MRI I.V. POLE
Report
- Report Number
- 3005053560-2008-00002
- Event Type
- Malfunction
- Date Received
- April 22, 2008
- Date of Event
- March 19, 2008
- Report Date
- April 18, 2008
- Manufacturer
- IRADIMED CORPORATION
- Product Code
- FOX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
DEVICE EVALUATED BY MFR: INITIAL REPORT FROM THE HEALTH CARE PROFESSIONAL INDICATED THAT THE DEVICE (I.V. POLE) WAS EVALUATED BY THE HOSPITAL STAFF. THIS EQUIPMENT WAS RETURNED TO IRADIMED CORPORATION FOR ANALYSIS. INFORMATION WAS OBTAINED FROM CUSTOMER INTERVIEWS AND AN INSPECTION OF THE DAMAGED EQUIPMENT. EVALUATION: METHODS: THE CLINICAL ENGINEER, AND THE MRI TECHNOLOGIST, THE MRI NURSE, AND HER SUPERVISOR WERE INTERVIEWED REGARDING THE EVENT. INFORMATION GATHERED DURING THIS PERIOD WAS USED TO ATTEMPT TO RECONSTRUCT THE EVENT TO ESTABLISH THE POSSIBLE CAUSE(S) OF THE EVENT. RESULTS: ON THE MORNING OF (B) (6), 2008, A PATIENT HAD BEEN SEDATED AND PLACED INSIDE THE MRI MAGNET, AND BEFORE THE SCAN HAD BEGUN, THE PATIENT WAS MOVED OUTSIDE THE MRI MAGNET BY RETRACTING THE PATIENT TROLLEY OF THE MRI SYSTEM. DURING THIS TIME, WE ASSUME SOMETHING SNAGGED THE TOP PORTION OF THE IV POLE AND THE POLE BROKE AT THE UNION IN THE CENTER OF THE POLE. THE IV POLE'S VERTICAL POLE CONSISTS OF TWO 1.25 INCH DIAMETER ALUMINIUM SECTIONS THAT ARE APPROXIMATELY 33 INCHES LONG, AND ARE JOINED TOGETHER WITH A COUPLING CONSISTING OF A 0.25 INCH STAINLESS STEEL THREADED STUD AS ITS CENTER. WHEN PROPERLY ASSEMBLED, THESE TWO POLE SECTIONS ARE TIGHTENED TOGETHER WITH AN END-TO-END UNION, AND SECURED WITH 2 SEPARATED ANTI-ROTATION SET SCREWS TO FORM ONE CONTINUOUS POLE. AT THIS TIME THE UPPER IV POLE SECTION HAD A MRIDIUM 3850 INFUSION PUMP ATTACHED TO IT, AT APPROXIMATELY 12 INCHES ABOVE THE IV POLE UNION. THE MRIDIUM 3850 PUMP WAS IN USE AT THE TIME OF THE EVENT. AT THE TIME THE IV POLE BROKE, THE MRI NURSE WAS BENT OVER BESIDE THE PATIENT TROLLEY, AND THE UPPER PORTION OF THE IV POLE WITH THE MRIDIUM PUMP ATTACHED FELL APPROXIMATELY 12 TO 18 INCHES AND STRUCK HER IN THE BACK. NO SERIOUS INJURY OCCURRED, BUT THE MRI NURSE WENT TO EMPLOYEE HEALTH IN THE HOSPITAL FOR TREATMENT. SHE RECEIVED ICE TREATMENT TO HER BACK, AN ANALGESIC (IBUPROFEN), AND WENT HOME EARLY FOR REST. SUBSEQUENT DISCUSSION WITH THE MRI NURSE INDICATED SHE HAD FULLY RECOVERED WITH NO LASTING INJURY. THE HOSPITAL CONTACTED IRADIMED CORPORATION BY PHONE ON MARCH 18, 2008, AND PRELIMINARY INFORMATION WAS OBTAINED. THE DAMAGED IV POLE WAS MOVED TO THE (B) (4) SHOP, AND WAS MADE AVAILABLE TO IRADIMED CORPORATION. THE DAMAGED COUPLING OF THE IV POLE WAS REMOVED FROM THE POLE SECTIONS AND FORWARDED TO IRADIMED CORPORATION FOR EXAMINATION. PRODUCT EXAMINATION: THE IV POLE'S VERTICAL POLE CONSISTS OF TWO 1.25 INCH DIAMETER ALUMINUM SECTIONS THAT ARE 33 INCHES LONG, AND ARE JOINED TOGETHER WITH A COUPLING SECTION AT THE END OF THE EACH OF THE 2 SECTIONS. THE PAIR OF COUPLINGS FROM THE 1119 IV POLE WERE RETURNED TO IRADIMED CORPORATION ON (B) (6), 2008, AND THE FOLLOWING OBSERVATIONS WERE MADE: THE CENTER 0.25 INCH STAINLESS STEEL THREADED STUD ((B) (4)) HAD BEEN BROKEN IN HALF, WITH A PIECE REMAINING IN EACH IV POLE COUPLING. THE EDGE OF THE STUD SHOWS TEARING OF THE METAL STUD AT ITS PERIMETER INDICATING THE DIRECTION OF THE FORCE APPLIED AT THE FAILURE. EACH OF THE 2 COUPLING SURFACES ((B) (4) AND (B) (4)) SHOWED MARKS WHERE THERE WAS FRICTION OR FORCE APPLIED AT THE POINT OF FAILURE. THESE MARKS WERE AT THE CIRCULAR PERIMETER OF EACH OF THE COUPLINGS, INDICATING A CONTACT POINT WHERE THE 2 IV POLE SECTIONS WERE MAKING CONTACT AT THE TIME OF FAILURE NO OTHER SIMILAR MARKS ARE EVIDENT ON THE SURFACE OF THE CIRCULAR PERIMETER OF THE COUPLINGS. WHEN RE-ASSEMBLED TOGETHER, THE 2 COUPLINGS SHOW A 2.7 MM GAP BETWEEN THE SURFACES OF THE CIRCULAR PERIMETER OF THE COUPLINGS. THIS GAP SUGGESTS THE IV POLE WAS NOT ASSEMBLED PROPERLY, AS WHEN PROPERLY ASSEMBLED, THESE TWO POLE SECTIONS ARE TIGHTENED TOGETHER WITH AN END-TO-END UNION. NO GAP IS PRESENT WHEN THE IV POLE IS PROPERLY ASSEMBLED. INVESTIGATION FINDINGS: THE 1119 IV POLE IS SPECIFIED BY IRADIMED CORPORATION, AND MANUFACTURED BY GCX CORPORATION IN (B) (4). A COPY OF THE ENGINEERING DRAWING OF THE 1119 I.V. POLE (DRAWING NO. (B) (4)) IS ENCLOSED. THE LIKELY CAUSE OF THIS FAILURE IS THE IV POLE WAS NOT PROPERLY ASSEMBLED, AND THE 2 POLE SECTIONS WERE ABLE TO LOOSEN DUE TO THE SET SCREWS NOT BEING TIGHTENED. THIS ALLOWED THE UPPER POLE SECTION TO UNSCREW AND ALLOW THE 2 TO 3 MM GAP TO FORM. WHEN THE IV POLE WAS STRESSED, THE UPPER POLE WAS ABLE TO CANTILEVER, AND WITH THIS LEVER ACTION, CAUSED THE CENTER 0.25 INCH STAINLESS STEEL THREADED STUD TO FAIL. THIS RESULTED IN THE UPPER POLE SECTION SEPARATING FROM THE LOWER POLE SECTION. SECONDLY, WE SUSPECT THAT THIS THREADED STUD HAD BEEN DAMAGED THROUGH AN OVERSTRESS SUSTAINED PRIOR TO THIS ACTUAL FAILURE. PRESENTLY, A TOTAL OF 225 1119 IV POLES OF THIS TYPE HAVE BEEN MANUFACTURED OVER THE LAST 3 YEARS, AND ARE IN USE AROUND THE WORLD. THIS IS THE SECOND FAILURE OF THIS TYPE THAT HAS BEEN REPORTED TO IRADIMED