Transpac™ 46103-68Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887709050723), received between Jul 13, 2017 and Apr 9, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 9, 2021Overheating of Device; Overheating of Device

  A USER FACILITY MANDATORY MEDWATCH (# (B)(4)) WAS RECEIVED THAT STATED, "PATIENT TAKEN DOWN TO MRI FOR ABDOMINAL WITH CONTRAST. SCAN WAS PAUSED FOR PATIENT MOVEMENT. UPON ENTERING THE ROOM AGAIN, RN AND MRI STAFF IMMEDIATELY NOTICED BURNING SMELL WHICH WAS NOT NOTICED PREVIOUSLY. UPON FURTHER INVESTIGATION, RN NOTICED ARTERIAL BLEEDING FROM PATIENTS LEFT RADIAL A-LINE TRANSDUCER SITE NEAR THE LEFT UPPER LATERAL ARM. RN LOCKED A-LINE TO STOP THE BLEEDING AND FURTHER NOTICED LARGE BURN SITE UNDER THE A-LINE TRANSDUCER." ADDITIONAL INFORMATION INCLUDED ON THE MEDWATCH: OUTCOME ATTRIBUTED TO ADVERSE EVENT, OTHER SERIOUS (IMPORTANT MEDICAL EVENTS) AND REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT / DAMAGE (DEVICES). PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT: HEPATIC/RENAL DYSFUNCTION. IT WAS ALSO ADDED UNDER FOR USE BY USER FACILITY/IMPORTER THAT EVENT HAPPENED AT THE HOSPITAL. ADDITIONAL INFORMATION RECEIVED: THE EXACT TIME OF THE EVENT WAS ON 10:56:00AM STATING THE PATIENT WAS INTENSIVE CARE UNIT (ICU) STATUS, AND DURING A STAT MAGNETIC RESONANCE IMAGING (MRI) THE CABLED BURNED WITH THE PATIENT RECEIVING A BURN. THE PATIENT WAS HEMODYNAMICALLY STABLE A

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 11640947 ↗
• MalfunctionJul 18, 2017Detachment Of Device Component; Detachment Of Device Component

  COMPLAINT RECEIVED REPORTING COMPONENT SEPARATION WITH USE OF ONE 46103-68 TRANSPAC IV W/SAFESET RESV MTG KIT. THE INITIAL INFORMATION RECEIVED REPORTS AT AN UNSPECIFIED TIME AFTER PLACEMENT THE 46103-68 MTG. KITS "..PRESSURE TUBING DISCONNECTED FROM THE MALE LUER. THE MALE LUER REMAINED CONNECTED TO THE 1-WAY STOPCOCK..". THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION ALTHOUGH REQUESTED BY THE MANUFACTURER WAS NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6722815 ↗
• MalfunctionJul 18, 2017Detachment Of Device Component; Detachment Of Device Component

  COMPLAINT RECEIVED REPORTING COMPONENT SEPARATION WITH USE OF ONE 46103-68 TRANSPAC IV W/SAFESET RESV MTG KIT. THE INITIAL INFORMATION RECEIVED REPORTS AT AN UNSPECIFIED TIME AFTER PLACEMENT THE 46103-68 MTG. KITS "..PRESSURE TUBING DISCONNECTED FROM THE FEMALE LUER (LOCATION MARKED WITH A FENTANYL STICKER). THE FEMALE LUER REMAINED CONNECTED TO THE 3-WAY ZEROING STOPCOCK". THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION ALTHOUGH REQUESTED BY THE MANUFACTURER WAS NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6722740 ↗
• MalfunctionJul 13, 2017Leak/Splash; Leak/Splash

  DURING THE BLOOD SAMPLING PROCESS BLOOD SPURTED FROM THE LUER ACTIVATED SAMPLING PORT WHILE ATTEMPTING TO RETURN BLOOD TO THE PATIENT. THE NURSE COULD NOT FLUSH THE LINE DESPITE ALL STOPCOCK HANDLES IN THE CORRECT POSITION. THE SAFESET PLUNGER HANDLE WAS STUCK IN THE "OPEN" POSITION AND COULD NOT BE PUSHED FORWARDED TO LOCK. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6712120 ↗

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