SYNCHROMED II
Report
- Report Number
- 3004209178-2013-04590
- Event Type
- Injury
- Date Received
- April 3, 2013
- Report Date
- June 6, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID: 8596SC LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6) , EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8709SC LOT# N184773002, IMPLANTED: 2009 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8578 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID: 8590-8 LOT# N113535, IMPLANTED: 2009 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID: 8711 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
SEGMENTS 2, 3, 4, 5, 6 AND PORTIONS OF SEGMENTS 1 AND 7 WERE ASSIGNED TO CATHETER SERIAL # (B)(4). A SIGNIFICANT PORTION OF SEGMENT 1 WAS ASSIGNED TO CATHETER SERIAL (B)(4). THE METAL CATHETER CONNECTOR PORTION AND STRAIN RELIEF SHROUD WAS ASSIGNED TO CATHETER LOT # N113535. A SIGNIFICANT PORTION OF SEGMENT 7 AND A ¿GOOD PORTION¿ OF SEGMENT 8 WAS ASSIGNED TO CATHETER SERIAL # (B)(4). ANALYSIS OF THE RETURNED CATHETERS REVEALED THE FOLLOWING: ANALYSIS OF CATHETER SERIAL # (B)(4) REVEALED A USER RELATED HOLE AND THAT IT WAS INCORRECTLY ASSEMBLED. SEGMENT 3 CONTAINED A MARKING THAT STRONGLY INDICATED A SUTURE HAD BEEN APPLIED DIRECTLY TO THE SURFACE OF THE CATHETER. THIS ANOMALY MAY HAVE POSSIBLY OCCLUDED THE CATHETER AND LED TO THE VOLUME DISCREPANCY NOTED IN THE EVENT INFORMATION. THE SLICE CUTS SEEN IN THE AREA WHERE THIS SUTURE HAD BEEN WERE MOST LIKELY DONE AT EXPLANT WHEN TRYING TO REMOVE THE SUTURE. A HOLE WAS FOUND IN SEGMENT 4. THE NATURE OF THE HOLE INDICATED IT MAY POSSIBLY HAVE BEEN RELATED TO A NEEDLE STICK. THIS ANOMALY WAS NOT RELATED TO MANUFACTURING OF THE CATHETER. A SLICE CUT THE FULL LENGTH OF SEGMENT 6 WAS FOUND. THIS SLICE WAS MOST LIKELY DONE BY THE CUSTOMER AFTER EXPLANT WHILE TRYING TO LOCATE A POSSIBLE OCCLUSION SOURCE. A MARKING ON THE STRAIN RELIEF SHROUD OF SEGMENT 7 INDICATED THAT A SUTURE WAS APPLIED DIRECTLY TO IT. NO OCCLUSIONS WERE SEEN IN ANY OF THE SEGMENTS ASSOCIATED TO THIS CATHETER SERIAL #. ANALYSIS OF CATHETER SERIAL # (B)(4) REVEALED THAT IT WAS INCORRECTLY ASSEMBLED. SEGMENT 1 HAD A LACK OF THE STRAIN RELIEF SHROUD ON THE PROXIMAL SIDE OF THE CATHETER CONNECTOR ATTACHING IT TO THIS CATHETER SERIAL #. A NON-SIGNIFICANT INDENT IN THE SEAL MATERIAL IN THE CUP OF THE SC CONNECTOR WAS NOTED. NO OCCLUSION WAS SEEN IN SEGMENT 1. ANALYSIS OF CATHETER LOT # N113535 REVEALED DRIED BLOOD OR BLOOD OCCLUSION IN THE CATHETER BODY. AN OCCLUSION INSIDE THE METAL PIN OF THE CONNECTOR ON SEGMENT 8 WAS NOTICED. THIS OCCLUSION