QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8
Report
- Report Number
- 3016746283-2025-00022
- Event Type
- Injury
- Date Received
- December 9, 2025
- Date of Event
- November 10, 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
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRELIMINARY FINDINGS AVAILABLE IN CURRENT FOLLOW-UP 001 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.
ADDITIONAL INFORMATION RELATED TO THE EVENT WILL BE AVAILABLE AFTER COMPLETION OF INVESTIGATION ACTIVITIES, WHICH WOULD BE ADDRESSED IN A FOLLOW-UP REPORT.
PRELIMINARY FINDINGS CONFIRMED THE PRESENCE OF ONE HOLE AND ONE DEFECT IN A SYMMETRICAL POSITION AND IN AN AREA WHERE THE KNURLED PATTERN ANGLE CHANGES. AT CURRENT STAGE OF INVESTIGATION ACTIVITIES, THE ROOT CAUSE OF THE PROBLEM HAS NOT YET IDENTIFIED. ADDITIONAL TEST ARE ONGOING. THESE WILL BE DISCUSSED IN A FURTHER FOLLOW-UP REPORT.
USER REPORTED THAT WHILE BREAKING DOWN THE PUMP FROM THE CASE, IT WAS NOTICED THAT THE SYSTEMIC HEAT EXCHANGER WAS "PURPLE" IN COLOUR INSTEAD OF THE USUAL BLUE. USER WAS WEARY THAT THERE COULD HAVE BEEN A BLOOD LEAK INTO THE HEAT EXCHANGER. NO CLINICAL CONSEQUENCES OCCURRED FOR THE PATIENT.
USER REPORTED THAT WHILE BREAKING DOWN THE PUMP FROM THE CASE, IT WAS NOTICED THAT THE SYSTEMIC HEAT EXCHANGER WAS "PURPLE" IN COLOUR INSTEAD OF THE USUAL BLUE. USER WAS WEARY THAT THERE COULD HAVE BEEN A BLOOD LEAK INTO THE HEAT EXCHANGER. NO CLINICAL CONSEQUENCES OCCURRED FOR THE PATIENT.
USER REPORTED THAT WHILE BREAKING DOWN THE PUMP FROM THE CASE, IT WAS NOTICED THAT THE SYSTEMIC HEAT EXCHANGER WAS "PURPLE" IN COLOUR INSTEAD OF THE USUAL BLUE. USER WAS WEARY THAT THERE COULD HAVE BEEN A BLOOD LEAK INTO THE HEAT EXCHANGER. NO CLINICAL CONSEQUENCES OCCURRED FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 348191 | QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8 | STANDARD HEAT EXCHANGER | DTR | SPECTRUM MEDICAL S.R.L. | HX55W-S0 | H000059 | 08051160301171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |