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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 MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH, MACRODR; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH, MACRODR; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR Back to Search Results
Catalog Number 01C-42584-05
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2023
Event Type  malfunction  
Event Description
It was reported that the device leaked at the interface.There was no patient harm reported.No additional information is available at this time.
 
Manufacturer Narrative
The device was not returned for evaluation.Without the return of the sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The lot history was reviewed and there were no nonconformities that would have contributed to the reported complaint.E1: additional contact: (b)(6).
 
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Brand Name
TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH, MACRODR
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
michael visocnik
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key17276778
MDR Text Key318965331
Report Number9617594-2023-00324
Device Sequence Number1
Product Code DRS
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K061573
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number01C-42584-05
Device Lot Number8602207
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/09/2023
Initial Date FDA Received07/07/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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