HAMILTON-C6
Report
- Report Number
- 3001421318-2024-01301
- Event Type
- Injury
- Date Received
- May 24, 2024
- Date of Event
- May 17, 2024
- Report Date
- December 6, 2024
- Manufacturer
- HAMILTON MEDICAL AG
- Product Code
- CBK
- UDI-DI
- 07630002808590
- PMA / PMN Number
- K201658
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING.
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: **UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION. UPDATED FIELDS: B4, D1, D4, G6, H2, H4, H5, H11. THIS CASE WAS ASSESSED AS REPORTABLE DUE TO THE MENTIONING THAT THE PATIENT WAS HARMED. AT THE POINT OF THE INITIAL REPORT, THE POTENTIAL INVOLVEMENT OF OUR HAMILTON-C6 WAS CLARIFIED. IT WAS STATED BY OUR PARTNER COMPANY IN GERMANY "THE PATIENT WAS NOT HARMED BY THE C6, BUT ALREADY HAD PULMONARY EDEMA. THIS CAUSED BLOOD TO GET INTO THE PRESSURE TUBES. THE RINSE FLOW BLOCK AND PRESSURE SENSOR ASSEMBLY WERE EXCHANGED AND LIQUID RESIDUE (RED) WAS FOUND INSIDE THE MEASURING TUBE. IN THE LOGFILE, IT WAS FOUND THAT CALIBRATION OF THE FLOW SENSOR FAILED AND IMMEDIATELY THEREAFTER TN (B)(4) IS RECORDED TWICE, A TECHNICAL NOTE INDICATING A RINSE CALIBRATION ERROR, AFTER WHICH THE DEVICE WAS POWERED OFF. AT THIS TIME, MOST LIKELY BLOOD HAD ENTERED INTO RINSEFLOW ASSEMBLY. ON THAT SAME DAY THE DEVICE ALARMED FIVE TIMES WITH "EXTERNAL FLOW SENSOR FAILED", A NOTIFICATION TO CHECK THE FLOW SENSOR FOR EXCESSIVE SECRETIONS. NO TECHNICAL FAULTS WERE FOUND IN THE LOGFILE, ONLY APPLICATION RELATED ALARMS. WITH THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE DEVICE DID NOT MEET ITS SPECIFICATIONS. THE PULMONARY EDEMA WAS THE PATIENTS CONDITION PRIOR TO THE USE OF THE DEVICE, AND THEREFORE, NOT CAUSED BY THE DEVICE. THE NOTIFICATIONS "CHECK FLOW SENSOR TUBING" AND THE RINSE CALIBRATION ERROR (TN (B)(4)) OBSERVED IN THE DEVICE WERE DUE TO THE FACT THAT BLOOD WENT INTO THE PRESSURE TUBES. OUR PARTNER CHECKED AND REPAIRED THE DEVICE, REPLACED THE RINSEFLOW ASSEMBLY AND PRESSURE SENSOR ASSEMBLY AND RELEASED THE DEVICE FOR USE AGAIN.
HAMILTON MEDICAL AG COMES TO THE CONCLUSION: INVESTIGATION ONGOING. HAMILTON MEDICAL AG COMPLAINT NUMBER: (B)(4). FOLLOW-UP 1 - CORRECTED INFORMATION: UDI RELATED DATA QUALITY UPDATES ONLY. FIELD D4 WAS UPDATED WITH FULL UDI INFORMATION.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: BLOOD CONTAMINATION OF PRESSURE SENSOR ASSEMBLY. ORIGINAL: ES KAM ZU EINEM RÜCKSTAU BEI EINEM PATIENT MIT LUNGENÖDEM. DABEI IST BLUT IN DIE DRUCKSCHLÄUCHE GEKOMMEN UND HABEN DEN RINSEFLOWBLOCK UND DAS PRESSURE SENSOR ASSEMBLY MIT BLUT VERUNREINIGT. TRANSLATION: A BACKFLOW OCCURRED IN A PATIENT WITH PULMONARY OEDEMA. BLOOD GOT INTO THE PRESSURE HOSES AND CONTAMINATED THE RINSEFLOW BLOCK AND THE PRESSURE SENSOR ASSEMBLY WITH BLOOD.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: BLOOD CONTAMINATION OF PRESSURE SENSOR ASSEMBLY. ORIGINAL: ES KAM ZU EINEM RÜCKSTAU BEI EINEM PATIENT MIT LUNGENÖDEM. DABEI IST BLUT IN DIE DRUCKSCHLÄUCHE GEKOMMEN UND HABEN DEN RINSEFLOWBLOCK UND DAS PRESSURE SENSOR ASSEMBLY MIT BLUT VERUNREINIGT. TRANSLATION: A BACKFLOW OCCURRED IN A PATIENT WITH PULMONARY OEDEMA. BLOOD GOT INTO THE PRESSURE HOSES AND CONTAMINATED THE RINSEFLOW BLOCK AND THE PRESSURE SENSOR ASSEMBLY WITH BLOOD.
THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: SUMMARY: BLOOD CONTAMINATION OF PRESSURE SENSOR ASSEMBLY. ORIGINAL: ES KAM ZU EINEM RÜCKSTAU BEI EINEM PATIENT MIT LUNGENÖDEM. DABEI IST BLUT IN DIE DRUCKSCHLÄUCHE GEKOMMEN UND HABEN DEN RINSEFLOWBLOCK UND DAS PRESSURE SENSOR ASSEMBLY MIT BLUT VERUNREINIGT. TRANSLATION: A BACKFLOW OCCURRED IN A PATIENT WITH PULMONARY OEDEMA. BLOOD GOT INTO THE PRESSURE HOSES AND CONTAMINATED THE RINSEFLOW BLOCK AND THE PRESSURE SENSOR ASSEMBLY WITH BLOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 664424 | HAMILTON-C6 | HAMILTON-C6 VENTILATOR | CBK | HAMILTON MEDICAL AG | 160021 | 07630002808590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |