Catalog Number 109990 |
Device Problems
Disconnection (1171); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/27/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that at an unknown time during continuous renal replacement therapy using a prismaflex control unit and a prismaflex m150 set, one of the m150 blood lines became disconnected from the bard power trialysis dialysis catheter.This reportedly resulted in "minimal" blood loss.An air detector alarm was generated by the control unit.The nurse immediately clamped the lines, stopped treatment and aspirated air from the lines.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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The device was received for evaluation.Visual inspection was performed and did not identify any abnormalities that could have contributed to the reported condition.Pressure testing was performed, and no leaks were noted.The reported condition was not verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Lox file was analyzed and no specific issues were identified on the set and on the control unit.The lox file observed that pressure records indicated that a temporary set occlusion occurred during treatment (due to clamp, clot or line being crushed by patient moving) and to confirm that a catheter disconnection occurred, leading to the end of the treatment.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Correction: b4/f8: date of this report in the initial mdr is being corrected from blank to 06/21/2021.
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Search Alerts/Recalls
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