a "bump in the road".

"The company has acted quickly to rectify the problem."

ABN Amro Morgans did not expect any change to milestones, including
completion of recruitment of patients for one European trial by
December.

ABN Amro Morgans anticipated some short-term weakness in the share
price which yesterday fell 2¢ to $1.27.