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This article was originally published in The Gray Sheet

Executive Summary

BARD DEVELOPING CORRECTIVE MODIFICATIONS FOR HYDRO-FLO PULSE IRRIGATOR that would rectify design flaws that led to a Class I recall of the device. Bard engineers are trying to modify the device in order to eliminate the potential for its latex diaphragm to rupture. The company recalled the device, which is manufactured by its Davol subsidiary, in October after in-house testing revealed the diaphragm problem. The firm also ceased distribution of new Hydro-Flo devices and does not plan to recommence shipments until a solution to the problem is found and cleared by FDA. The Hydro-Flo is used to irrigate the uterus with saline solution during procedures such as a hysterectomy. In order to pump the solution, the device makes use of compressed gas that is forced against the latex diaphragm. Bard's in-house testing found that the diaphragm could rupture in a small number of cases. Rupture "could result in gas introduction into the uterine cavity, causing an air embolism and possible life-threatening complications," according to FDA's Jan. 20 Enforcement Report (FDA's Jan. 20 and Jan. 27 Enforcement Reports are reprinted below). Bard has not received any field reports of device failure, patient injury or death related to the Hydro-Flo. All Hydro-Flo customers have been informed of the potential risk of using the device, the company says. Of the roughly 27,000 units distributed, all but 200 have been returned to Bard. Three days before initiating the Hydro-Flo recall on Oct. 26, Bard issued a safety alert on Davol's Arthro-Flo, an irrigation pump used in arthroscopic procedures. Bard issued the safety alert because "the device is contraindicated in hysteroscopy due to diaphragm failure," according to the Enforcement Report. Marquette Electronics says its recall of 196 Responder Series 1500 defibrillators is about half complete. The recall was initiated because "several" field reports revealed a potential problem with electrocardiogram sensing; FDA's Jan. 20 Enforcement Report deemed the action a Class I recall. Marquette received reports in the spring of 1992 that the Responder had failed to provide an advisory that the patient was not properly connected to the device when it failed to provide ECG tracings. As a result, the device incorrectly indicated that the patient's heart was not beating. The phenomenon occurred when there was high signal impedance between the patient and the device's sensors, according to Marquette. No patient injuries or deaths have been associated with the problem, according to the company. Marquette did not initiate a recall at the time it received the initial reports because it could not duplicate the event. However, the firm did advise users to properly prepare patients in order to avoid high impedance. After duplicating the event in- house and determining the cause, Marquette initiated the recall in October 1992. Marquette expects to rap up the recall in several months. The firm is making field repairs on some of the defibrillators and repairing others at its Milwaukee, Wisconsin manufacturing facility. To correct the problem, Marquette is enhancing the amplification signal of the device so that it will sense a patient's pulse even in cases of high impedance. In an Oct. 28 recall letter, Marquette tells users that "until these modifications have been completed" they should "exercise extra care in patient skin preparation." The company adds: "If this procedure doesn't show ECG signal, use of defibrillator pads will help decrease the possibility of this condition."

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