TUBING SET
Report
- Report Number
- 8010762-2026-0000204
- Event Type
- Malfunction
- Date Received
- May 4, 2026
- Date of Event
- April 24, 2026
- Report Date
- May 26, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTZ
- PMA / PMN Number
- K112360
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE HONG KONG MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "HLS SET¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K112360. 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, NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THE LOT NUMBER OF THE AFFECTED SET WAS NOT PROVIDED YET. THEREFORE IT IS NOT YET POSSIBLE TO IDENTIFY THE SET LOT NUMBER OF THE DEVICE IN QUESTION AND THEREFORE ITS UDI NUMBER.
THE EVENT OCCURRED IN HONG KONG. IT WAS REPORTED THAT THERE WAS A "WEIRD NOISE" DURING PATIENT TREATMENT. THE INVOLVED CARDIOHELP DEVICE AS WELL AS THE HLS-SET INVOLVED WERE REPLACED. THE HLS-SET WAS NOT KEPT BY THE CUSTOMER FOR INVESTIGATION. DURING INSPECTION OF THE CARDIOHELP DEVICE BY THE TECHNICIAN NO MALFUNCTION WAS FOUND. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE INVOLVED CARDIOHELP DEVICE WILL BE INVESTIGATED UNDER COMPLAINT ID# (B)(4). AS THE HLS-SET WAS REPLACED DURING TREATMENT, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29005 | TUBING SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | HLS SET | 3000506411 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |