CITADEL PATIENT CARE SYSTEM
Report
- Report Number
- 3007420694-2018-00011
- Event Type
- Injury
- Date Received
- January 9, 2018
- Date of Event
- September 15, 2017
- Report Date
- February 8, 2018
- Manufacturer
- ARJOHUNTLEIGH POLSKA
- Product Code
- FNL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- RISK MANAGER
Narratives
THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). THIS IS A FOLLOW UP REPORT WITH ADDITIONAL INFORMATION- COVER LETTER. - ATTACHMENT: [COVER LETTER.PDF]
THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 (B)(4). ON 2017-NOV-01 ARJOHUNTLEIGH WAS NOTIFIED ABOUT THE COMPLAINT INVOLVING CITADEL BED EQUIPPED WITH THERAPEUTIC SUPPORT SYSTEM SKIN IQ 365. THE REPORTED INCIDENT TOOK PLACE IN THE (B)(6) HOSPITAL IN THE UNITED STATES. FOLLOWING THE INFORMATION REPORTED BY THE CUSTOMER, THE PATIENT PRESENTED IN INTENSIVE CARE UNIT (ICU) WAS IN RISK OF SKIN BREAKDOWN AND PRESSURE INJURY. AS PER AN ARJOHUNTLEIGH REPRESENTATIVE ON 2017-SEP-15 UPON ORDERING PROCESS, HE WAS INFORMED BY THE CUSTOMER STAFF, THAT THE BED IS NEEDED FOR A RESIDENT WITH AN EXISTING DEEP TISSUE INJURY (DTI). THE RESIDENT INVOLVED IN THE COMPLAINT (FOR WHICH THE BED WAS ORDERED) WAS ADMITTED TO THE HOSPITAL WITHOUT MAKING A NOTE OF DTI IN THE MEDICAL PATIENT'S RECORD BY THE NURSING STAFF. THE PATIENT'S DTI WAS NOT NOTED BY NURSING STAFF UNTIL (B)(6) 2017. FURTHER INFORMATION COLLECTED SHOWED THAT THE STAFF DID NOT DOCUMENT SKIN CHECKS REGULARLY. MOREOVER THEY DID NOT TURN THE PATIENT MANUALLY EVERY TWO HOURS (Q2 TURN). IT WAS STATED WITHIN THE COMPLAINT DESCRIPTION THAT THIS LED TO THE PATIENT'S INJURY. THE CUSTOMER FACILITY STAFF ASSUMED THAT BED EQUIPPED WITH TURNING FEATURE EXCLUDES THE OBLIGATION OF CONDUCTING MANUAL Q2 TURN. ARJOHUNTLEIGH REPRESENTATIVE EDUCATED THE STAFF ON 2017-SEP-15 AND 2017-SEP-18 INFORMING THAT THE Q2 TURN IS NECESSARY AND THAT THE TURNING FEATURE CANNOT BE USED FOR PRESSURE MANAGEMENT. ADDITIONALLY HE ADVISED THAT THE NURSING STAFF SHOULD REFER TO WOCN PREFERENCES WHILE TAKING CARE OF THE PATIENT (WOUND, OSTOMY AND CONTINENCE NURSES SOCIETY IS A PROFESSIONAL COMMUNITY DEDICATED TO ADVANCING THE PRACTICE AND DELIVERY OF EXPERT HEALTHCARE TO INDIVIDUALS WITH WOUND, OSTOMY, AND CONTINENCE CARE NEEDS). THE PATIENT WAS DISCHARGED FROM HOSPITAL WITH NO ADDITIONAL HEALTH CONSEQUENCES REPORTED. ON 2017-NOV-09 THE ARJOHUNTLEIGH REPRESENTATIVE HAD AN INSIDE VISIT IN (B)(6) HOSPITAL TO DISCUSS AN ADVERSE EVENT REPORTED ON 2017-NOV-01. DURING THE VISIT IT WAS CONFIRMED THAT THE CUSTOMER FACILITY HAD NO RECORD OF A DTI UPON PATIENT'S ADMISSION, ALTHOUGH THE ARJOHUNTLEIGH REPRESENTATIVE WAS INFORMED ABOUT IT AT THE TIME THE BED WAS ORDERED. TAKING INTO ACCOUNT ALL THE ABOVE IT REMAINED UNCLEAR NEITHER IF THE PATIENT ACTUALLY HAD DTI UPON ADMISSION NOR IF IT DEVELOPED IN TIME WHILE USING OUR BED/MATTRESS SURFACE. THE ARJOHUNTLEIGH REPRESENTATIVE SUSPECTS THE DTI WAS PRESENT ON ADMISSION AND IT INCREASED IN SIZE DURING THE STAY.THE MEETING ENDED UP WITH THE QUALITY NURSE STATING THAT ARJOHUNTLEIGH PRODUCT WAS NOT DIRECTLY RESPONSIBLE FOR THE DTI OCCURRENCE. IT IS WORTH NOTING THAT PREVENTION AND MANAGEMENT OF PRESSURE ULCERS IS A HOLISTIC PATIENT CARE ACTIVITY. NURSING MANAGEMENT