MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/SAFE LOCK CATHETER EXT. 12 IN.; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	050-95001
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	06/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
Event or Problem Description
A pertitoneal dialysis (pd) patient reported her catheter piece had fallen out while she was cleaning it.The patient stated she was not connected to the cycler at this time.Follow-up was made with the pd patient's clinic registered nurse (rn), who stated the patient reported that her pd catheter extension had fallen out while the patient was cleaning the area.The pd rn stated the patient used a 12¿ safe-lock catheter adapter, which was replaced.Per pdrn the previous adapter extension was discarded and the lot number was unknown.Per pdrn the patient was required to come into the clinic that morning for fluid culture and the patient was diagnosed with an episode of peritonitis on (b)(6) 2017, as indicated by a highly elevated wbc count.Per pdrn the patient did practice aseptic technique when completing peritoneal dialysis treatments.The pdrn confirmed were no reported fluid leaks during treatment prior to infection.The pdrn stated the patient was not hospitalized for the episodes of peritonitis and was treated in-clinic for fourteen days with vancomycin and tobramycin.Medical records were requested.
Additional Manufacturer Narrative
Conclusion: although a temporal association exists between fresenius products and the peritonitis event there is no documentation that indicates a causal relationship between fresenius products and the etiology of peritonitis.However, the source of peritonitis is possibly related to the catheter extension piece becoming accidentally dislodged by the patient after disconnecting from the cycler machine during her home ccpd therapy.The complaint sample is not available and the lot number of product involved is unknown.Therefore a search of the lots delivered to the patient and clinic was conducted, with a time frame of three months before of the event date and no information was found related to possible lot number from product 050-95001.A device history review was not performed since the lot number is unknown and no information was found from this customer related a possible lot number from product 050-95001.
Event or Problem Description
Documents in the complaint file and medical records were reviewed.On (b)(6) 2017 end stage renal disease (esrd) peritoneal dialysis (pd) patient on continuous cyclic peritoneal dialysis (ccpd) therapy reported ¿her catheter piece had fallen out while cleaning it¿ after disconnecting from the cycler machine during nightly ccpd treatment.On (b)(6) 2017, during a follow up call with the pd patient¿s nurse, the nurse stated a culture of the patient¿s pd fluid was performed and results included a ¿highly elevated white blood cell (wbc) count,¿ and was therefore subsequently diagnosed with peritonitis (unknown signs and symptoms).Additionally, the pd nurse stated that the patient did not require subsequent hospitalization and was started on antibiotic therapy outpatient for 14 days with vancomycin and tobramycin (unknown date, strength, route and frequency).The pd nurse affirmed the patient completeed pd therapy with aseptic technique and there were no reports of fluid leaks during the ccpd treatment prior to the event of peritonitis.Furthermore, the pd nurse reported that the patient¿s signs and symptoms (unknown) of peritonitis had since resolved and the patient continued pd therapy without reported further issues.
Additional Manufacturer Narrative
Conclusion: although a temporal association exists between fresenius products and the peritonitis event there is no documentation that indicates a causal relationship between fresenius products and the etiology of peritonitis.However, the source of peritonitis is possibly related to the catheter extension piece becoming accidentally dislodged by the patient after disconnecting from the cycler machine during her home ccpd therapy.A supplemental medwatch report will be submitted upon completion of the investigation.
Event or Problem Description
Documents in the complaint file and medical records were reviewed.On (b)(6) 2017 end stage renal disease (esrd) peritoneal dialysis (pd) patient on continuous cyclic peritoneal dialysis (ccpd) therapy reported ¿her catheter piece had fallen out while cleaning it¿ after disconnecting from the cycler machine during nightly ccpd treatment.On (b)(6) 2017, during a follow up call with the pd patient¿s nurse, the nurse stated a culture of the patient¿s pd fluid was performed and results included a ¿highly elevated white blood cell (wbc) count,¿ and was therefore subsequently diagnosed with peritonitis (unknown signs and symptoms).Additionally, the pd nurse stated that the patient did not require subsequent hospitalization and was started on antibiotic therapy outpatient for 14 days with vancomycin and tobramycin (unknown date, strength, route and frequency).The pd nurse affirmed the patient completed pd therapy with aseptic technique and there were no reports of fluid leaks during the ccpd treatment prior to the event of peritonitis.Furthermore, the pd nurse reported that the patient¿s signs and symptoms (unknown) of peritonitis had since resolved and the patient continued pd therapy without reported further issues.

• Brand Name: STAY SAFE/SAFE LOCK CATHETER EXT. 12 IN.
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 6649832
• Report Number: 8030665-2017-00344
• Device Sequence Number: 1149768
• Product Code: KDJ
• UDI-Device Identifier: 00840861100767
• UDI-Public: 00840861100767
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K904806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2017

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 050-95001
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: Not provided; 06/29/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 06/29/2017; 07/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PD SOLUTION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR