The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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It was reported that they got alarm 79 (non-recoverable system error, primary and secondary water temperatures differ by greater than 1c).They were treated patient with s/n (b)(6).They powered the device off and back on again.When they powered it back on they got an alarm that the reservoir was empty and walked nurse through emptying the pads.Nurse received alarm 3 (water reservoir empty).Assisted nurse with filling the reservoir and reconnected pads using proper technique.The flow was 2.1 lpm.They explained if alarm 79 returns send device to biomed, otherwise it was okay to continue therapy.
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