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

Model Number	050-95005
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered fluid leaking between the catheter and transfer set.The patient reported receiving an m31 air detected in cassette alarm during an unknown fill stage of treatment.The cycler was rebooted and patient received the mwd watchdog timer error.It is unknown at which point in therapy the leak may have begun.Upon follow up, the pdrn reported the leak was due to a loose transfer set.The patient reported the leak was from the catheter not the cycler set cassette.It was confirmed that the patient was able to complete peritoneal dialysis treatment.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient was prescribed 1750 mg vancomycin and 2000 mg ceftazidime one time orders as a precaution.The patient is continuing peritoneal dialysis therapy with no further issues.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered fluid leaking between the catheter and transfer set.The patient reported receiving an m31 air detected in cassette alarm during an unknown fill stage of treatment.The cycler was rebooted and patient received the mwd watchdog timer error.It is unknown at which point in therapy the leak may have begun.Upon follow up, the pdrn reported the leak was due to a loose transfer set.The patient reported the leak was from the catheter not the cycler set cassette.It was confirmed that the patient was able to complete peritoneal dialysis treatment.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient was prescribed 1750 mg vancomycin and 2000 mg ceftazidime one time orders as a precaution.The patient is continuing peritoneal dialysis therapy with no further issues.
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.The catheter extension was not received however a cycler set cassette was returned.The sample received was visually inspected and was found that the cycler set is acceptable no damage was observed on the patient connector.No information was found in the system from this customer regarding the product.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.
Additional Manufacturer Narrative
Correction: h.6.
Event or Problem Description
It was reported that a peritoneal dialysis (pd) patient discovered fluid leaking between the catheter and transfer set.The patient reported receiving an m31 air detected in cassette alarm during an unknown fill stage of treatment.The cycler was rebooted and patient received the mwd watchdog timer error.It is unknown at which point in therapy the leak may have begun.Upon follow up, the pdrn reported the leak was due to a loose transfer set.The patient reported the leak was from the catheter not the cycler set cassette.It was confirmed that the patient was able to complete peritoneal dialysis treatment.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient was prescribed 1750 mg vancomycin and 2000 mg ceftazidime one time orders as a precaution.The patient is continuing peritoneal dialysis therapy with no further issues.

• Brand Name: STAY SAFE/LUER LOCK CATHETER EXT. 18 IN.
• Common Device Name: 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
• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13656258
• Report Number: 8030665-2022-00206
• Device Sequence Number: 16764445
• Product Code: KDI
• UDI-Device Identifier: 00840861100798
• UDI-Public: 00840861100798
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K904806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 050-95005
• Device Catalogue Number: 050-95005
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 03/04/2022; 03/27/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 03/24/2022; 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Patient Sex: Unknown