Description of Event or Problem · 1
DURING A SURGICAL PROCEDURE TO REPAIR A MENISCUS TEAR OF THE RIGHT KNEE, THE ARTHROSCOPIC PUMP ALARMS DID NOT ACTIVATE, FAILING TO ALERT THE PHYSICIAN TO INCREASED PRESURE IN THE ANTERIOR THIGH. A RUPTURE OF THE SUPRA-PATELLA POUCH ALLOWED EXTRAVASATION OF FLUID INTO THE SUBMUSCULAR POTENTIAL SPACE CREATING A COMPARTMENT SYNDROME OF THE RIGHT THIGH. AN ANTERIOR THIGH COMJPARTMENT RELAEASE WAS PERFORMED. THE PHYSICIAN ELECTED TO DELAY THE PLANNED ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. IT WAS DONE 4/13/92. THE PATIENT WAS DISMISSED FROM THE HOSPITAL ON 4/15/92. THE ARTHROSCOPIC PUMP WAS PERFORMANCE TESTED BY THE FACILITY'S BIO-MEDICAL ENGINEERING DEPARTMENT. THE EVENT COULD NOT BE DUPLICATEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-MAR-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED, NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION, NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.