CONCORD MANUFACTURING CRIT-LINE III BLOOD CHAMBER II; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
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Catalog Number 191058 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Reaction (2414)
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Event Type
Injury
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Manufacturer Narrative
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The plant investigation is in progress.A supplemental medwatch will be submitted at the completion of these activities.Clinical investigation: a temporal association with the crit-line iii blood chamber and the reported hypotension event exists.However, based on the lack of available information potential causality cannot be established.The patient was admitted to the hospital with cellulitis (unknown etiology or site) and sepsis (unknown source) and a reported drop in blood pressure (bp) occurred during the hemodialysis (hd) treatment.The hospital course is unknown.Additional information related to the patient's history, comorbidities, medical records and hospitalization is needed to determine potential causality.Although requested, this information has not been received.
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Event Description
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A facility clinic manager reported a suspected reaction to the crit-line iii blood chamber.The complainant reported that the patient was admitted to the hospital on (b)(6) 2017 with an admission diagnosis of cellulitis and sepsis (possibly catheter related).The patient was treated with multiple antibiotics during their hospitalization and underwent routine hemodialysis (hd) treatments.This event represents the second of two reported occurrences of hypotension that were experienced by the patient while undergoing hemodialysis (hd) therapy.The event date is not known.Within the first 30 minutes of the hd treatment being initiated, the patient experienced a drop in blood pressure (no reading provided).The patient was treated with medications (not specified) and completed treatment.Follow-up was provided which revealed that the user facility only uses a fresenius crit-line iii blood chamber.The hd machine, dialyzer, bloodline, acid concentrate, and bicarb concentrate were another manufacturer¿s products.The patient has since been discharged home (date unknown).The patient¿s condition at the time of their discharge was noted as being fine.The complaint device was not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.
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Manufacturer Narrative
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Plant investigation: the complaint sample was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A records review of the device manufacturing records could not be performed as the blood chamber lot number was not provided.However, a review of the production and quality control processes found no anomalies.All the involved personnel is duly trained and instrument calibration and machine maintenance status is in compliance.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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Search Alerts/Recalls
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