V. Mueller SU2800Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403064562), received between Aug 17, 2023 and Aug 17, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2023Leak/Splash; Leak/Splash

  PATIENT WAS BORN VIA CESARIAN SECTION (C/S). UPON ARRIVAL TO THE INFANT WARMER, IT WAS NOTED THE KOCHER CLAMP HAD COME UNDONE RESULTING IN SIGNIFICANT BLOOD LOSS. APGAR SCORE WAS 1 AT 1 MIN AND 5 AT 5 MIN. BABY WAS ADMITTED TO SPECIAL CARE NURSERY FOR RESPIRATORY DISTRESS, STATUS POST RESUSCITATION, AND BLOOD LOSS FROM UMBILICAL CORD. 1.5 HOURS LATER, NURSING NOTED DESATURATIONS AND LOW BLOOD PRESSURE (BP) REQUIRING TRANSITION BACK TO CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) AND A NORMAL SALINE (NS) BOLUS. PEDIATRICIAN CONTACTED NEONATOLOGY WITH A DECISION TO TRANSFER FOR HIGHER LEVEL OF CARE. IN THE NEONATAL INTENSIVE CARE UNIT (NICU) BABY RECEIVED BLOOD PRODUCTS. UNKNOWN AT THIS TIME IF THIS WAS FAILURE OF THE USER TO PROPERLY CLAMP OR IF THE CLAMP ITSELF DID NOT FUNCTION AS INTENDED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? CLAMP THE NEWBORN UMBILICAL CORD. NO FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17567650 ↗