HEART LUNG MACHINE
Report
- Report Number
- 8010762-2026-0000179
- Event Type
- Malfunction
- Date Received
- April 14, 2026
- Date of Event
- April 13, 2026
- Report Date
- May 13, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTQ
- UDI-DI
- 04037691773032
- PMA / PMN Number
- K943803
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS ONGOING. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS EVENT OCCURRED ON THE INDIAN MARKET ON A SIGNIFICANTLY SIMILAR DEVICE TO "VARIO TWIN, HL 20 4-PUMPS", WHICH IS SOLD IN THE US UNDER PREMARKET SUBMISSION NUMBER K943803 FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. FOR D4 UNIQUE IDENTIFIER (UDI)#, PRIMARY DI NUMBER HAS BEEN USED FOR VARIO TWIN, HL 20 4-PUMPS WITH CATALOG NUMBER 701043262, WHICH IS SOLD IN THE US. PROVIDED D4 SERIAL NUMBER AND H4 DEVICE MANUFACTURER DATE CORRESPOND TO DEVICE INVOLVED IN THE EVENT, NOT AVAILABLE IN US.
IT WAS REPORTED THAT A HL 20 PUMP WITH SERIAL NUMBER (B)(6) DISPLAYED THE ERROR MESSAGE "HEAD". THE EVENT OCCURRED DURING A ROUTINE CHECK. NO HARM TO ANY PERSON HAS BEEN REPORTED. ACCORDING TO THE HL20 SERVICE MANUAL THE ERROR "HEAD" INDICATES THAT THE MOTOR TACHO SHOWS A VALUE BUT THE HEAD TACHO SHOWS 0 (ZERO). COMPLAINT ID: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 159748 | HEART LUNG MACHINE | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | DTQ | MAQUET CARDIOPULMONARY GMBH | HL 20 | 04037691773032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |