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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. TP ST MONITORING KIT BELGIUM; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TP ST MONITORING KIT BELGIUM; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR Back to Search Results
Catalog Number 011-0P544-01
Device Problems Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2022
Event Type  malfunction  
Event Description
The event occurred on (b)(6) 2022 at cardiac surgery block and involved a tp st monitoring kit belgium.The customer stated that prior to use it was noted on the device that the screw threads were not sufficiently glued, generating leaks and bubbles in the cardioplegia circuit.The event was observed at least twice, one week apart, where there was a string of air bubbles on a cardioplegia line.The air bubbles did not come in contact with a patient.The drug that was used during the event was a physiological serum and the leak did not come in contact with a patient or the operator.The device was not replaced, the screw was tightened, and therapy was completed.There was a 5-10 minute delay in therapy, however no report of patient involvement, no patient harm, and no need for medical intervention.This captures 2 of 2 occurrences.
 
Manufacturer Narrative
The involved device is not available for evaluation, however a sister sample is available.The device has not yet been received.
 
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 no nonconformities were identified that may have contributed to the reported complaint.
 
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Brand Name
TP ST MONITORING KIT BELGIUM
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 Key14863423
MDR Text Key303232774
Report Number9617594-2022-00197
Device Sequence Number1
Product Code DRS
UDI-Device Identifier00840619030308
UDI-Public(01)00840619030308(17)240901(10)5606984
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,Followup
Report Date 06/03/2022
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 Expiration Date09/01/2024
Device Catalogue Number011-0P544-01
Device Lot Number5606984
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/03/2022
Initial Date FDA Received06/29/2022
Supplement Dates Manufacturer Received08/03/2022
Supplement Dates FDA Received08/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2021
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
UNSPECIFIED PHYSIOLOGICAL SERUM, UNK MFR
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