SNAP¿ THERAPY SYSTEM

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED BOWEL DAMAGE IS RELATED TO THE SNAP¿ THERAPY SYSTEM. THE PHYSICIAN REPORTED THE CASUAL RELATION WITH THE HEALTH DAMAGE AND NOT USING THE NON-ADHERING SKIN PROTECTIVE WOUND DRESSING CONCURRENTLY WHEN SWITCHING TO SNAP¿ THERAPY SYSTEM WAS NOT CONFIRMED IN THE HOSPITAL. THE PATIENT UNDERWENT EMERGENCY SURGERY FOR STRANGULATED ILEUS AND SUBSEQUENTLY EXPERIENCED WOUND DEHISCENCE WHICH EVIDENCED WEAKENED TISSUE. UPON SNAP¿ THERAPY SYSTEM APPLICATION, THE PHYSICIAN DID NOT RECOGNIZE THE EXPOSED INTESTINE, AND THE FOLLOWING MORNING THE PATIENT WAS URGENTLY RE-ADMITTED TO THE HOSPITAL. THE PATIENT WAS SUBSEQUENTLY DISCHARGED HOME THE SAME DAY WITH NO INDICATION ANY MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED. THE SAME DAY THE PATIENT WAS DISCHARGED FROM THE URGENT READMISSION, THE PATIENT WAS AGAIN EMERGENTLY RE-ADMITTED TO THE HOSPITAL AND RECEIVED COMPRESSION THERAPY. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: CONTRAINDICATIONS DO NOT PLACE THE SNAP¿ THERAPY SYSTEM OVER: NECROTIC TISSUE SUCH AS ESCHAR OR ADHERENT SLOUGH, EXPOSED BLOOD VESSELS, ANATOMIC SITES, ORGANS, TENDONS OR NERVES, FISTULAS. PHYSICIAN INSTRUCTIONS IT IS IMPORTANT TO CAREFULLY EVALUATE THE WOUND AND PATIENT, TO ENSURE THAT THE INDICATIONS FOR USE ARE MET.

Description of Event or Problem

ON FEB 08 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PHYSICIAN AND WOUND CARE NURSE: ON (B)(6) 2018, THE PATIENT WAS PLACED ON SNAP¿ THERAPY SYSTEM. A ¿FOAM NOT COVERED WITH A NON-ADHESIVE DRESSING WAS FILLED IN THE WOUND.¿ IT WAS NOTED THAT ¿THE DOCTOR DID NOT RECOGNIZE THE EXPOSURE OF THE INTESTINE.¿ ON (B)(6) 2018, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, AND THAT EVENING THE COLOR OF THE EXUDATE ALLEGEDLY CHANGED FROM YELLOW TO GREEN WITH THE AMOUNT OF EXUDATE INCREASED TO 30 ML. THE PATIENT WAS URGENTLY RE-ADMITTED TO THE HOSPITAL. ON FEB 08 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE WOUND CARE NURSE: ON (B)(6) 2018, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND DURING THE NIGHT, THE AMOUNT OF EXUDATE INCREASED, AND INTESTINAL FLUID WAS ALLEGEDLY COLLECTED. THE PATIENT WAS EMERGENTLY RE-ADMITTED TO THE HOSPITAL AND RECEIVED COMPRESSION THERAPY. ON FEB 21 2018, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PHYSICIAN: FROM THE INITIAL APPLICATION OF V.A.C.© THERAPY, THE PHYSICIAN CONFIRMED NO FISTULA WAS PRESENT. THE NEGATIVE PRESSURE WITH THE FOAM DRESSING WAS APPLIED OVER THE WEAKENED NECROTIC TISSUE AND THE BOWEL ADHERED TO THE FASCIA WHICH ALLEGEDLY DAMAGED THE BOWEL. THE CASUAL RELATION WITH THE HEALTH DAMAGE AND NOT USING THE NON-ADHERING SKIN PROTECTIVE WOUND DRESSING CONCURRENTLY WHEN SWITCHING TO SNAP¿ THERAPY SYSTEM WAS NOT CONFIRMED IN THE HOSPITAL. ON FEB 26 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PHYSICIAN: THE WOUND HAS A POCKET, NO TUNNEL NOTED. THE POCKET HAD IMPROVED BUT THE POCKET WAS NOT COMPLETELY CLOSED PRIOR TO SNAP¿ THERAPY SYSTEM PLACEMENT. THE DOCTOR BELIEVED THE GRANULATION IMPROVEMENT IS BETTER WHEN USING ONLY FOAM. A NON-ADHESIVE DRESSING WAS NOT USED WITH SNAP¿ THERAPY SYSTEM. COMPRESSION THERAPY WAS THE ONLY MEDICAL INTERVENTION USED FOR THE ALLEGED BOWEL DAMAGE. A DEVICE HISTORY REVIEW WAS PERFORMED ON MAR 05 2018 FOR LOT 3163874 AND DETERMINED THAT THERE WERE NO ISSUES DURING THE MANUFACTURING OF THIS UNIT THAT WOULD HAVE LED TO THE REPORTED EVENT. A DEVICE HISTORY REVIEW FOR LOT L1506090 IS CURRENTLY PENDING COMPLETION. ON MAR 06 2018, THE SNAP¿ 125 MMHG CARTRIDGE FROM THE SAME LOT 3163874 WAS TESTED BY KCI QUALITY ENGINEERING AND THE DEVICE FUNCTIONED PROPERLY AND MAINTAINED PRESSURE.

Description of Event or Problem

A DEVICE HISTORY REVIEW WAS PERFORMED ON MAR 09 2018 FOR LOT L1506090 AND DETERMINED THAT THERE WERE NO ISSUES DURING THE MANUFACTURING OF THIS UNIT THAT WOULD HAVE LED TO THE REPORTED EVENT.

Additional Manufacturer Narrative

BASED ON THE ADDITIONAL INFORMATION OBTAINED FROM THE DEVICE HISTORY REVIEW OF LOT NUMBER L1506090, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ALLEGED BOWEL DAMAGE IS RELATED TO THE SNAP¿ THERAPY SYSTEM. THIS REPORT IS BEING FILED DUE TO POSSIBLE USE ERROR.