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Catalog Number VASCULAR UNKNOWN |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Reaction (2414); No Code Available (3191)
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Event Date 01/01/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The specific event date, customer facility name/contact information, product code, lot#, patient condition and sample availability are all unknown.No further action is required at this time.If additional information is provided the complaint will be updated accordingly.
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Event Description
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According to a case report in an article - canadian anesthesiologists society from 2019 for events that occurred in (b)(6): "this (b)(6) male with esrd secondary to hypertension and type-i diabetes presented for transplantation in 2015.Immediately following insertion of a chx-coated arrow g+ard blue plus cvl, the patient developed hypotension and increased airway pressure which responded to epinephrine, norepinephrine, dobutamine and calcium gluconate.Serum tryptase was markedly elevated two hours after the event (101ugl).Subsequent allergy testing revealed negative skin test results to basilixmab and other drugs given pre and intraoperatively whereas skin test results and immunocap for specific iges to chx were positive".
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Event Description
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According to a case report in an article - canadian anesthesiologists society from 2019 for events that occurred in toronto, canada: "this 69 year old male with esrd secondary to hypertension and type-i diabetes presented for transplantation in 2015.Immediately following insertion of a chx-coated arrowg+ard blue plus cvl, the patient developed hypotension and increased airway pressure which responded to epinephrine, norepinephrine, dobutamine and calcium gluconate.Serum tryptase was markedly elevated two hours after the event (101ugl).Subsequent allergy testing revealed negative skin test results to basilixmab and other drugs given pre and intraoperatively whereas skin test results and immunocap for specific iges to chx were positive".
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Manufacturer Narrative
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Qn#(b)(4).The specific event date, customer facility name/contact information, product code, lot#, patient condition and sample availability are all unknown.No further action is required at this time.If additional information is provided the complaint will be updated accordingly.In the customer description, the customer stated that an arrow gard blue catheter was used as part of this procedure.The customer also indicated that the patient had an allergy to chx (chlorohexidine), which is a contraindication to arrow gard blue catheters (which contains chx).A device history record review could not be performed as the material# and the lot# was not provided by the customer.The ifu for the finished kit involved with this complaint could not be reviewed as the material and lot numbers were not provided; however, the ifus for coated catheters in general state that, "the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine acetate, silver sulfadiazine, and/or sulfa drugs".The report of a catheter related allergic reaction was confirmed through the customer description.The customer stated that a chlorohexidine coated catheter was used in the procedure.Additionally, it was confirmed that the patient suffered from an allergic reaction to chlorohexidine.Based on the information provided by the customer and the confirmation that a coated catheter was used, unintentional user error (patient condition) caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
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Search Alerts/Recalls
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