(People’s Daily Health Client Zhao Mengmeng) On March 25, the State Food and Drug Administration issued an announcement on Medtronic’s voluntary recall of the centrifugal pump blood control monitoring system. Among them, this batch of products involved 257 units sold in China.
From the official website of the State Drug Administration
It is understood that this product is suitable for pumping blood through the extracorporeal circuit during cardiopulmonary bypass surgery. According to the recall notice, there is a difference in the maximum voltage input between the spare component and the original component of the device, resulting in an insufficient voltage specification of the host system controller module. Additionally, transient voltage spikes in the system controller module can cause problems with DC-DC converters and D88 diode failures. The above issues can cause the instrument to shut down, the user interface to not work, or even smoke and burning odors before and during use.
It is reported that this recall is a Class 1 recall. Chen Hongyan, secretary-general of the Medical Materials Branch of the China International Travel and Health Care Association, said in an interview with the People’s Daily Health Client that Level 1 is the most serious recall type, which means that using these devices may cause serious injury or death. According to the “Administrative Measures for Medical Device Recalls” issued by the former State Food and Drug Administration (from May 1, 2017), it is clearly stipulated that the third-level recall means that the use of the medical device is less likely to cause harm but still needs to be recalled The first-level recall refers to the use of the medical device that may or has caused serious health hazards.
According to the incomplete statistics of the People’s Daily health client, from September 27 to March 27, 2021, in the past six months, the State Food and Drug Administration has notified a total of 210 illegal medical device products. Among the recalls, Medtronic and its subsidiaries had a total of 10 active product recalls in half a year, 6 first-level and 4 second-level, involving nerve monitoring tracheal intubation, insulin injection pump, stent-graft system, etc.
According to public information, Medtronic was founded in 1949. According to the “Top 100 Global Medical Device Companies List in 2021” released by Medical Design and Outsourcing, Medtronic has a business of 30.117 billion US dollars. Revenue topped the list.
A quality person in charge of a medical device company once said in an interview with the People’s Daily Health Client that the medical device recall system is actually a very mature international management system for medical devices with hidden dangers. Effective mode, medical equipment products have their particularities, the production process is very complicated, and defective products will inevitably appear. Proactive recall after a problem is discovered is a responsible performance and reduces the risk of medical devices in use.
