The patient's mother reported that the pump beeps the entire time they are infusing.The product fault occurred when in use with the patient.Unsure if the issue caused patient or clinical injury.Unsure if device is available for investigation.Device will be replaced.Unsure if patient had backup device that the patient was able to switch to.The device lot number/serial number and expiration date are unknown.No further details are available.Indication: common variable immunodeficiency, unspecified; nonfamilial hypogammaglobulinemia.Reported to (b)(6) by pt/caregiver.
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