INCLUDES A 24-HOUR INDIVIDUALIZED REPOSITIONING REGIME, EARLY MOBILIZATION, GOOD NUTRITION, MANAGEMENT OF INCONTINENCE AND RESTRICTED TIME SPENT SEATED. A MATTRESS WILL NOT, ON ITS OWN, PREVENT OR TREAT PRESSURE ULCERS, THEREFORE ALL OTHER CARE IS TO BE CONSIDERED AND GIVEN TAKING INTO ACCOUNT INDIVIDUAL PATIENT NEEDS, SUCH AS INDIVIDUALIZED REPOSITIONING REGIME, EARLY MOBILIZATION, GOOD NUTRITION, MANAGEMENT OF INCONTINENCE AND RESTRICTED TIME SPENT SEATED. DUE TO THE FACT THERE WAS NO MALFUNCTION REPORTED IN RELATION TO THE INCIDENT AND THE QUALITY NURSE CONFIRMED THAT CITADEL BED WAS NOT A DIRECT CAUSE OF DTI OCCURRENCE IT CAN BE ASSUMED THAT NURSING STAFF NOT FOLLOWING WOCN PREFERENCES (NO EXACT MEDICAL RECORDS, THE Q2 TURN NOT ISSUED) CONTRIBUTED TO THE INJURY OCCURRENCE/DEVELOPMENT. TO ENSURE THE SAFETY OF OUR PRODUCTS THE INSTRUCTION FOR USE (E.G. 830.238 REV. D) INCLUDES THE FOLLOWING INFORMATION: - INFORMATION : " MONITOR SKIN CONDITIONS REGULARLY AND CONSIDER ADJUNCT OR ALTERNATIVE THERAPIES FOR HIGH ACUITY PATIENTS. GIVE EXTRA ATTENTION TO SKIN OVER ANY RAISED SIDE BOLSTER AND TO ANY OTHER POSSIBLE PRESSURE POINTS AND LOCATIONS WHERE MOISTURE OR INCONTINENCE MAY OCCUR OR COLLECT. EARLY INTERVENTION MAY BE ESSENTIAL TO PREVENTING SKIN BREAKDOWN." WITH AN ABUNDANCE OF CAUTION THE INCREASED SIZE OF THE PATIENT'S DTI AS REPORTED IN THIS EVENT MEETS THE DEFINITION OF A SERIOUS INJURY. DUE TO THAT IT WAS DECIDED TO REPORT THIS EVENT TO COMPETENT AUTHORITIES. AT THE TIME THE INJURY WAS DISCOVERED THE DEVICE WAS BEING USED FOR PATIENT'S HANDLING AND FROM THAT PERSPECTIVE PLAYED A ROLE IN THE INCIDENT. UPON THE CONDUCTED INVESTIGATION DONE BY THE ARJOHUNTLEIGH REPRESENTATIVE, WE WERE ABLE TO DETERMINE THAT NURSING STAFF NOT FOLLOWING WOCN PREFERENCES (NO EXACT MEDICAL RECORDS, THE Q2 TURN NOT ISSUED) CONTRIBUTED TO THE INJURY OCCURRENCE/DEVELOPMENT. THERE WAS NO MALFUNCTION REPORTED IN RELATION TO ARJOHUNTLEIGH DEVICE THEREFORE WE CONCLUDE THAT AT THE TIME THE EVENT OCCURRED THE CITADEL BED MEET ITS MANUFACTURER'S SPECIFICATION.
ON (B)(6) 2017 ARJOHUNTLEIGH WAS NOTIFIED ABOUT AN INCIDENT INVOLVING CITADEL BED. THE REPORTED MALFUNCTION TOOK PLACE IN THE (B)(6) HOSPITAL (PROMEDICA HEALTH) IN THE UNITED STATES. FOLLOWING INFORMATION REPORTED BY THE CUSTOMER FACILITY REPRESENTATIVE ON (B)(6)2017 THE ACCOUNT MANAGER BECAME AWARE THAT THE PATIENT HAD DTI (DEEP TISSUE INJURY). THE NURSE STAFF DID NOT NOTICE DTI INJURY TILL (B)(6) 2017. THE INTERNAL INVESTIGATION CONDUCTED BY FACILITY REVEALED THAT THE NURSE STAFF DID NOT DOCUMENT SKIN CHECKS REGULARLY NOR DID THEY DOCUMENT Q2 TURN (PATIENT'S TURNING EVERY TWO HOURS) WHAT FURTHER LED TO PATIENT'S INJURY. THE STAFF THOUGHT THAT THE BED WOULD DO THIS TURN FOR THEM AND THAT CONTINUED Q2 TURN WAS NOT NECESSARY. ON (B)(6) 2017 AND (B)(6) 2017 THE ACCOUNT MANAGER EDUCATED NURSE STUFF THAT Q2 TURN WAS NECESSARY AND INFORMED NOT USE TURN FEATURE FOR PRESSURE MANAGEMENT. NO ADDITIONAL EVENTS WERE REPORTED IN RELATIONS TO THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 19027 | CITADEL PATIENT CARE SYSTEM | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | ARJOHUNTLEIGH POLSKA | CX811A3F3AMAB0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |