Hyperthermia Pump St In/Out Pt Line 902-00039PRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00896128002169), received between Sep 21, 2022 and Oct 21, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K152208); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IN THE PROCEDURE FOR RECURRENT PERITONEAL MALIGNANT MESOTHELIOMA; VENTRAL HERNIA, SHORTLY AFTER BEGINNING CIRCULATION OF CHEMOTHERAPY SOLUTION VIA BELMONT HYPERTHERMIA PUMP, NURSE NOTICED A LEAK COMING FROM THE BOTTOM OF THE FLOOR OF THE DEVICE. THE NURSE PROMPTLY NOTIFIED THE SURGEON AND STOPPED THE INFUSION. UPON OPENING THE PUMP DOOR WHICH HOUSES THE DISPOSABLE HEAT EXCHANGER, A LEAK WAS OBSERVED AT THE CONNECTOR PORTION OF THE HEAT EXCHANGER RING. REALIZING THERE WAS NO WAY TO FIX THE DISPOSABLE, AFTER WHICH THE LEAK-CONTAMINATED AREAS WERE CLEANED PER THE PROTOCOL AND REPLACED THE DAMAGED HEAT EXCHANGER WITH A NEW ONE OF A NEW LOT NUMBER IN A STERILE FASHION. RE INFUSION WAS RESTARTED AND THERE WERE NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15655057 ↗
• MalfunctionSep 21, 2022Fluid/Blood Leak

  SHORTLY AFTER BEGINNING CIRCULATION OF CHEMOTHERAPY SOLUTION VIA BELMONT HYPERTHERMIA PUMP, I NOTICED A LEAK COMING FROM THE BOTTOM OF THE FLOOR OF THE DEVICE. I PROMPTLY NOTIFIED THE SURGEON AND STOPPED THE INFUSION. UPON OPENING THE PUMP DOOR WHICH HOUSES THE DISPOSABLE HEAT EXCHANGER, I OBSERVED A LEAK AT THE CONNECTOR PORTION ABOUT THE HEAT EXCHANGER RING. REALIZING THERE WAS NO WAY TO FIX THE DISPOSABLE, I ALERTED THE SURGEON THAT THE HEAT EXCHANGER PORTION WOULD NEED TO BE REPLACED, TO WHICH SHE AGREED. I CLEANED THE LEAK-CONTAMINATED AREAS PER THE PROTOCOL AND REPLACED THE DAMAGED HEAT EXCHANGER WITH A NEW ONE OF A NEW LOT NUMBER IN A STERILE FASHION. WE THEN RESTARTED REINFUSION AND EXPERIENCED NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461858 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152208. One submission often covers many models, so check the product and lot details in each record.

• Z-1674-2025 · Mar 31, 2025 · Open, Classified
  Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) co
• Z-1675-2025 · Mar 31, 2025 · Open, Classified
  Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line
• Z-1676-2025 · Mar 31, 2025 · Open, Classified
  Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient L