COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY
Report
- Report Number
- 1820334-2024-00435
- Event Type
- Malfunction
- Date Received
- March 28, 2024
- Date of Event
- March 13, 2024
- Report Date
- September 17, 2024
- Manufacturer
- COOK INC
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D2A- ADDITIONAL COMMON NAME: (B)(6), FOR PERCUTANEOUS CATHETERIZATION. D2B- ADDITIONAL PRODUCT CODE: (B)(6). D4- RPN: MOST LIKELY A UTLMY-7.0-32-1-20-IH, AS THIS IS THE DEVICE THE FACILITY REGULARLY ORDERS. E3- OCCUPATION: VALUE ANALYSIS MANAGER. G4- PMA/510(K) #: K182252. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THAT THE CATHETER IN A COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY WAS OCCLUDED. THE VASCULAR TEAM WAS CALLED IN TO ASSESS THE OCCLUDED DEVICE WHILE THE PATIENT WAS IN THE ICU. THE LINE HAD BEEN IN PLACE LESS THAN 24 HOURS. THE USER WAS ABLE TO RESTORE FLOW TO THE LINE, BUT NOTED THE BLUE LUMEN WAS OBSTRUCTED AND HAD BLOOD BACKING UP INTO THE LUMEN. THE DISTAL PORT WAS ABLE TO BE FLUSHED EASILY BUT HAD NO BLOOD RETURN. IT SHOULD ALSO BE NOTED THAT THE FACILITY HAD NOT YET RECEIVED TRAINING ON THE PRODUCT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE. IT IS UNKNOWN IF THE DEVICE HAD TO BE REPLACED. REVIEWS OF THE DOCUMENTATION, INCLUDING THE QUALITY CONTROL PROCEDURES AND INSTRUCTIONS FOR USE FOR THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED, DUE TO THE LACK OF LOT INFORMATION FROM THE COMPLAINT FACILITY. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. COOK ALSO REVIEWED PRODUCT LABELING: THE PRODUCT IFU, [C_T_CTEULM_REV1] ¿COOK UNIMPREGNATED CENTRAL VENOUS CATHETER WITH POWER INJECTION,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: CATHETERS AVAIBLE FOR USE SUGGESTED CATHETER MAINTENANCE: ¿TO PREVENT CLOTTING OR POSSIBILITY OF AIR EMBOLUS, THE DOUBLE LUMENS #2, THE TRIPLE-LUMENS #2 AND #3 LUMENS, AND THE FIVE LUMENS #2, #3, #4, AND #5 LUMENS SHOULD BE FILLED WITH SALINE SOLUTION OR HEPARINIZED SALINE SOLUTION (100 UNITES OF HEPARIN PER ML OF SALINE IS USUALLY ADEQUATE), DEPENDING ON INSTITUTIONAL PROTOCOL PRIOR TO CATHETER INTRODUCTION. ANY UNUSED LUMENS SHOULD BE MAINTAINED WITH CONTINUOUS SALINE OR HEPARINIZED SALINE DRIP OR LOCKED WITH HEPARINIZED SALINE SOLUTION. HEPARIN-LOCKED LUMENS SHOULD BE REESTABLISHED AT LEAST EVERY 8 HOURS. BEFORE USING ANY LUMEN ALREADY LOCKED WITH HEPARIN, THE LUMENS SHOULD BE FLUSHED WITH TWICE THE INDICATED LUMEN VOLUME USING NORMAL SALINE. LUMENS SHOULD BE FLUSHED WITH NORMAL SALINE BETWEEN ADMINISTRATIONS OF DIFFERENT INFUSATES. AFTER USE, THE LUMEN SHOULD AGAIN BE FLUSHED WITH TWICE THE INDICATED LUMEN VOLUME USING NORMAL SALINE BEFORE REESTABLISHING HEPARIN LOCK.¿ EVIDENCE GATHERED UPON REVIEW OF DMR AND PRODUCT LABELING, DOES NOT INDICATE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT THE COOK WAS UNABLE TO ESTABLISH A CAUSE FOR THIS FAILURE. IT IS NOT KNOWN WHAT THE MAINTENANCE ON THE CATHETER WAS. IT¿S POSSIBLE THAT THE CATHETER LUMENS WERE NOT MAINTAINED PROPERLY TO PREVENT THE LUMENS FROM OCCLUDING, BUT COOK CANNOT CONFIRM THIS WITHOUT ADDITIONAL INFORMATION OR DEVICE RETURN. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
IT WAS REPORTED THAT THE CATHETER IN A COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY WAS OCCLUDED. THE VASCULAR TEAM WAS CALLED IN TO ASSESS THE OCCLUDED DEVICE WHILE THE PATIENT WAS IN THE ICU. THE LINE HAD BEEN IN PLACE LESS THAN 24 HOURS. THE USER WAS ABLE TO RESTORE FLOW TO THE LINE, BUT NOTED THE BLUE LUMEN WAS OBSTRUCTED AND HAD BLOOD BACKING UP INTO THE LUMEN. THE DISTAL PORT WAS ABLE TO BE FLUSHED EASILY BUT HAD NO BLOOD RETURN. IT SHOULD ALSO BE NOTED THAT THE FACILITY HAD NOT YET RECEIVED TRAINING ON THE PRODUCT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE. IT IS UNKNOWN IF THE DEVICE HAD TO BE REPLACED. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 487642 | COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY | FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS | FOZ | COOK INC | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |