MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2722-9

Device Problems Fluid/Blood Leak (1250); Misconnection (1399)

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

Event Date 01/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for physical evaluation.A plant investigation is still ongoing and a supplemental report will be submitted upon completion.

Event Description

An inpatient user facility reported during a patient's treatment the heparin line became separated from the dialysis line.The machine alarmed appropriately when the separation occurred.The separation occurred near the end of therapy and the patient did not resume treatment on the machine.The estimated blood loss was 200ml.The patient did not experience adverse effects and no medical intervention was required.

Manufacturer Narrative

The complaint device was returned to the manufacturer for physical evaluation.A visual examination of the returned device revealed that the heparin line was separated from the arterial line pump tee connector.Further analysis found that the heparin line separated from the arterial line due to the lack of solvent in the heparin line tube.No additional evaluation methods were required as the reported complaint of ¿heparin line separated from dialysis line¿ was able to be confirmed.A records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.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.The investigation into the cause of the reported problem was able to confirm the failure mode.The heparin line separation observed during the visual examination would have resulted in the blood leak.Therefore, the complaint event was confirmed.

• Brand Name: CUSTOM COMBI SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; erika de reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): REYNOSA PLANT; erika de reynosa,s.a. de c.v.; mike allen 1331 parque ind.; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5444028
• MDR Text Key: 38998325
• Report Number: 8030665-2016-00070
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 15PR01021
• Other Device ID Number: 00840861100293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2015
• 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: 92 YR