MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87216

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow up mdr will be submitted upon completion of the plant investigation.

Event Description

The patient's peritoneal dialysis registered nurse (pdrn) called stating that the patient had contacted her indicating that when he stripped down his cycler in the morning, he had discovered moisture in the cycler's cassette compartment.Upon follow up with the patient it was determined that antibiotics were prescribed as prophylactic.However, the patient had not experienced any adverse events as a result of this incident.An effluent culture test was also performed and the results were (b)(6).The sample was made available for return; thus, a ship kit was sent to the patient to have the sample returned to the manufacturer for an evaluation.

Manufacturer Narrative

The actual sample and a companion sample were received from the patient for evaluation and the complaint was confirmed.The samples were received without the original package and the lot number is unknown.A visual inspection was performed to both samples received.In the actual sample inspection the alleged failure was confirmed, a pin hole was found in the cassette membrane.The visual inspection of the companion sample was performed with acceptable results.Simulated use testing of the companion sample was performed with acceptable results.Device history review (dhr) review was performed on potential related lots.No nonconformance reports or other abnormalities during the assembly of these lots were found.The product involved met specifications.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• 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.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6447967
• MDR Text Key: 71326558
• Report Number: 8030665-2017-00144
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 03/30/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DELFLEX PD SOLUTION; LIBERTY CYCLER
• Patient Age: 64 YR
• Patient Weight: 104