FDA Adverse Event Malfunction Summary report: N

COMPAT

MDR report key: 5406488 · Received February 3, 2016

Report

Report Number
5406488
Event Type
Malfunction
Date Received
February 3, 2016
Date of Event
December 16, 2015
Report Date
December 23, 2015
Manufacturer
NESTLE HEALTHCARE NUTRITION, INC.
Product Code
KNT
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
MA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE PATIENT IS A MALE WHO DEVELOPED AN UNSTAGEABLE PRESSURE ULCER UNDER THE TAPE THAT WAS SECURING HIS FEEDING TUBE. THIS WAS IDENTIFIED AND THE TUBE WAS REPOSITIONED IN HIS RIGHT NARE. THE PATIENT HAS A HISTORY OF CORONARY ARTERY DISEASE AND CARDIAC BY-PASS SURGERY APPROXIMATELY 5 YEARS AGO WITH AN AUTOMATIC IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR PLACEMENT APPROXIMATELY 3 YEARS AGO. HE HAS ATRIAL FIBRILLATION AND IS ON WARFARIN THERAPY, HIS PAST MEDICAL HISTORY INCLUDES CONGESTIVE HEART FAILURE, A STROKE APPROXIMATELY 6 YEARS AGO, DIABETES, HYPERTENSION, AND PERIPHERAL VASCULAR DISEASE WITH MULTIPLE VASCULAR PROCEDURES TO IMPROVE CIRCULATION TO HIS LOWER EXTREMITIES. HE WAS ADMITTED APPROXIMATELY ONE MONTH AGO FOR RIGHT ABOVE THE KNEE AMPUTATION RELATED TO HAVING AN ISCHEMIC RIGHT LEG. PRE-OPERATIVELY, THE PATIENT WAS FOUND TO HAVE OLIGURIC ACUTE KIDNEY INJURY WITH UP TRENDING SERUM CREATININE LEVELS. HE HAD HYPERKALEMIA THAT REQUIRED TREATMENT WITH D50 INTRAVENOUS INFUSION AND INSULIN ADMINISTRATION. HE ALSO DEVELOPED HYPOTENSION WITH SBP (SYSTOLIC BLOOD PRESSURE) 70'S-80'S AND WITH ALTERED MENTAL STATUS. HIS SURGERY WAS DELAYED AND HE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR INITIATION OF VASOPRESSOR THERAPY AND PLACEMENT OF A CENTRAL ACCESS LINE. IN THE ICU, THE PATIENT WAS UNABLE TO TAKE SUFFICIENT ORAL NUTRITION. A SPEECH LANGUAGE PATHOLOGY CONSULTATION IDENTIFIED THE NEED FOR A FEEDING TUBE TO PROTECT HIM FROM ASPIRATING. APPROXIMATELY 6 DAYS POST ADMISSION, THE PATIENT HAD A NASO-GASTRIC FEEDING TUBE PLACED FOR NUTRITION. THE STAFF TRIED TO PLACE A BRIDLE DEVICE TO SECURE THE TUBE, BUT THE PATIENT'S DEVIATED SEPTUM PREVENTED THE BRIDLE FROM BEING PASSED. THE PATIENT PULLED THE TUBE HIMSELF SOON AFTER IT WAS PLACED. THE FOLLOWING DAY, A SMALLER, FEEDING TUBE WAS PLACED. ONCE THE PLACEMENT WAS CONFIRMED, THE PATIENT'S FEEDING BEGUN. THE PATIENT'S TUBE FEEDING RESUMED POST-OPERATIVELY. WHEN THE NURSE WAS PROVIDING ROUTINE CARE AND REPOSITIONING THE TAPE THAT SECURED HIS FEEDING TUBE IN ORDER TO PERFORM CARE TO THE RIGHT NARE, THE NURSE NOTICED A SMALL, 3MM X 3MM UNSTAGEABLE PRESSURE ULCER UNDER THE TAPE THAT SECURED THE FEEDING TUBE TO THE PATIENT'S NOSE. THE TAPE WAS ADJUSTED AWAY FROM THE PRESSURE ULCER AND THEN RE-SECURED. THE FEEDING TUBE REMAINED IN PLACE TO SUPPORT THE PATIENT'S NUTRITION. THE PATIENT TRANSFERRED FROM THE ICU. HIS OVERALL SKIN ASSESSMENT DEMONSTRATED GOOD WOUND HEALING AND NO NEW AREAS OF SKIN BREAKDOWN TO BUTTOCKS OR HEELS. HE DISCHARGED TO AN INPATIENT REHABILITATION FACILITY APPROXIMATELY 4 WEEKS POST ADMISSION WITH HIS FEEDING TUBE IN PLACE FOR NUTRITIONAL SUPPORT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
65444 COMPAT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT NESTLE HEALTHCARE NUTRITION, INC.

Patients

Seq Age Sex Outcome Treatment
1 64 YR Other