MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 050-95004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Peritonitis (2252)

Event Date 08/15/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: a temporal relationship exists between the pd therapy with the fresenius pd extension set and the patient¿s peritonitis.However, there is no objective evidence that a fresenius pd extension set malfunction or product deficiency was associated with this event.The patient¿s peritonitis can be reasonably attributed to a breach in aseptic technique as it was reported the patient was not capping the pd catheter end after pd treatment and reused the fresenius extension set against instructions for use.

Event Description

It was reported that a patient was admitted to the hospital for peritonitis.Upon follow up with the pdrn, it was reported that the patient contaminated the pd catheter end by not capping the pd catheter end after pd treatment and was reusing the fresenius extensions set against instructions for use.As a result, the pd nurse obtained a pd effluent culture in the outpatient pd clinic on (b)(6) 2019 which yielded an elevated white blood cell (wbc) count of 561.The patient was treated on an outpatient basis with cefazolin 1 gram and ceftazidime 1 gram intra-peritoneal (ip) for 21 days.The patient recovered fully from this event.The pdrn stated the patient was re-educated multiple times on not reusing the extension set and using a pd catheter cap at the end of very treatment.

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 products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius extension sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformance's or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr 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.

• Brand Name: STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.
• 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: 9185632
• MDR Text Key: 162369180
• Report Number: 8030665-2019-01584
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100781
• UDI-Public: 00840861100781
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

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: 050-95004
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 10/11/2019
• Supplement Dates FDA Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR