MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2622-3

Device Problems Leak/Splash (1354); Connection Problem (2900)

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

Event Date 04/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A user facility reported that a blood leak occurred during the hemodialysis treatment.Follow-up information was provided by the nurse manager who revealed that an external blood leak was observed.Reportedly, the bloodline was not threaded properly.However, no crack was visible in the bloodline.The patient¿s estimated blood loss (ebl) was approximately 5-10ml.The nurse manager stated the patient had ¿minimal actual blood loss.¿ no adverse effects were experienced by the patient as a result of this event and no medical intervention was required.The treatment continued with a new set-up on the same machine, and then it was successfully completed without further issue.No machine alarm occurred prior to or after leak observed.No malfunction alleged, identified, or observed with the dialyzer or the 2008k2 hemodialysis machine.The complaint device is not available for evaluation by the manufacturer as it was discarded by the user facility.

Manufacturer Narrative

The device was not returned nor was a companion sample available to the manufacturer for physical evaluation.No malfunction was confirmed during evaluation of the alternate samples returned by the user facility.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 identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lot passed all release criteria.A review of the batch production record did not reveal a probable cause for the customer complaint.There were no non-conformances identified that relate to the reported event, and the reported lot met release criteria.Therefore, the complaint was not able to be confirmed.

• Brand Name: FRESENIUS COMBISET 2008
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5630931
• MDR Text Key: 44887965
• Report Number: 8030665-2016-00211
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 15KR01086
• Other Device ID Number: 00840861100231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2015
• 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: 82 YR
• Patient Weight: 47