ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. EXT SET, SMALLBORE TRIFUSE WITH 3 CLAVE¿; STOPCOCK, I.V. SET
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Catalog Number 011-C3323 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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The complaint/event involved a ext set, smallbore trifuse with 3 clave¿.The clave was reported to have detached from the tubing during infusion of total parental nutrition (tpn).The reporter stated that the complaint/issue was causing patients to be at risk for blood loss, infection and/or loss of essential treatment.The remaining batch inventory stock was been removed and replaced with a new batch.No current incidents have been recorded since the switch.The issue was not detected prior to direct patient use.There was no serious injury/death, no blood loss, no unprotected chemo exposure, no adverse operator consequences and no medical/surgical intervention required.The customer reported an unspecified delay in critical therapy.The current status of the patient is 'returned to baseline condition'.There was not any holes, cuts or defects noted on the medical device and the tubing was not reprocessed/re-sterilized.The device was changed out/replaced with no further problems encountered.This record reflects the first of three reports.
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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.Section e initial reporter full phone number: (b)(6).
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Manufacturer Narrative
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The b3 - date of event was updated from 12dec2023 to (b)(6) 2023.
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Manufacturer Narrative
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The following was returned (or provided) by the customer for complaint investigation -sample #1 (of 2) used list # 011-c3323, ext set, smallbore trifuse with 3 clave¿; lot #unknown -a picture showing a microclave detached from the tubing the housing on the sample #1 used return device was noted to be a different color than sample #2 indicating they may be from different lots.Sample 1 was received with one microclave seperated from the tubing.The bonding areas were observed and it was noted that part of the tubing was still inside the microclave assembly.The tube was noted to have rough edges.Ultraviolet (uv) light inspection showed sufficient solvent on sample 1.The complaint of the clave detaching from the tubing can be confirmed.The probable cause of the detachment on sample 1 is due to unintentional pulling forces.The lot history of the provided lot number was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 16feb2024.
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