MAUDE Adverse Event Report: CITRA LABS, LLC ANTICOAGULANT CITRATE DEXTROSE SOLUTION, SOLUTION A, USP; ACD-A

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

No corrective action is required for this event as it was the result of user error (not following the instructions for use).The potential medical consequences and severity of this event (e.G.Citrate toxicity).Including any mitigation (monitor the patient's ionized calcium levels and infusion of calcium).Is based on amount infused.Citrate is rapidly metabolized in vivo with a reported half-life of 1.5 minutes;therefore based on the very low dose of citrate infused to this patient no adverse reaction would be expected.This is consistent with what was reported by the pharmacist in this patient, the amount of citrate that was injected (1.2 ml or 0.026 grams of total citrate, expressed as citric acid) was compared to the amount contained in a unit ·of whole blood (500 ml), which is collected into 67 ml of a citrate-based anticoagulant (or approximately 1.45 grams of total citrate expressed as citric acid).The amount of total citrate contained in a standard transfused unit of whole blood is approximately 55 times greater than the dose (1.2 ml) that this patient received.Information regarding risk hazards and analysis can be found in the acd-a technical file revision 15 dated 15sep2017.Even though there was no serious injury reported and the investigation does not identify risk to the patient, there was a user error on the part of the attending physician.This decision tree was reopened in june of 2019 based on an independent review of the complaint and the circumstances surrounding the event.Although the patient was monitored and did not show any signs or symptoms of citrate toxicity or experience any other adverse event, we believe that the user error of direct infusion by the attending physician against the instructions for use warrants an adverse event reporting.

Event Description

Citra labs received a phone call inquiry on 01 may 2018 from (b)(6) (pharmacist) to inform citra that the end user accidentally infused 1.2 ml of acd-a (iv) into a patient and was asking for information regarding how to monitor the patient.The phone call on 01 may 2018 was very brief because the pharmacist wanted to relay the information back to the treating physician.The pharmacist indicated that she would call back to provide further details; however never called back.

• Brand Name: ANTICOAGULANT CITRATE DEXTROSE SOLUTION, SOLUTION A, USP
• Type of Device: ACD-A
• Manufacturer (Section D): CITRA LABS, LLC; 55 messina drive; braintree MA 02184
• Manufacturer (Section G): CITRA LABS, LLC; 55 messina drive; braintree MA 02184
• Manufacturer Contact: shari bailey ; 55 messina drive; braintree, MA 02184 ; 7818489386
• MDR Report Key: 8843011
• MDR Text Key: 152759300
• Report Number: 0001216032-2019-00001
• Device Sequence Number: 1
• Product Code: KSB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9350
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other