MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE REYNOSA MANUFACTURING LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87216

Device Problems Migration or Expulsion of Device (1395); Reflux within Device (1522); Use of Device Problem (1670)

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

Event Date 02/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The pd set has not yet been returned for evaluation.A follow up mdr will be submitted following device evaluation.

Event Description

A peritoneal dialysis (pd) patient reported an occurrence of drain complication alarm observed during drain 2 of 2 of treatment.The patient reported the cycler was filling the heater bag on the cycler from the drain line which was placed in a toilet.He reported the cassette's drain line and heater bag line were attached firmly, but were connected in the wrong position on the pd cycler cassette.The patient promptly discontinued treatment and switched to a manual exchange.The patient subsequently reported feeling unwell and was administered prophylactic cefzolin antibiotic therapy for prevention of peritonitis, pd therapy continues unchanged.The patient has retained the set but stated he will make it available for evaluation.During follow up the patient reported the cycler had additional alarms during treatment but he was able to bypass them.He observed the heater bag had more fluid present than he had started pd therapy and the end of the drain line had been submerged in the toilet water.The patient had checked the other sets in the same box and had found the other companion sets did not have the same alleged product defect.During follow up the patient's pd nurse reported the patient was negative for any symptoms of infection.The patient provided the set into the clinic and the nurse reported the lines appeared to be incorrectly placed.Photos were taken and made available for evaluation.Pd effluent and blood cultures were reported negative for infection.The nurse reported the patient was retrained from not submerging the end of the pd drain line into the toilet water.

Manufacturer Narrative

Device was not made available for evaluation.The device was not returned to the manufacturer for physical evaluation despite numerous attempts the patient chose to retain the set.The lot number was not able to be obtained to date.Distribution records were reviewed to identify potential lots of this product shipped to the customer over the past 3 months.The entire set of lots have been sold and distributed.Batch records for the lots identified were reviewed and confirmed there were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.Pictures were received of the set from the patient's nurse.It can be observed that the lines are inverted in the organizer; however the rest of the lines are not visible to confirm that the lines are assembled in the incorrect cassette ports and not just misplaced in the organizer.Based on the complaint description it could be determined that the lines from the drain line (yellow clamp) and the heater bag line (red clamp) were inverted.The heater bag line was assembled in the port for the drain line and vice versa.A functional test was performed to replicate the alleged incident, a liberty set code 050-87216 was used and intentionally was modified the assembly of drain line to the heater bag line, the lines were inverted.The drain line end was placed on the beaker simulating the toilet and submerged in the red water mixture to simulate the condition of the alleged incident.Note: in accordance with the user guide p/n 480068 states ¿do not submerge the end of the drain line in liquid such as a toilet bowl¿.If properly following instructions to not break the cones of the supply bag early the setup could not be completed.The system alarms for drain line blockage and will not progress.It is possible to continue with the treatment only if the patient broke the cones prematurely.A second test was performed to try get to the drain 2 where the patient reported he noticed the issue, the test was performed using the parameters from the first test.During setup the cycler alarmed for the heaterbag not being detected but this alarm could be bypassed.During the treatment phase the cycler alarmed repeatedly for a scale reading error, as designed.These alarms could be bypassed but occurred more than 10 times before reaching drain 2.Testing determined that if the lines were transposed as described there were multiple use errors and bypassed alarms before reaching the treatment stage as described by the patient.Without the set being made available or better pictures further evaluation is not possible.The complaint cannot be confirmed.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): FRESENIUS MEDICAL CARE REYNOSA MANUFACTURING; erika de reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): REYNOSA; erika de reynosa, s.a.; parque industrial reynosa; reynosa, tamaulipas. cp 88780 ; MX 88780
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5535077
• MDR Text Key: 41771754
• Report Number: 8030665-2016-00153
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Other Device ID Number: 00840861100750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 47 YR
• Patient Weight: 80