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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, SAFESET¿ RESERVOIR, 84; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

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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, SAFESET¿ RESERVOIR, 84; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR Back to Search Results
Catalog Number 011-46110-29
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/31/2023
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for evaluation, however, it is yet to be received.
 
Event Description
The event involved a transpac® iv monitoring kit w/03 ml squeeze flush device, safeset¿ reservoir, 84" red stripe arterial pressure tubing and 2 needleless valves which was reported to have leaked isotonic solution for arterial catheter during patient use.The customer reported that a line where one of the connections, normally crimped, was leaking.The customer reported a delay in therapy, about 20 min (two circuits to re-prime and reinstall).The patient¿s condition was said to be unmodified.The device was removed and reinstalled under strict aseptic conditions twice.There was no physical defect noted before use.The leak was cleaned-up as per facility protocol.There was patient involvement, however, no harm was reported as a consequence of this event.
 
Manufacturer Narrative
One used device was returned for evaluation on 8/29/23.No visual anomalies were observed on the returned set.The returned set was primed and pressure leak tested; no leaks were observed.The product performed per the specifications.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
 
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Brand Name
TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAFESET¿ RESERVOIR, 84
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 Key17190665
MDR Text Key317758677
Report Number9617594-2023-00263
Device Sequence Number1
Product Code DRS
UDI-Device Identifier00840619068684
UDI-Public(01)00840619068684(17)250601(10)6032802
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 06/05/2023
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 Number011-46110-29
Device Lot Number6032802
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/05/2023
Initial Date FDA Received06/23/2023
Supplement Dates Manufacturer Received09/22/2023
Supplement Dates FDA Received10/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ISOTONIC SOLUTION, MFR UNK
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