Perfadex with THAM 19018Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07350069520067), received between Jun 29, 2018 and Jun 29, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• MalfunctionJun 29, 2018Fluid/Blood Leak; Hole In Material; Nonstandard Device

  THIS INFORMATION WAS PROVIDED BY THE CUSTOMER TO THE FDA IN A VOLUNTARY MEDWATCH REPORT (MW5077650) DATED (B)(6) 2018. "PHYSICIANS AND PROCUREMENT STAFF WERE INVOLVED IN A LUNG RECOVERY. THE PERFADEX PRESERVATION SOLUTION WAS TRANSPORTED TO THE FACILITY IN A COOLER. ONE BAG OF SOLUTION WAS INFUSED DURING THE RECOVERY AND A SECOND BAG WAS PREPPED FOR INFUSION AFTER THE LUNGS WERE RECOVERED. AFTER APPROXIMATELY HALF OF THE FLUID WAS INFUSED FROM THE SECOND BAG, A SMALL HOLE WAS DISCOVERED IN THE TOP PORTION OF THE BAG. THE RECOVERY SURGEONS WERE INFORMED ABOUT THE INCIDENT AS WELL AS THE TRANSPLANTING SURGEON AND THE DECISION WAS MADE TO CONTINUE WITH THE PROCEDURE. THE HOLE WAS VERY SMALL AND ONLY A SMALL STREAM OF FLUID LEAKED FROM THE BAG WHEN PRESSURE WAS APPLIED. A REPORT WAS FILED WITH THE (B)(4). MFR (XVIVO PERFUSION) HAS BEEN CONTACTED (AND RESPONDED QUICKLY) AS WELL. ALTHOUGH THE MANUFACTURER DENIED ANY CURRENT RECALL NOTICES (I HAD ALSO VERIFIED RECALLS ON THE FDA SITE), THEY DID STATE THAT AS OF 2018, THEY HAVE A NEW BAG DESIGN THAT WILL HOPEFULLY ELIMINATE FUTURE INCIDENTS. WE WILL CONTINUE TO MONITOR THE PATIENT CLOSELY. AT PRESENT, THE PATIENT IS RECOVERING WITHOUT INCI

  Patient problems: No Information

  MAUDE report 7650347 ↗