CARDIOHELP
Report
- Report Number
- 8010762-2026-0000159
- Event Type
- Malfunction
- Date Received
- April 7, 2026
- Date of Event
- March 17, 2026
- Report Date
- April 30, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- UDI-DI
- 04037691658384
- PMA / PMN Number
- K133598
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A FOLLOW UP WILL SUBMITTED WHEN ADDITIONAL INFORMATION BECOME AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE UNITED KINGDOM MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT, CARDIOHELP¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K133598. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR CARDIOHELP WITH CATALOG NUMBER 701048012.
IT WAS REPORTED THAT THE P ART PRESSURE WAS NOT READING AFTER CONNECTING THE CABLE. FURTHER, THE VENOUS PROBE, WITH 4 LENSES, FAILED TO INITIALIZE. BOTH FAILURES OCCURRED DURING PRIMING.NO HARM TO ANY PERSON HAS BEEN REPORTED. THE RISK FOR HARM OF ANY PERSON FOR THE VENOUS PROBE FAILURE IS REMOTE, NO REPORT IS REQUIRED. A PRESSURE READING ISSUE, CAN LEAD TO A PUMP STOP, IF THE INTERVENTION IS SET BY THE USER, THEREFORE A REPORT IS REQUIRED FOR THE ¿PART NOT READING¿ FAILURE. THUS, ONLY THE PRESSURE READING FAILURE WILL BE INVESTIGATED WITHIN THIS EMDR. COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 863951 | CARDIOHELP | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | CARDIOHELP-I | 04037691658384 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |