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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. UNKNOWN- FMC PRODUCT DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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ERIKA DE REYNOSA, S.A. DE C.V. UNKNOWN- FMC PRODUCT DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number UNKNOWN-FMCPRODUCT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Peritonitis (2252)
Event Date 05/26/2021
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.   clinical investigation: there is a temporal relationship between pd therapy with utilization of the pd catheter extension set and the patient event of infection with potential peritonitis and possible pd catheter removal. However, there is no documentation in the complaint file to show a causal relationship between the adverse event and the extension set. The patient admitted to falling asleep with scissors in his hand resulting in the extension set being cut. It was later reported that the patient had an infection with possible peritonitis due to this event. Based on the available information and no allegation of a defect, the pd catheter extension set can be excluded as the cause of the patient¿s infection with possible peritonitis and potential pd catheter removal.
 
Event Description
It was reported that a peritoneal dialysis (pd) patient was diagnosed with an infection and potentially peritonitis attributed to a fluid leak from their catheter extension set (unknown catalog #). The patient initially reported that they fell asleep with a pair of scissors in their hands and woke up feeling wet. The patient saw fluid leaking out of their catheter after they cut it on their side of the white clamp. It was initially unknown if the patient was referring to a catheter extension set or their catheter. There was no adverse event, symptom, nor medical intervention reported during the initial call. Upon follow up, the patient's pd registered nurse confirmed the reported event and clarified that it was the extension set that was cut. The leak resulted in an infection and potentially caused the patient's peritonitis. It was reported the patient may have to get their catheter removed. Multiple attempts were made to acquire additional information, however, a response was not received.
 
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Brand NameUNKNOWN- FMC PRODUCT
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
ERIKA DE REYNOSA, S.A. DE C.V.
mike allen #1331
parque industrial reynosa
reynosa 88780
MX 88780
Manufacturer (Section G)
ERIKA DE REYNOSA, S.A. DE C.V.
director, quality systems
1100 e, military hwy, suite c
pharr TX 78577
Manufacturer Contact
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key12067074
MDR Text Key258335235
Report Number8030665-2021-01063
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K904806
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN-FMCPRODUCT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received07/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/25/2021 Patient Sequence Number: 1
Treatment
DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER
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