(b)(4).The actual complaint product was not returned for evaluation.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.Root cause could not be determined.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.
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Fill volume: 249 ml, flow rate: 5 ml/hr, procedure: chemotherapy, date of procedure: (b)(6) 2016, infusion start time: (b)(6) 2016, unknown time, finished (b)(6) 2016, 21:00, cathplace: n/a.It was reported that a patient's elastomeric infusion pump was supposed to infuse for 48-hours, but infused within 32-hours.The patient became ill after the infusion, experiencing nausea, vomiting, aches, ulcers, heartburn, and skin blistering since (b)(6) 2016.It was noted that the symptoms resolved themselves over time.No additional information was provided.
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