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

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.

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the lots of catheter extension products shipped to the clinic for three (3) months prior to the event date.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process associated with the reported event.An investigation of the device history records was conducted and confirmed that the results of the in-progress and final quality control testing met all requirements and the lots met all specifications for release.The user guide p/n 480145 was reviewed and indicates "you must use aseptic technique as directed by your pd nurse to prevent infection¿.As per the follow up information received, the incident is attributed to end user error.

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.

• Brand Name: UNKNOWN- FMC PRODUCT
• Type of Device: DIALYZER, 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
• MDR Report Key: 12067074
• MDR Text Key: 258335235
• Report Number: 8030665-2021-01063
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K904806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN-FMCPRODUCT
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 07/02/2021
• Supplement Dates FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID.; DELFLEX PD FLUID.; LIBERTY CYCLER SET.; LIBERTY CYCLER SET.; LIBERTY SELECT CYCLER.; LIBERTY SELECT CYCLER.; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER
• Patient Outcome(s): Other