WAS ABLE TO BE BROKEN LOOSE AND WAS MOST LIKELY RELATED TO DRIED DRUG OR POSSIBLY BLOOD. THE OCCLUSION WAS NOT RELATED TO A MANUFACTURING ISSUE. OTHER ANOMALIES NOTED WITH THIS OVERALL CATHETER RETURN MAY HAVE INTERRUPTED THE FLOW OF DRUG THROUGH THE CATHETER ALLOWING IT TO POSSIBLY CRYSTALLIZE IN THIS METAL PIN. ANALYSIS OF CATHETER SERIAL # (B)(4) REVEALED A HOLE OR TEAR IN THE CATHETER BODY CAUSED BY THE CATHETER CONNECTOR PIN. ANALYSIS ALSO REVEALED A USER RELATED HOLE AND THAT IT WAS INCORRECTLY ASSEMBLED. THE MOST NOTABLE ANOMALY FOR SEGMENT 7 WAS A HOLE IN THE CATHETER WHERE THE METAL PIN OF THE CATHETER CONNECTOR CAME TO AN END. IT WAS ALSO NOTED THAT THERE WAS A LACK OF THE STRAIN RELIEF SHROUD ON THE DISTAL SIDE OF THE CATHETER CONNECTOR. A LACK OF A STRAIN RELIEF SHROUD COULD HAVE BEEN A SIGNIFICANT CONTRIBUTING FACTOR TO THE HOLE THAT WAS SEEN BUT IT WAS UNKNOWN IF THE CATHETER WAS IMPLANTED WITHOUT THE STRAIN RELIEF SHROUD. A MARKING ON THE STRAIN RELIEF SHROUD OF SEGMENT 7 INDICATED THAT A SUTURE WAS APPLIED DIRECTLY TO IT. ON SEGMENT 8, THERE WAS A SET OF HOLES IN THE CATHETER PORTION CORRESPONDING TO WHERE THE BARB ON THE PIN CONNECTOR WAS. ALONG WITH THESE HOLES, TOOL MARKS COULD BE SEEN ON THE CATHETER SEGMENT AND THEREFORE THESE HOLES WERE THOUGHT TO BE CAUSED BY USER ACTIONS, POSSIBLY WHERE A TOOL MAY HAVE BEEN USED TO ASSIST IN SLIDING THE CATHETER ON TO THE PIN OF THE CONNECTOR. ALSO ON SEGMENT 8, ON THE OPPOSITE SIDE OF THE PIN CONNECTOR, A TINY SEGMENT OF CATHETER WAS SEEN. IT APPEARED THAT THIS PORTION OF THE CATHETER WAS TORN AND THIS TEAR WAS THOUGHT TO BE THE RESULT OF EXPLANT DAMAGE.
FINAL DEVICE ANALYSIS OF THE INFUSION PUMP REVEALED THE FOLLOWING: THERE WERE NO ANOMALIES FOUND. FINAL DEVICE ANALYSIS OF THE CATHETER REVEALED THE FOLLOWING: SEGMENT THREE OF THE CATHETER BODY WAS ASSEMBLED INCORRECTLY. SEGMENT FOUR OF THE CATHETER BODY HAD A USER RELATED HOLE.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THE PATIENT WAS DUE FOR A BATTERY REPLACEMENT AND HAD INCREASED SPASTICITY. A VOLUME DISCREPANCY WAS NOTED. THE ACTUAL VOLUME (30 ML) EXCEEDED THE EXPECTED VOLUME (21 ML). THE REASON WAS UNKNOWN. THE CATHETER COULD NOT BE ASPIRATED. UPON FURTHER EXPLORATION, THE SURGEON FOUND A MAJOR OCCLUSION WITHIN THE PROXIMAL CATHETER SEGMENTS. THE PATIENT'S PUMP WAS EXPLANTED AND THEIR CATHETERS WERE EXPLANTED/REVISED. THE PATIENT WAS NOTED TO BE ALIVE AND WITHOUT INJURY. THE MEDICATION USED WITHIN THE SYSTEM WAS GABLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136999 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |