The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
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The customer states that the unit won't stop leaking.Upon follow up request for more information on (b)(6) 2018 the customer states that the recertification pump set was leaking, the product and lot numbers are unknown, and will not be returned because the set was disposed off.
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