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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV W/03 ML SQUEEZE FLUSH DEVICE, 60" MACRO ADMIN SET AND PRESSURE TUBI; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV W/03 ML SQUEEZE FLUSH DEVICE, 60" MACRO ADMIN SET AND PRESSURE TUBI; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR Back to Search Results
Catalog Number 011-46106-74
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2024
Event Type  malfunction  
Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.
 
Event Description
The event occurred involved a transpac® iv w/03 ml squeeze flush device, 60" macro admin set and pressure tubing (152cm) where the customer reported unspecified leakage(s) have occurred with use of 011-46106-74.It was reported the sheets and patient were wet from the ssi leaking into the bed.The medication involved was ssi with heparin.No information regarding how long after the infusion the leak occurred.The tubing was changed, and treatment was resumed.The customer stated, "even if it is not a treatment, it provides the counter pressure of the arterial kt." there was patient involvement, however, no report of patient harm.
 
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Brand Name
TRANSPAC® IV W/03 ML SQUEEZE FLUSH DEVICE, 60" MACRO ADMIN SET AND PRESSURE TUBI
Type of Device
TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
avenida cuarzo no. 250
ensenada, b.cfa. 22790
MX  22790
Manufacturer Contact
reed covert
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key18921339
MDR Text Key337867970
Report Number9617594-2024-00277
Device Sequence Number1
Product Code DRS
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K061573
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 03/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number011-46106-74
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/20/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ARTERIAL LINE CATHETER, UNK MFR; HEPARIN, UNK MFR; SSI, UNK MFR
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