MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO® CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number D1000

Device Problem Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2022

Event Type  malfunction  

Event Description

The device involved is tego® connector.The reporter stated that an air bubble was detected on a fresenius 6008® device, resulting in an alarm and blood pump stopping.Upon check, a large air bubble is visible in the bloodline, right after the arterial tego connector in close proximity to the patient catheter.The machine was put to circulate until the air disappeared and then the patient was again connected.The alarms reoccurred again after approximately 3 hours of dialyses.There were 2 tegos used, 1 tego used on the arterial line and used on the venous line.The tego connector that will be returned was initially being used on the patient on (b)(6) 2022 and the event occurred on (b)(6) 2022 during normal dialyses treatment.The event occurred approximately after 1.5 dx treatments.The tego connector was removed immediately after the event was detected.There was no blood loss and no additional treatment was required.There was no patient harm reported.

Manufacturer Narrative

The device is expected to be returned to the manufacturer; however, it has not yet been received.

Manufacturer Narrative

E1 - initial reporter facility name, initial reporter address 1, initial reporter city, initial reporter postal code.

Manufacturer Narrative

Received two (2) used.List #d1000, tego¿ connector.Visual: no damages or anomalies were noted.Functional: tego pressure and vacuum leak testing: low pressure inactivated pressure leak test, (ps65-00001 section 4, p-1g-068): pass.High pressure activated pressure leak test, (ps65-00001 section 5, p-1g-068): pass.Vacuum leak testing - inactivated, (ps65-00001 section 6, p-1g-068): pass.Vacuum leak testing - activated, (ps65-00001 section 6, p-1g-068): pass.Sample two (2): tego pressure and vacuum leak testing: low pressure inactivated pressure leak test, (ps65-00001 section 4, p-1g-068): pass.High pressure activated pressure leak test, (ps65-00001 section 5, p-1g-068): pass.Vacuum leak testing - inactivated, (ps65-00001 section 6, p-1g-068): pass.Vacuum leak testing - activated, (ps65-00001 section 6, p-1g-068): pass.The complaint of air in line could not be confirmed on the returned two (2) used.List #d1000, tego¿ connector, appx 0.05 ml; lot #5626565.Each tego was leak tested per product specification.No leaks were observed.The returned two (2) used.List #d1000, tego¿ connector met product specifications.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 product return to mfg date 5/24/2022.

• Brand Name: TEGO® CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 14468500
• MDR Text Key: 292353448
• Report Number: 9617594-2022-00138
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)261001(10)5626565
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D1000
• Device Catalogue Number: D1000
• Device Lot Number: 5626565
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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: BD PLASTIPACK 10ML LL SYRINGE; FRESENIUS 6008; FRESENIUS 6008 BLOODLINE (REF. F00007727); MEDCOMP TITAN HD LONG-TERM HEMODIALYSES CATHETER