FDA Adverse Event
Malfunction
Summary report: N
QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8
MDR report key: 23643758
·
Received November 25, 2025
Report
- Report Number
- 3016746283-2025-00021
- Event Type
- Malfunction
- Date Received
- November 25, 2025
- Date of Event
- October 27, 2025
- Report Date
- February 13, 2026
- Manufacturer
- SPECTRUM MEDICAL S.R.L.
- Product Code
- DTR
- UDI-DI
- 08051160301171
- PMA / PMN Number
- K223879
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION CONCLUSION ARE SUMMARIZED IN THE ENGINEERING REPORT 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 |
|---|---|---|---|---|---|---|---|
| 2825900 | QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8 | STANDARD HEAT EXCHANGER | DTR | SPECTRUM MEDICAL S.R.L. | HX55W-S0 | G002123 | 08051160301171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |