ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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Catalog Number 050-87216 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problems
Abdominal Pain (1685); Peritonitis (2252)
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Event Date 03/12/2024 |
Event Type
Injury
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Manufacturer Narrative
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Clinical review: a temporal relationship exists between the pd therapy with the liberty cycler set and the patient¿s peritonitis event.The patient reportedly experienced a hole in the fresenius cassette prior to developing peritonitis.Based on the reported information, it cannot be determined what may have caused the hole in the liberty cycler set.The actual product used has been discarded and will not be returned to the manufacturer for product analysis.However, companion samples (from the same lot) will be sent back to the manufacturer for further product analysis.Due to the known risk of peritonitis when a breach in the sterile pd circuit occurs, the liberty cycler set cannot be excluded in the peritonitis event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
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Event Description
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It was reported that this patient on peritoneal dialysis (pd) had a cassette with a hole and the patient developed peritonitis.The patient was seen in the outpatient pd clinic for symptoms of abdominal pain and cloudy pd effluent.It was stated that the patient had a pd culture obtained which grew the bacteria streptococcus sanguinis.The patient was treated with intra-peritoneal (ip) antibiotics with vancomycin and ceftazidime (per clinic protocol) on an outpatient basis.The patient is recovering from the event.Per the nurse, the patient continues pd therapy with the same cycler and a new batch of fresenius cassettes (lot number unknown) without any further issues.The nurse attributed the peritonitis to the fluid leak from the hole in the fresenius cassette.
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Manufacturer Narrative
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Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
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Event Description
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It was reported that this patient on peritoneal dialysis (pd) had a cassette with a hole and the patient developed peritonitis.The patient was seen in the outpatient pd clinic for symptoms of abdominal pain and cloudy pd effluent.It was stated that the patient had a pd culture obtained which grew the bacteria streptococcus sanguinis.The patient was treated with intra-peritoneal (ip) antibiotics with vancomycin and ceftazidime (per clinic protocol) on an outpatient basis.The patient is recovering from the event.Per the nurse, the patient continues pd therapy with the same cycler and a new batch of fresenius cassettes (lot number unknown) without any further issues.The nurse attributed the peritonitis to the fluid leak from the hole in the fresenius cassette.
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