This suction device was utilized in a delivery that resulted in pt death, although there were no obvious defects with the product or fault in the equipment. An evaluation still needs to be performed on this device. They are unsure which lot # device was used so everything in stock was returned.

Add'l info rec'd from mfr 4/24/03: with regards to the last qsit inspection, mfr has reviewed all past complaints involving the kiwi product (including the four complaints mentioned in the inspection) and to the best of its knowledge all complaints have been handled correctly and mdr's have been filed when required. Reporter contacted mfr on march 7, 2003 regarding the pt's death. They had no details at that time. It wasn't until march 14, 2003 that mfr was able to get the details. On that date mfr spoke to the physician involved with the incident. His first statement was that he thought they were making a big problem out of the kiwi vacuum cup. He says that the vacuum cup had nothing to do with the incident. He was the physician that used the cup and he only applied vacuum for less than 2 minutes with one pull in which there was no descent. He therefore, removed the kiwi vacuum cup and tried to place forceps but could see that it was not possible. He then went to c-section. The family member had been pushing 2 1/2 hours in 2nd stage. With failure to progress, non-reassuring fetal heart tones, tachycardia, chorioamniotis, fetus was op, and +3 station, he attempted a quick trial of vacuum extraction. He had difficulty placing the cup and was unable to get suction at first so the cup slipped off. He reattached it for the next contraction, pumped down to 500 mm hg, got good traction but no descent so he removed the cup, attempted forceps but was unable to apply them, and so he went to c-section. He believes the subgaleal hematoma bleeding occurred earlier, as the large caput was present when he went to place the vacuum cup. Chignon was not formed as the cup was only on for a few minutes. He didn't feel the kiwi vacuum cup had anything to do with the subgaleal hematoma. The device was not saved or returned. Based on the physician's comments, mfr did not feel that laboratory testing or failure analysis was of any value or was needed. Based on the statement from the physician, mfr determined that the kiwi vacuum extractor did not contribute to the incident described in the medical device report.