MODEL 3000 - 30ML VOLUME, HIG
Report
- Report Number
- 1226348-2018-00638
- Event Type
- Injury
- Date Received
- July 9, 2018
- Date of Event
- June 5, 2018
- Report Date
- June 11, 2018
- Manufacturer
- CODMAN AND SHURTLEFF, INC
- Product Code
- LKK
- UDI-DI
- 10886704043591
- PMA / PMN Number
- P890055
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PRODUCT COMPLAINT #: (B)(4). THIS FOLLOW-UP MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #1226348-2018-00638. THIS MDR IS BEING SUBMITTED TO REPORT A CHANGE, ALONG WITH ADDITIONAL INFORMATION RECEIVED ON AUGUST 20, 2018. (B)(4). ADDITIONAL INFORMATION RECEIVED ON AUGUST 20, 2018: THE CATHETER WAS IN PLACE FROM TIME OF SURGERY, (B)(6) 2015 UNTIL IT WAS REMOVED FROM THE PATIENT ON (B)(6) 2018. THE PATIENT IS CURRENTLY BEING TREATED FOR RECURRENT INFECTIONS, BUT IS STABLE.
PRODUCT COMPLAINT # (B)(4). THIS FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #1226348-2018-00638. CONCLUSION: CODMAN PUMP SN (B)(4) WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION SHOWED SCRATCHES ON THE EXTERIOR METAL SURFACE OF THE PUMP NEAR THE SEPTUM THAT APPEAR TO BE CONSISTENT WITH NEEDLE MARKINGS. THE SEPTUM FELT NORMAL WITH SEVERAL PUNCTURE MARKS AND ONE LARGER PUNCTURE MARK IN THE CENTER OF THE SEPTUM CONSISTENT WITH NEEDLE PENETRATION. THE PUMP HAD A 3.75¿ WHITE CATHETER ATTACHED TO THE PUMP AND TIED WITH SUTURE .5¿ FROM THE DISTAL END. A 13.5¿ WHITE CATHETER WAS INCLUDED WITH THE PUMP BUT NOT ATTACHED. IT WAS TIED WITH SUTURE AT 2¿ FROM ONE END WITH APPROX. 2.5¿ OF DARK DISCOLORATION ON THE INTERIOR OF THE CATHETER AT 1¿ FROM THAT END. IT WAS ALSO TIED WITH SUTURE AT THE DISTAL END WITH DARK YELLOW DISCOLORATION ON THE EXTERIOR OF THE CATHETER. THERE WAS ALSO A .5¿ AREA OF DARK DISCOLORATION ON THE INTERIOR OF THE CATHETER AT 3.5¿ FROM THE DISTAL END. APPROXIMATELY (4MLS) OF CLEAR FLUID WITH NO PARTICLES AND 32MLS OF AIR WERE EMPTIED FROM THE RESERVOIR. THE BOLUS PATHWAY AND CATHETER WERE FLUSHED WITH NO RESISTANCE. A LIGHT BLUE LIQUID CONSISTENT WITH DYE TESTING WITH NO PARTICLES WAS COLLECTED. NO LEAKS FROM THE SEPTUM OR CATHETER WHEN FLUSHING WITH PRESSURIZING. THE 13.5¿ CATHETER THAT WAS NOT ATTACHED TO THE PUMP COULD FLUSH WITH NO RESISTANCE, BLUE DYE AND DARK PARTICULATES WERE FLUSHED FROM THE CATHETER. THE RESERVOIR WAS FILLED WITH 30MLS OF BACTERIOSTATIC WATER AND PLACED IN A 37-DEGREE CELSIUS WATER BATH FOR FLOW TESTING. THE PUMP FLOWED AN AVERAGE OF 1.95 ML/DAY, 102.63% OF MANUFACTURED FLOW RATE OF 1.9 MLS/DAY WHICH IS WITHIN THE SPECIFIED PERCENTAGE OF 85.1% - 114.9%. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NON-CONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR.
(B)(4). THIS FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #1226348-2018-00638. BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; HOWEVER A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
PRODUCT COMPLAINT # (B)(4). THIS FOLLOW-UP MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #1226348-2018-00638. THIS MDR IS BEING SUBMITTED TO CAPTURE THE DEVICE RECEIPT DATE OF JULY 04, 2018, ALONG WITH THE ADDITIONAL INFORMATION RECEIVED ON JULY 04, 2018. ADDITIONAL INFORMATION RECEIVED ON JULY 04, 2018: THE CATHETER HAD BEEN PLACED IN THE GASTRODUODENAL ARTERY. IT WAS CONFIRMED THAT THE ARTERY WAS PERFORATED AND REPAIRED USING 2-0 SILK TO TRANSFIX THE BASE OF THE ARTERY. THE PATIENT DID NOT EXPERIENCE SIGNIFICANT BLEEDING, NOR DID THE PATIENT RECEIVE A BLOOD TRANSFUSION. REPORTEDLY, THE CATHETER DID NOT DETACH FROM THE PUMP. THE PATIENT DID NOT HAVE A KNOWN HISTORY OF DUODENAL ULCER. THERE WAS NO EVIDENCE OF INFECTION RELATED TO THE ULCER PERFORATION. THE PUMP WAS IMPLANTED ON SEPTEMBER 21, 2015. IMAGING WAS DONE AND THE FACILITY MAY BE ABLE TO PROVIDE IT FOR FURTHER ANALYSIS.
(B)(4). THIS INITIAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #1226348-2018-00638. THE PRODUCT HAS BEEN FORWARDED TO CODMAN FOR EVALUATION AND TESTING, HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A CODMAN 3000 (AP03000H/15041) WAS EXPLANTED FROM A PATIENT ON (B)(6) 2018 BECAUSE THE PATIENT'S CATHETER HAD MIGRATED CAUSING A PERFORATION OF A DUODENAL ULCER ASSOCIATED WITH THE HEPATIC ARTERY INFUSION PUMP. THE CATHETER MIGRATION WAS DISCOVERED VIA CT/EGD SCAN. THE PATIENT PRESENTED WITH POST-PRANDIAL ABDOMINAL DISCOMFORT, NAUSEA, VOMITING, AND WEIGHT LOSS. THE DRUG BEING USED IN THE PATIENT WHEN IT WAS REMOVED WAS FUDR. THERE WAS NO DAMAGE NOTED TO THE PUMP UPON REMOVAL FROM THE PATIENT. A NEW PUMP WAS NOT IMPLANTED IN THIS PATIENT. THE PERFORATION WAS TREATED BY PRIMARY REPAIR AND GRAHAM PATCH. THE PATIENT WAS REPORTED TO BE STABLE AND AN INPATIENT POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 513570 | MODEL 3000 - 30ML VOLUME, HIG | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | CODMAN AND SHURTLEFF, INC | 666163 | 10886704043591 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |