FDA Adverse Event
Malfunction
Summary report: N
QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8 W
MDR report key: 23616348
·
Received November 21, 2025
Report
- Report Number
- 3016746283-2025-00019
- Event Type
- Malfunction
- Date Received
- November 21, 2025
- Date of Event
- October 27, 2025
- Report Date
- February 13, 2026
- Manufacturer
- SPECTRUM MEDICAL S.R.L.
- Product Code
- DTR
- UDI-DI
- 18051160302205
- PMA / PMN Number
- K223879
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DETAILED INVESTIGATION REPORT WITH CORRESPONDING CONCLUSIONS IS ATTACHED (REFER TO (B)(4).
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION RELATED TO THE EVENT WILL BE AVAILABLE AFTER COMPLETION OF INVESTIGATION ACTIVITIES, WHICH WOULD BE ADDRESSED IN A FOLLOW-UP REPORT.
Description of Event or Problem · 0
USER REPORTED SIGNS OF DAMAGE TO THE STERILE PRIMARY PACKAGING (BLISTER) BEFORE USE. NO PATIENT WAS INVOLVED.
Description of Event or Problem · 0
USER REPORTED SIGNS OF DAMAGE TO THE STERILE PRIMARY PACKAGING (BLISTER) BEFORE USE. NO PATIENT WAS INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2077252 | QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8 W | STANDARD HEAT EXCHANGER | DTR | SPECTRUM MEDICAL S.R.L. | HX55V-S0W | H000450 | 18051160302205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |