MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TP ST MONITORING KIT BELGIUM; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

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  

Manufacturer Narrative

The involved device is not available for evaluation, however a sister sample is available.The device has not yet been received.

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 1 of 2 occurrences.

Manufacturer Narrative

One new list #011-0p544-01, monitoring kit was received for evaluation.No visual anomalies were observed on the returned set.The reported complaint of leakage and air bubbles were not confirmed on the returned set.No visual anomalies were observed on the returned set.When the returned set was primed and pressure leak tested, no leaks were observed.The product had performed per the specifications.Without the return of the reported sample, this complaint could not be confirmed.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional information d9: date returned to manufacturer 6/30/2022.

• 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 Key: 14863401
• MDR Text Key: 300922090
• Report Number: 9617594-2022-00196
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619030308
• UDI-Public: (01)00840619030308(17)240901(10)5606984
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• 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 Date: 09/01/2024
• Device Catalogue Number: 011-0P544-01
• Device Lot Number: 5606984
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 08/03/2022
• Supplement Dates FDA Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED PHYSIOLOGICAL SERUM, UNK MFR