Heart-Pumping, or Heart-Stopping Device?

An investigation is underway to determine whether or not MicroMedCardiovascular, maker of pediatric heart pumps, should have reported the death of a recipient of the pump. The FDA-approved pump, called DeBakey VAD Child Device was designed by Michael DeBakey, a well-known surgeon, and is the only pump of its kind. The manufacturer is required to report any deaths related to and/or caused by the device within 30 days.

The death involved a four-year-old cancer patient whose heart was weakened from rounds of chemotherapy. The heart pump was believed to be the patient’s only viable option for survival, but even after receiving the pump, the patient died. The pump manufacturer says the pump did not cause or contribute to the patient’s death and that the patient died from complications from chemotherapy and anticoagulant medicines. Still, MicroMed says it will comply with the FDA’s requests for documentation and any other information the FDA requires.

The issues here are a little tricky. If MicroMed truly believes its pump had nothing to do with the patient’s death, then should it stil report the death to the FDA? And doesn’t it benefit MicroMed to withhold such a report? Filing a report means someone will investigate or question, and isn’t it best if no questions are asked? The FDA, on the other hand, insists that these reports are not reports of guilt or wrongdoing but provide important information. Because the pump was used on a patient who subsequently died, a report should have been filed, or so the FDA believes. What do you think? Should MicroMed have reported the death?