MAUDE Adverse Event Report: ARROW ARROW TWO LUMEN CVL KIT ; CENTRAL LINE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Airway Obstruction (1699); Anaphylactic Shock (1703); Cardiopulmonary Arrest (1765); Low Blood Pressure/ Hypotension (1914)

Event Date 05/31/2019

Event Type  Injury  

Event Description

Anaphylaxis to chlorhexidine - coated central line.Within mins of operating room placement of chg - coated cvl, pt had increased peak airway pressures and profound hypotension.He required acls, cpr, and was treated for anaphylaxis - epinephrine, hydrocortisone and diphenhydramine.Devices removed and exchanged for non - chg coated catheter with return of spontaneous circulation.Operating room case aborted.Tryptase sent - 81 ug/l.Allergy: coconut, anaphylaxis, likely from chlorhexidine.No offending agents were given, no antibiotic on board.

• Brand Name: ARROW TWO LUMEN CVL KIT
• Type of Device: CENTRAL LINE
• Manufacturer (Section D): ARROW
• MDR Report Key: 8666775
• MDR Text Key: 147041610
• Report Number: 8666775
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2019
• Distributor Facility Aware Date: 05/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR
• Patient Weight: 85