ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
Report
- Report Number
- 3006425876-2022-00546
- Event Type
- Death
- Date Received
- June 24, 2022
- Date of Event
- December 12, 2021
- Report Date
- May 31, 2022
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS FOR USE PROVIDED WITH THIS KIT STATES: "PRACTITIONERS MUST BE AWARE OF COMPLICATIONS ASSOCIATED WITH CENTRAL VEIN CATHETERS INCLUDING CARDIAC TAMPONADE SECONDARY TO VESSEL WALL, ATRIAL OR VENTRICULAR PERFORATION, PLEURAL AND MEDIASTINAL INJURIES, AIR EMBOLISM, CATHETER EMBOLISM, THORACIC DUCT LACERATION, BACTEREMIA, SEPTICEMIA, THROMBOSIS, INADVERTENT ARTERIAL PUNCTURE, NERVE DAMAGE, HEMATOMA, HEMORRHAGE, DYSRHYTHMIAS, BRACHIAL PLEXUS INJURY, CARDIAC ARRHYTHMIA, EXSANGUINATION, HEMOTHORAX, LUMINAL THROMBOSIS, PNEUMOTHORAX, SUBCUTANEOUS HEMATOMA, AND RETROPERITONEAL BLEED". "THE PRACTITIONER MUST BE AWARE OF POTENTIAL AIR EMBOLISM/HEMORRHAGE ASSOCIATED WITH LARGE-BORE CATHETERS. DO NOT LEAVE OPEN NEEDLES OR CATHETERS IN CENTRAL VENOUS PUNCTURE SITES. TO LESSEN THE RISK OF DISCONNECTS, ONLY SECURELY TIGHTENED LUER-LOCK CONNECTIONS SHOULD BE USED WITH THIS DEVICE. IT IS RECOMMENDED THAT THE EXTENSION LINES BE KEPT CLAMPED AT ALL TIMES WHEN NOT IN USE BECAUSE OF THE CATHETER'S LARGE LUMENS. FOLLOW HOSPITAL PROTOCOL TO GUARD AGAINST AIR EMBOLISM/HEMORRHAGE FOR ALL CATHETER MAINTENANCE". "DO NOT APPLY EXCESSIVE FORCE IN REMOVING GUIDE WIRE OR CATHETERS. IF WITHDRAWAL CANNOT BE EASILY ACCOMPLISHED, A CHEST X-RAY SHOULD BE OBTAINED AND FURTHER CONSULTATION REQUESTED." WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
IT WAS REPORTED THAT A LEAK OF THE INFUSION WAS OBSERVED AT THE LEVEL OF THE CATHETER OPENING. INFORMATION RECEIVED ALLEGES THAT THE CATHETER WAS IMMEDIATELY REMOVED WHEREAS IT WAS PLANNED TO BE REMOVED THE NEXT DAY. IT WAS REPORTED THAT JUST AFTER THE REMOVAL THERE WAS A QUICK DETERIORATION OF THE RESPIRATORY AND NEUROLOGICAL CONDITION. PATIENT WAS TRANSFERRED TO INTENSIVE CARE. A CARDIO-RESPIRATORY ARREST ALLEGEDLY OCCURRED AND RESULTED IN DEATH. THE CAUSE OF DEATH WAS REPORTED TO HAVE BEEN DUE TO AN AIR EMBOLISM. ADDITIONAL AND CLARIFYING INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER.
IT WAS REPORTED THAT A LEAK OF THE INFUSION WAS OBSERVED AT THE LEVEL OF THE CATHETER OPENING. INFORMATION RECEIVED ALLEGES THAT THE CATHETER WAS IMMEDIATELY REMOVED WHEREAS IT WAS PLANNED TO BE REMOVED THE NEXT DAY. IT WAS REPORTED THAT JUST AFTER THE REMOVAL THERE WAS A QUICK DETERIORATION OF THE RESPIRATORY AND NEUROLOGICAL CONDITION. PATIENT WAS TRANSFERRED TO INTENSIVE CARE. A CARDIO-RESPIRATORY ARREST ALLEGEDLY OCCURRED AND RESULTED IN DEATH. THE CAUSE OF DEATH WAS REPORTED TO HAVE BEEN DUE TO AN AIR EMBOLISM. ADDITIONAL AND CLARIFYING INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1057157 | ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM | CATHETER PERCUTANEOUS | DQY | ARROW INTERNATIONAL LLC | IPN038300 | 71F20E0596 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death | NOT REPORTED| NOT REPORTED |