CAREFUSION
Report
- Report Number
- 2021710-2012-00077
- Event Type
- Other
- Date Received
- August 29, 2012
- Date of Event
- August 2, 2012
- Report Date
- August 2, 2012
- Manufacturer
- CAREFUSION
- Product Code
- BZD
- PMA / PMN Number
- K974303
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MFR. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY A CAREFUSION PRODUCT MANAGER IN RESPONSE TO A PHONE CONVERSATIONS WITH CAREFUSION REGIONAL SALES MANAGER AND A USER FACILITY REP. (B)(4). CAREFUSION DID NOT REQUEST THE RETURN OF THE USED PT CIRCUIT, GENERATOR AND NASAL PRONGS FOR EVAL. THE CAREFUSION INFANT FLOW LP SERIES NCPAP SYSTEM (GENERATOR, MASK, PRONGS, BONNET AND HEADGEAR) ARE THE NEXT GENERATION OF PT INTERFACE DEVICES FROM CAREFUSION. THE DISTRIBUTOR SWITCHED THE USER FACILITY OVER TO THE CAREFUSION INFANT FLOW LP SERIES NCPAP SYSTEM W/O PROVIDING ANY TRAINING ON THE CORRECT FIXATION TECHNIQUES FOR THE LP SERIES NCPAP GENERATOR, MASK, PRONGS, BONNET AND HEADGEAR. AS SUCH THE LACK OF EXPERIENCE WITH THESE DEVICES MAY HAVE BEEN THE UNDERLYING CAUSE OF THE REPORTED EVENT. CAREFUSION FOLLOWED UP WITH THE USER FACILITY AND WAS INFORMED THAT THE PT DID NOT REQUIRE SURGERY AS THE NASAL INJURY HEALED WITH APPROPRIATE WOUND CARE. THE USER FACILITY HAS STATED THAT THEY WOULD LIKE TO GO BACK TO USING THE AIRLIFE NCPAP SYSTEM (GENERATOR, MASK, PRONGS, BONNET AND HEADGEAR). THUS CAREFUSION HAS MADE ARRANGEMENTS WITH THE LOCAL DISTRIBUTOR TO STOCK INVENTORY OF THE AIRLIFE NCPAP SYSTEM FOR THE USER FACILITY. THE CAREFUSION INFANT FLOW LP NCPAP SYSTEM INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING INFO; WARNING: USE THIS PRODUCT ONLY AS DIRECTED IN THE PRODUCT LITERATURE TO REDUCE THE RISK OF NASAL IRRITATION, SEPTAL DISTORTION, SKIN IRRITATION AND PRESSURE NECROSIS. TO BE USED BY A TRAINED PRACTITIONER, UNDER THE DIRECT SUPERVISION OF A QUALIFIED PHYSICIAN. USE OF THE INFANT FLOW LP GENERATOR VARIABLE FLOW NCPAP DRIVERS. DO NOT OVER TIGHTEN THE FIXATION STRAPS. NOTES: SELECT THE APPROPRIATE SIZE NASAL MASK TO MINIMIZE LEAKS AND DEAD SPACE. SELECT THE APPROPRIATE SIZE NASAL PRONGS; IF BETWEEN SIZES, SELECT THE LARGER SIZE. APPLICATION OF AN INCORRECTLY SIZED PRONG, MASK, BONNET, OR HEADGEAR WILL AFFECT THE STABILITY OF THE GENERATOR. CONSIDER ALTERNATING THE USE OF PRONG AND MASK INTERFACES AT SET INTERVALS TO CHANGE PRESSURE POINTS ON THE INFANTS FACE. CONTINUOUSLY MONITOR THE PT'S RESPIRATORY STATUS, (RESPIRATORY RATE, HEART RATE, OXYGEN SATURATION). COVER BOTH EARS EVENLY; ENSURE THE EARS ARE NOT FOLDED. ADJUST THE STRAPS TO STABILIZE THE GENERATOR AND MAINTAIN A SEAL AT THE NOSE USING THE LEAST TENSION POSSIBLE. RECOMMENDED HUMIDIFICATION BE USED WITH NCPAP SYSTEMS. THE INFANT FLOW LP HAS A BUILT IN "POP-OFF", WHICH IS ACTIVATED IF THE DRIVE PRESSURE EXCEEDS 60 CM H2O. FINAL CHECK AND ROUTINE INSPECTION. INSPECT THE SYSTEM AFTER SET-UP AND ROUTINELY EVERY 3 TO 4 HRS TO... ENSURE THE PT IS RECEIVING THE PRESCRIBED LEVEL OF CPAP. ENSURE THE GENERATOR IS STABLE, SECURE, AND NOT PULLING UPWARD ON THE NOSE. CHECK FOR DEFORMATION OR IRRITATION TO THE NOSE OR SURROUNDING TISSUE. ENSURE THE PT'S SEPTUM IS CLEARLY VISIBLE WHEN USING PRONGS. ENSURE THAT THE PT'S EYES ARE CLEARLY VISIBLE AND THAT THE NARES ARE NOT BLOCKED, WHEN USING MASKS. INSPECT THE FIXATION DEVICE AND STRAPS FOR PROPER TENSION AND ADJUST AS NEEDED TO MAINTAIN A PROPER FIT. MONITOR THE PT FOR GASTRIC INSUFFLATION AND ABDOMINAL DISTENSION. MONITOR FOR EXCESSIVE CONDENSATION IN CIRCUIT AND GENERATOR.
THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED ON (B)(6) 2012 BY A CAREFUSION PRODUCT MANAGER IN RESPONSE TO A PHONE CONVERSATION WITH A CAREFUSION REGIONAL SALES MANAGER. "PART NUMBER - (B)(4) INFANT FLOW LP COMBO KIT (RT-132 CIRCUITS AND (B)(4) GENERATOR) INTERFACE USED (B)(4) (INFANT FLOW SMALL MASK AND SMALL PRONGS): "I RECEIVED A CALL FROM [NAME REMOVED] (REGIONAL SALES MANAGER) THAT CUSTOMER HAD MADE COMPLAINT STATING THAT THEY WERE HAVING PROBLEMS WITH THE NASAL CPAP SYSTEM. ONE INFANT HAD NASAL INJURY THAT WOULD REQUIRED SURGICAL REPAIR." THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED ON (B)(6) 2012 BY A CAREFUSION PRODUCT MANAGER IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. "I CALLED [NAME REMOVED] ((B)(6)) FOR ADD'L INFO. [INITIALS REMOVED] WAS SWITCHED OVER TO THE INFANT FLOW LP PRODUCT LINE SEVERAL MONTHS AGO BY THE [DISTRIBUTOR'S NAME REMOVED] DISTRIBUTION CENTER AND WERE TOLD THAT THE AIRLIFE NCPAP SYSTEM ((B)(4)) THEY WERE USING HAD BEEN OBSOLETED. THEY REC'D NO TRAINING ON THE NEW SYSTEMS. EVER SINCE SWITCHING THEY HAVE HAD MULTIPLE ISSUES WITH THE LP SYSTEM. THEY DID NOT EXPERIENCE THESE PROBLEMS WITH THE AIRLIFE SYSTEM: IF THE HEADGEAR STRAP IS PUT ON TOO TIGHT CAUSES SWELLING TO OCCUR AROUND THE EYES, IF THEY LOOSEN THE HEADGEAR THAN THE PRONGS POP OUT OF THE NOSE AND KINK. IF YOU PULL THE STRAPS TOO TIGHT IN ORDER TO KEEP THE PRONGS IN THE NOSE, THEN THE SEPTUM BECOMES PINCHED BY THE BASE OF THE PRONGS. THE PRONGS ARE TOO FLIMSY AND EASILY KINK AND BEND. THE MASK ARE FLIMSY AND DON'T HOLD THEIR SHAPE. THE STAFF HAVE BEEN STRUGGLING TO MAKE THE SYSTEM WORK AND IT DOESN'T. THEY ARE LOOKING AT MOVING TO OTHER CPAP DELIVERY OPTIONS. THE MOST RECENT INCIDENT WHICH INVOLVED A NASAL INJURY. THEY HAVE (B)(6) TWINS. ONE OF THE TWINS HAD NASAL DAMAGE TO THE SEPTAL AREA. SHE WAS NOT ABLE TO PROVIDE WITH INFO TO THE DEGREE OF SKIN DAMAGE OR VERIFY IF IT WOULD REQUIRE SURGICAL RECONSTRUCTION. SHE STATED THAT AS OF TODAY THERE HAD NOT BEEN A SURGICAL REPAIR DONE. I HAVE REQUESTED THAT CFN SENDS IN A CLINICAL OR SALES REP TO F/U AND PROVIDE ADD'L TRAINING."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAREFUSION | VENTILATOR, NON-CONTINUOUS (RESPIRATOR)/BZD | BZD | CAREFUSION | NASAL MASK/PRONGS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ASKU |