CORPORATION. IN (B) (4) 2008, ANOTHER 1119 IV POLE FAILED DUE TO IMPROPER ASSEMBLY. NO INJURY OR POTENTIAL INJURY RESULTED FROM THIS FAILURE. AT THE CONCLUSION OF THE INVESTIGATION FOR THAT REPORT, TO REDUCE FURTHER THE RISK OF THIS TYPE OF FAILURE, IT WAS RECOMMENDED TO CHANGE THE SIZE OF THE CENTER STAINLESS STEEL THREADED STUD FROM 0.25 INCH (1/4/ INCH) TO 0.3125 INCH (5/16 INCH) TO ALLOW FOR MORE STRENGTH IN THIS UNION. FROM QUALIFICATION TESTING PERFORMED, THE 0.25 INCH (1/4/ INCH) CENTER STAINLESS STEEL THREADED STUD WITHSTOOD A TANGENTIAL LOAD (TO THE LONG AXIS OF THE POLE) OF MORE THAN 75 LBS. AT THE HIGHEST POINT WITHOUT FAILURE. UNDER SIMILAR CONDITIONS, THE 0.3125 INCH (5/16 INCH) CENTER STAINLESS STEEL THREADED STUD CAN WITHSTAND MORE THAN 95 LBS. AT THE HIGHEST POINT WITHOUT FAILURE. CURRENT 1119 IV POLES ARE BEING DELIVERED TO CUSTOMERS WITH THE 0.3125 INCH (5/16 INCH) CENTER STAINLESS STEEL STUD. INVESTIGATION CONCLUSIONS: THE MOST LIKELY CAUSE OF THIS FAILURE IS THE IV POLE WAS NOT PROPERLY ASSEMBLED, AND THE 2 POLE SECTIONS WERE ABLE TO LOOSEN DUE TO THE SET SCREWS NOT BEING TIGHTENED. THIS RESULTED IN THE UPPER POLE SECTION SEPARATING FROM THE LOWER POLE SECTION. THE INSTALLATION GUIDE PROVIDED WITH THE 1119 IV POLE (SEE ATTACHED GXC CORPORATION (B) (4) INSTRUCTIONS) SPECIFICALLY DESCRIBES TO SCREW THE UPPER POLE ONTO THE LOWER POLE, AND TIGHTEN AS MUCH AS POSSIBLE BY HAND. AN ACCOMPANYING ILLUSTRATION AND PHOTOGRAPH DEMONSTRATES HOW THIS SHOULD LOOK. THEN, THE USER IS INSTRUCTED TO TIGHTEN THE SET SCREW IN THE UPPER POLE TO FINALIZE THE ASSEMBLY. ALSO, THE ROUTINE MAINTENANCE REQUIRED INCLUDES PERIODICALLY CHECKING ALL MOUNTING HARDWARE, AND TIGHTENING AS NECESSARY FOR OPTIMAL OPERATION. THIS FAILURE IS CONSIDERED AN UNUSUAL AND ISOLATED INCIDENT. NO OTHER ACTION IS CONSIDERED NECESSARY AT THIS TIME. (B) (4).
DURING THE REMOVAL OF A PATIENT FROM THE MRI MAGNET BORE, THE INFUSION PUMP IV POLE BROKE AT THE UNION IN THE CENTER OF THE POLE. THE UPPER PORTION OF THE POLE WITH THE INFUSION PUMP ATTACHED FELL ATOP THE NURSE'S BACK (WHO WAS BENT OVER AT THE TIME). THE NURSE SUFFERED A CONTUSION TO HER BACK, AND WAS IMMEDIATELY TREATED WITH ICE, A MILD ANALGESIC (IBUPROFEN), AND SUBSEQUENT REST. NO SERIOUS INJURY RESULTED FROM THIS EVENT. THE NURSE HAS RECOVERED FULLY WITHOUT ANY FURTHER TREATMENT. THERE WAS NO PATIENT INVOLVEMENT WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MRI I.V. POLE | I.V. POLE | FOX | IRADIMED CORPORATION | 1119 | 37809 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |