TUBING SET
Report
- Report Number
- 8010762-2026-0000088
- Event Type
- Malfunction
- Date Received
- March 2, 2026
- Date of Event
- February 23, 2026
- Report Date
- May 27, 2026
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTZ
- UDI-DI
- 04058863080383
- PMA / PMN Number
- K112360
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
ON (B)(6) 2026 THE CUSTOMER CONFIRMED THAT THE HLS SET WAS USED FURTHER AS THERE WAS NO ISSUE WITH PRESSURE/FLOW OR SUPPORTING THE PATIENT. THE PATIENT WAS SUCCESSFULLY DECANNULATED ON A LATER POINT. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
NEW INFORMATION WAS RECEIVED ON 2026-05-11 FROM THE CUSTOMER ABOUT THE PATIENT DATA: THE PATIENTS INITIALS ARE MM, HEIGHT 162.6CM. THERE WAS NO OTHER MEDICAL DEVICE USED WITH THE CIRCUIT AND THERE WERE NO KNOWN ENVIRONMENTAL CONDITIONS THAT COULD HAVE INFLUENCED THE DEVICE. HISTORY OF PATIENT IS: OSA, CAD, HTN, OBESITY, SVT, A FEW LHC WITH PCI, HEART FAILURE. PATIENT ADMITTED FOR CP AND SOB. RECURRENT POLYMORPHIC VT AND CARDIAC ARREST. AS THE CUSTOMER CONFIRMED THAT THE HLS SET WAS NOT REPLACED DURING TREATMENT AND THE THERAPY WAS CONTINUED AND THE PATIENT WAS DECANNULATED SUCCESSFULLY ON A LATER POINT, THIS COMPLAINT IS DEEMED AS NOT REPORTABLE. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
THE EVENT OCCURRED IN USA DURING TREATMENT. IT WAS REPORTED THAT A NOISE OCCURRED WHICH SOUNDED LIKE AN HLS SET DECOUPLING NOISE ACCORDING TO THE CUSTOMER. THE CUSTOMER TRIED TO RECOUPLE THE HLS SET BUT THE NOISE CONTINUED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT THERAPY. THE PATIENT HAD A FLOR OF 4.67 LPM. THE CUSTOMER TURNED THE FLOW UP TO 5LPM AT 4100RPM AND THERE WAS NO NOISE. THE PATIENT WAS ON THE HLS SET FOR LESS THAN 24 HOURS. NO HARM TO ANY PERSON HAS BEEN REPORTED. NEW INFORMATION RECEIVED ON (B)(6) 2026 THAT THE HLS SET WAS NOT REPLACED. THERE WAS NO VISIBLE DAMAGE ON THE HLS SET. THE PATIENT WAS CONNECTED ON THE HLS SET ON (B)(6) 2026 AND THE EVENT OCCURRED ON (B)(6) 2026. FOLLOWING PATIENT DATA WAS SHARED: 49 YEARS OLD MALE WITH 132.3KG. THE SET WAS PRIMED DIRECTLY BEFORE TREATMENT. THE PRIMING WAS FINISHED WHILE THE PATIENT WAS CANNULATED. AS THERE WAS A NOISE DURING TREATMENT, AND THIS CAN RESULT IN AN HLS SET REPLACEMENT, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).
COMPLAINT ID (B)(4).
COMPLAINT ID (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340509 | TUBING SET | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | HLS SET | 3000507661 | 04058863080383 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |