FDA Adverse Event
Malfunction
Summary report: N
SURGE CARDIOVASCULAR
MDR report key: 22877033
·
Received August 22, 2025
Report
- Report Number
- 3017540705-2025-00002
- Event Type
- Malfunction
- Date Received
- August 22, 2025
- Date of Event
- July 24, 2025
- Report Date
- August 22, 2025
- Manufacturer
- MED MICHIGAN HOLDINGS, LLC / SURGE CARDIOVASCULAR
- Product Code
- DWF
- UDI-DI
- 00817278010347
- PMA / PMN Number
- K964200
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
CUSTOMER REPORTED CERTAIN PORTS ARE NOT FLOWING IN MULTIPLE PERFUSION SET. NO INJURY OR DEATH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2456860 | SURGE CARDIOVASCULAR | MULTIPLE PERFUSION SET | DWF | MED MICHIGAN HOLDINGS, LLC / SURGE CARDIOVASCULAR | PER-1400S | 09033-022425 | 00817278010347 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |