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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 W/03 ML SQUEEZE FLUSH DEVICE, MICROCLAVE®, 03 ML SAF; INVASIVE BLOOD PRESSURE MONITORING DISPOSABLES

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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, MICROCLAVE®, 03 ML SAF; INVASIVE BLOOD PRESSURE MONITORING DISPOSABLES Back to Search Results
Catalog Number 011-46115-21
Device Problems Disconnection (1171); Separation Failure (2547)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2022
Event Type  malfunction  
Event Description
The event involved a transpac® iv monitoring kit w/03 ml squeeze flush device, microclave®, 03 ml safeset¿ reservoir and blood sampling port.It was reported that the safeset became loose and disconnected between the reservoir and the line going to the patient (the diluent set was disconnected from the two way valve).It appeared that the adhesive hadn¿t stuck and adhesive was observed at the point of disconnection.The safeset was replaced with a new one that was not loose and did not appear that it would come apart in the same area.The number of hours the device was used was 0.1.No medication was being used with the product.There was no leakage.Although there was a delay in therapy, there was patient involvement and no human harm.This captures the first of two events reported.
 
Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.The customer identified 3 possible lot numbers (plots): 5201049 (expiry date 02/01/2024, mfr date 03/01/2021).5254594 (expiry date 04/01/2024, mfr date 05/01/2021).5487785 (expiry date 07/01/2024, mfr date 12/01/2020).
 
Manufacturer Narrative
The complaint of separation can be confirmed on the returned used list #011-46115-21, transpac® iv monitoring kit w/03 ml squeeze flush device, microclave®, 03 ml safeset¿ reservoir and blood sampling port; lot #unknown.As received, the stopcock was separated from the base of the barrel reservoir.The area of the separation was examined.There was adhesive observed on the base of the barrel reservoir.However, the observed adhesive was tacky.The probable cause of the separation observed is due to uv adhesive not being fully cured during the manual assembly process during manufacturing.D9 - date returned to mfg: 7/7/2022.Additional entries can be found in a5, a6 and h6 (component code).
 
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Brand Name
TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, MICROCLAVE®, 03 ML SAF
Type of Device
INVASIVE BLOOD PRESSURE MONITORING DISPOSABLES
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 Key14713748
MDR Text Key294172604
Report Number9617594-2022-00175
Device Sequence Number1
Product Code DRS
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K052828
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 05/19/2022
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 Number011-46115-21
Device Lot NumberPLOTS
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/19/2022
Initial Date FDA Received06/16/2022
Supplement Dates Manufacturer Received07/27/2022
Supplement Dates FDA Received08/23/2022
Was Device Evaluated by Manufacturer? Yes
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
HEPARIN SODIUM 0.45% SODIUM CHLORIDE, MFR UNK
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