CLIC BLOOD CHAMBER
Received Sep 30, 2019 · Event occurred Sep 9, 2019
Report 8030665-2019-01537 · MDR key 9135568
Device
Generic name
Accessories, Blood Circuit, Hemodialysis
Manufacturer
Erika De Reynosa, S.a. De C.v.Catalog number
CL10041021
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
PLANT INVESTIGATION: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER AND THE LOT NUMBER WAS NOT PROVIDED. A MANUFACTURING REVIEW WAS PERFORMED ON THE PRODUCTS SHIPPED TO THE PATIENT FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. THIS REVIEW INCLUDED THE LOT NUMBERS FOR ALL FRESENIUS COMBISET BLOODLINES SHIPPED TO THIS ACCOUNT WITHIN THE SELECTED TIME FRAME. THE ENTIRE SET OF LOTS HAVE BEEN SOLD AND DISTRIBUTED. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE PRODUCT LOTS INVOLVED MET ALL SPECIFICATIONS FOR RELEASE. A REVIEW OF THE DHR DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED.
Description of Event or Problem
A USER FACILITY REPORTED THAT A BLOOD LEAK OCCURRED FROM THE TOP OF AN OPTIFLUX DIALYZER DURING THE PATIENT¿S HEMODIALYSIS TREATMENT. THE BLOOD LEAK MAY HAVE BEEN CAUSED BY THE CLIC DEVICE NOT BEING SCREWED ON PROPERLY, OR PERHAPS CROSS THREADED AND EITHER WAS BUMPED OR HEATED UP AND ¿FELL OFF¿. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THERE WAS BLOOD ON THE DIALYSATE LINES AND NOTED IN THE FLOW INDICATOR. THE PATIENT¿S ESTIMATED BLOOD LOSS WAS 300 CC. THE MACHINE HAD AN ARTERIAL PRESSURE ALARM. THE BLOOD WAS RINSED BACK TO THE PATIENT, AND THE TREATMENT WAS DISCONTINUED. THE TREATMENT WAS NEAR COMPLETION, THEREFORE THE PATIENT NOT STARTED ON ANOTHER MACHINE. THE MACHINE DID NOT MALFUNCTION, AND THE DIALYZER DID NOT CAUSE THE LEAK. THE COMPLAINT DEVICES WERE DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.