MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT TRIFURCATED MONITORING KIT, 60", 3ML FLUSH DEVICES, MACRODRIP (POLE; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number	42800-07
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is not yet complete.Uf/importer report # (b)(4).
Event or Problem Description
The event involved a transpac¿ it trifurcated monitoring kit, 60", 3ml flush devices, macrodrip (pole mount) where it was reported that the product kept on disconnecting while in use.Test done with the product and the parts disconnected.The patient was fresh post operation from the operating room (or).A few minutes later, all three of the flush lines connected to the transducers broke apart one by one.There was a blood back flow from the arterial line.They ended up changing the whole system.It was stated that the set up was fine with no problem.Transducer tubes broke apart and separated from transducer and started leaking while the patient was in cardiac surgery intensive care unit (csicu).The setup was in the morning and patient left or by noon to csic.In csicu, the tubes started to become lose and leaking fluid and blood backflow, they changed the set-up immediately upon patient arrival to the floor.There was a small amount of blood leak.The status during set-up was fine but after transporting patient csic the transducer started to leak, and tubes separate.Additionally, it was reported on the medwatch report that "all 3 of the pigtails of the icu medical transpac iv trifurcated monitoring kit broke apart when connected to patient's pulmonary artery (pa) catheter, central venous pressure (cvp), and arterial lines¿.It was indicated on the report that the lot disconnected when in use for testing.There was patient involvement and delay in therapy.However, there was no medical intervention, no change in patient¿s condition, and no harm.
Additional Manufacturer Narrative
Received: (b)(4) used.List #42800-07, transpac¿ it trifurcated monitoring kit, 60", 3ml flush devices, macrodrip (pole mount); lot #5819705.The reported complaint of disconnection was confirmed on the returned sets.(b)(4) used: during visual inspection, the three pvc tubing ends were received separated from the luer pocket.All the three tubing pockets observed to be tacky.The probable cause of the pvc tubing separated from the luer pocket on both the samples had occurred due to uv adhesive not being fully cured during assembly at manufacturing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Additional Manufacturer Narrative
Received: one used partial.List #42800-07, transpac¿ it trifurcated monitoring kit, 60", 3ml flush devices, macrodrip (pole mount); lot #5819705.The reported complaint of disconnection was confirmed on the returned sets.One used partial: during visual inspection, the three pvc tubing ends were received separated from the luer pocket.Only one transducer was returned for evaluation.All the three tubing pockets observed to be tacky.The probable cause of the pvc tubing separated from the luer pocket on both the samples had occurred due to uv adhesive not being fully cured during assembly at manufacturing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC¿ IT TRIFURCATED MONITORING KIT, 60", 3ML FLUSH DEVICES, MACRODRIP (POLE
• Common Device Name: 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: 15362252
• Report Number: 9617594-2022-00255
• Device Sequence Number: 15000706
• Product Code: DRS
• UDI-Device Identifier: 00887709097629
• UDI-Public: (01)00887709097629(17)250201(10)5819705
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2025
• Device Model Number: 42800-07
• Device Catalogue Number: 42800-07
• Device Lot Number: 5819705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 09/28/2022; 09/28/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 10/18/2022; 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female