Transpac™ 46104-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709050846), received between Sep 24, 2018 and Apr 17, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Prime” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K052828); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025No Flow; No Flow

  THE EVENT INVOLVED A TP4 KIT W/10CC SAFESET RESERVOIR, NEEDLELESS VALVE FILTER MILLEX AND ADMIN SET WHERE IT WAS REPORTED THE REGISTERED NURSE (RN) DREW LABS FROM THE A-LINE WITHOUT ISSUE; HOWEVER, WHEN HE ATTEMPTED TO FLUSH THE LINE, HE WAS UNABLE TO PULL ANY FLUSH FROM THE BAG. THE A-LINE STILL HAD A GOOD WAVEFORM AND BLOOD RETURN. THE LINE WAS CHANGED OUT AND THE OLD LINE WAS PLACED. THERE IS POTENTIAL PATIENT HARM WITH EXTRA LINE CHANGE AT RISK FOR CLABSI. THERE WERE NO OTHER DEVICES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859446 ↗
• MalfunctionNov 8, 2023No Flow; No Flow

  THE EVENT INVOLVED A THE EVENT INVOLVED A TP4 KIT W/10CC SAFESET RESERVOIR, NEEDLELESS VALVE, FILTER MILLEX AND ADMIN SET. IT WAS REPORTED THAT WHEN HANGING ALINE TUBING, IT WAS CONNECTED TO PATIENT AND WAS NOT ABLE TO FLUSH LINE, AND BLOOD STARTED TO BACKFLOW INTO THE LINE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED. THE SET-UP WAS REPLACED AND THERAPY WAS RESUMED. THERE WERE NO INTERVENTIONS NEEDED RELATED TO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18098020 ↗
• MalfunctionSep 24, 2018Failure to Prime; Failure to Prime

  THE EVENT OCCURRED ON AN UNKNOWN DATE IN (B)(6) AND (B)(6) 2018. THE EVENT INVOLVED A CUSTOMER REPORT STATING THAT TP4 KIT WITH 10CC SAFESET RESERVOIR, NEEDLELESS VALVE, FILTER MILLEX AND ADMIN SET WOULD NOT PRIME, AS THOUGH THERE WAS A BLOCKAGE IN THE FILTER THAT PREVENTS FLUID FROM PASSING THROUGH. THE DEVICE WAS REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7902838 ↗
• MalfunctionSep 24, 2018Failure to Prime; Failure to Prime

  THE EVENT OCCURRED ON AN UNKNOWN DATE IN (B)(6) AND (B)(6) 2018. THE EVENT INVOLVED A CUSTOMER REPORT STATING THAT TP4 KIT WITH 10CC SAFESET RESERVOIR, NEEDLELESS VALVE, FILTER MILLEX AND ADMIN SET WOULD NOT PRIME AS THOUGH THERE WAS A BLOCKAGE IN THE FILTER THAT PREVENTS FLUID FROM PASSING THROUGH. THE DEVICE WAS REPLACED WITH NO FURTHER PROBLEMS ENOUNTERED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7902822 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052828. One submission often covers many models, so check the product and lot details in each record.

• Z-1071-2019 · Nov 27, 2018 · Terminated
  ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06