IRRIGATION SET, Y-TYPE
Received Apr 25, 2014 · Event occurred Mar 10, 2014
Report 1417592-2014-00041 · MDR key 3788306
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
UNK
- Rupture
Narrative
Description of Event or Problem
FOLLOWING A SURGICAL REPAIR OF A NICKED BLADDER, CONTINUOUS BLADDER IRRIGATION WAS INITIATED. THE BLADDER RUPTURED AGAIN AND THE SURGEON INDICATED HE WAS NOT SURE IF THE CLINICIAN OR THE EQUIPMENT CONTRIBUTED TO THE INCIDENT.
Additional Manufacturer Narrative
FOLLOWING THE REPAIR OF A NICKED BLADDER, THE PT DEVELOPED HEMATURIA. CONTINUOUS BLADDER IRRIGATION WAS INITIATED. WITHIN 10 MINUTES, 3 LITERS OF FLUID HAD BEEN INFUSED INTO THE BLADDER THAT WAS REPORTED TO BE ALREADY WEAKENED. SUBSEQUENTLY, THE BLADDER RUPTURED AND THE PT WAS RETURNED TO THE OPERATING ROOM. FOR SURGICAL REPAIR. THE FACILITY REPORTED THAT THE DRIP CHAMBER FILLED COMPLETELY AND THE NURSE COULD NOT VISUALIZE THE FLOW RATE. THERE WAS NO SAMPLE RETAINED FOR EVALUATION AS THE INCIDENT OCCURRED TWO WEEKS PRIOR AND WAS NOT REPORTED AT THAT TIME. WE HAVE HAD NO OTHER SIMILAR INCIDENTS REPORTED TO US. IT IS NOT KNOWN IF THE IRRIGATION SET WAS CORRECTLY PRIMED WITH FLUID PRIOR TO USE. THE REPORTED AMOUNT OF SOLUTION LEAVING THE IRRIGATION BAG WAS SIGNIFICANT AND WOULD BE VISUALLY APPARENT TO A CLINICIAN. THE ROOT CAUSE APPEARS TO BE CLINICIAN ERROR. HOWEVER, IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILE.