MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/LUER LOCK CATHETER EXT. 18 IN.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 050-95005

Device Problem Fluid/Blood Leak (1250)

Patient Problem Peritonitis (2252)

Event Date 03/28/2019

Event Type  Injury  

Manufacturer Narrative

Clinical review: a clinical investigation was performed.Based on the available information, the fresenius safe lock 18-inch tubing set cannot be excluded as a causal/contributory factor in the patient¿s peritonitis event.Anytime there is a breach in the aseptic pd pathway there is a risk of contamination with bacteria that can lead to a peritonitis infection in pd patients.At this time, it cannot be determined what exactly caused the fluid leak to occur with this product as the manufacturer product investigation is currently pending.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis (pd) nurse reported to fresenius customer service that a stay safe luer lock has droplets all over the tubing at the end of treatment, it appears to have no issue until pressure is applied.The pdrn stated the patient discontinued treatment due to fluid on their bed.The patient was prescribed antibiotics and a culture of the fluid was taken.Upon follow up, the peritoneal dialysis nurse (pdrn) confirmed the fluid leak.The pdrn stated that the fluid leak came from the stay safe luer lock between the line segment.The pdrn stated that the patient developed peritonitis from the fluid leak that occurred during fill and drain phases of the patient¿s peritoneal dialysis treatment.The patient was not hospitalized.The pdrn stated that the patient experienced the fluid leak on (b)(6) 2019 and presented in the clinic on (b)(6) 2019.The patient has cloudy effluent.The pdrn stated that a pd culture was performed.The pdrn stated that the organism was staphylococcus epidermidis.The patient was prescribed vancomycin (2 grams, intraperitoneal) and oral cipro, 500mg once a day.The pdrn stated that the patient is continuing treatment on the cycler.The pdrn stated the sample was available for return for physical evaluation by the manufacturer.

Manufacturer Narrative

Correction: common device name and labeled for single use.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.During the evaluation of the actual sample was found pin holes in the tubing.The reported event was confirmed during sample evaluation.The device history record (dhr) of this product was reviewed and no nonconformance reports or other abnormalities during the assembly of this lot were found.In addition, the complaint database was queried and no additional complaints with the same failure mode have been received from this lot.Additionally, a shipping search was performed of the alleged lot number delivered date and was found that the customer received since 10/18/18.

• Brand Name: STAY SAFE/LUER LOCK CATHETER EXT. 18 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: 8496870
• MDR Text Key: 141374085
• Report Number: 8030665-2019-00562
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100798
• UDI-Public: 00840861100798
• 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,Followup
• Report Date: 05/17/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-95005
• Device Lot Number: 18ER08109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Device Age: MO
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 05/15/2019; 05/17/2019
• Supplement Dates FDA Received: 05/16/2019; 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET ; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 82