ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO¿ CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number D1000 |
Device Problems
Connection Problem (2900); Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device is available to be returned for evaluation; however, it has not yet been received.Additional information: lot number 5916730: mfr date: 4/2022, expiry date: 4/2027.5891775: mfr date: 4/2022, expiry date: 3/2027.5891769: mfr date: 4/2022, expiry date: 3/2027.
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Event Description
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It was reported that a tego connector was not attaching to the line properly.The examination, results, and comments stated: examination in the laboratory identified a possible compatibility issue between the tego hemodialysis connector and novaline haemodialysis tubing sets which may have contributed to the clinical incident.Two and a half hours into a 4-hour hemodialysis session, the arterial line had disconnected from the patient's permcath resulting in air being pulled through the machine, however, no air reached the patient and the patient was not at risk.It was later discovered that the tego was not attaching to lines properly.The location of the faulty lock was the silicone-sheathed luer connection between the tego and the tubing set.There was no harm to the patient reported.
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Event Description
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It was reported that "the patient lost part of their hemodialysis (hd) circuit.This means a small amount of blood was lost in the hd circuit (<15mls)." the customer stated that the "patient's hemodialysis machine was made up again and dialysis restarted".There was no patient harm.
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Manufacturer Narrative
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The received new d1000 tego connectors were measured and functionally tested for leakage.Both assemblies met design and performance expectations.The complaint of leakage resulting from connection to the d1000 tego assemblies was unable to be replicated or confirmed.Lot history records for the possible lot numbers were reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional information: product receive date: 3/6/2023.
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