QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8
Report
- Report Number
- 3016746283-2025-00013
- Event Type
- Injury
- Date Received
- October 28, 2025
- Date of Event
- September 30, 2025
- Report Date
- May 11, 2026
- Manufacturer
- SPECTRUM MEDICAL S.R.L.
- Product Code
- DTR
- UDI-DI
- 08051160301171
- PMA / PMN Number
- K223879
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION RELATED TO THE EVENT WILL BE AVAILABLE AFTER COMPLETION OF INVESTIGATION ACTIVITIES, WHICH WOULD BE ADDRESSED IN A FOLLOW-UP REPORT.
INVESTIGATION ACTIVITIES ARE STILL ONGOING IN ORDER TO DEFINE THE ROOT CAUSE OF THE CLAIMED ISSUE. ADDITIONAL INFORMATION WILL BE DISCUSSED IN A SUBSEQUENT FOLLOW-UP COMMUNICATION.
PRELIMINARY ANALYSIS PERFORMED REVEALED A COMBINATION OF TWO HOLES OR ONE HOLE AND ONE DEFECT, IN A SYMMETRICAL POSITION AND IN AN AREA WHERE THE KNURLED PATTERN ANGLE CHANGES. AFTER PRELIMINARY ANALYSIS, THE ROOT CAUSE OF THE PROBLEM HAS NOT YET BEEN IDENTIFIED. ADDITIONAL TESTS ARE ONGOING. CONSIDERING THE POTENTIAL IMPACT ON THE SAFETY OF THE PATIENT, FLUIDIC TESTING CONFIRMED THAT IN CASE OF UNWANTED LOSS OF METAL SHEET INTEGRITY AND UNDER WORST-CASE CONDITIONS, FLOW OCCURS FROM BLOOD TO HTF, ENSURING THAT NO HTF CAN ENTER THE BLOOD COMPARTMENT. ADDITIONAL INFORMATION WILL BE DISCUSSED IN A FOLLOW UP REPORT.
PRELIMINARY FINDINGS AVAILABLE IN CURRENT FOLLOW-UP 002 REPORT: VISUAL INSPECTION AND DEFECT IDENTIFICATION: TWO SYMMETRICAL HOLES WERE FOUND IN THE CENTRAL AREA OF THE DEVICE WHERE THE KNURLED PATTERN CHANGES DIRECTION. SCANNING ELECTRON MICROSCOPY (SEM): SEM IMAGING WAS USED TO CHARACTERIZE THE DIMENSIONS OF THE HOLES AND TO OBTAIN DETAILS OF THE METAL SHEET SURFACE NEAR THE HOLES. FLUID TEST RESULTS: TESTING CONFIRMED THAT EVEN WITH THE HOLES PRESENT, UNDER WORST-CASE CONDITIONS, FLOW OCCURS FROM BLOOD TO HTF, ENSURING THAT NO HTF CAN ENTER THE BLOOD COMPARTMENT. THIS IS DUE TO THE FROSTY DESIGN: HTF IS DRAWN OUT OF THE HEAT EXCHANGER, SO THE PRESSURE INSIDE THE HTF COMPARTMENT IS ALWAYS NEGATIVE, WHILE THE BLOOD COMPARTMENT IS ALWAYS UNDER POSITIVE PRESSURE. AS A RESULT, THE PRESSURE DIFFERENTIAL ACROSS THE METAL SHEET GUARANTEES THAT ONLY BLOOD CAN ENTER THE HTF COMPARTMENT, NOT VICE VERSA. FURTHER TESTING IS ONGOING TO GATHER MORE DETAILS THAT WILL HELP IDENTIFY THE ROOT CAUSE OF THE PROBLEM. THESE TESTS INCLUDE: ANALYSIS OF METAL SHEETS PERFORMED BY AN EXTERNAL LAB; STUDY OF CURRENT/VOLTAGE VERSUS HOLE FORMATION. A FINAL AND COMPLETE REPORT WILL BE RELEASED WHEN ALL THE RESULTS WILL BE AVAILABLE.
CCPS DEPRIMED HX AND COULD SEE VISIBLE BLOOD LEAK. HX WENT "DARK" AFTER 7 MINUTES ON CPB. CCPS SWITCHED SYSTEMIC HEATER COOLER TO ECMO CARDIOQUIP FOR REMAINDER OF CASE. NO CHANGES WERE NOTED TO PRIMING PROTOCOL PER CHIEF.
CCPS DEPRIMED HX AND COULD SEE VISIBLE BLOOD LEAK. HX WENT "DARK" AFTER 7 MINUTES ON CPB. CCPS SWITCHED SYSTEMIC HEATER COOLER TO ECMO CARDIOQUIP FOR REMAINDER OF CASE. NO CHANGES WERE NOTED TO PRIMING PROTOCOL PER CHIEF.
CCPS DEPRIMED HX AND COULD SEE VISIBLE BLOOD LEAK. HX WENT "DARK" AFTER 7 MINUTES ON CPB. CCPS SWITCHED SYSTEMIC HEATER COOLER TO ECMO CARDIOQUIP FOR REMAINDER OF CASE. NO CHANGES WERE NOTED TO PRIMING PROTOCOL PER CHIEF.
CCPS DEPRIMED HX AND COULD SEE VISIBLE BLOOD LEAK. HX WENT "DARK" AFTER 7 MINUTES ON CPB. CCPS SWITCHED SYSTEMIC HEATER COOLER TO ECMO CARDIOQUIP FOR REMAINDER OF CASE. NO CHANGES WERE NOTED TO PRIMING PROTOCOL PER CHIEF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 390761 | QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8 | STANDARD HEAT EXCHANGER | DTR | SPECTRUM MEDICAL S.R.L. | HX55W-S0 | G002173 | 08051160301171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |