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 Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 02/24/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility reported that a blood leak occurred and was observed at the blood pump module during the hemodialysis treatment.Follow-up information was provided by the nurse who revealed that an air detector alarm occurred approximately 30 minutes into the treatment.A 1cm crack was observed in the bloodline tubing which allowed the blood to leak out.The nurse stated that only 5cc of blood was lost to the crack, however, the blood was not transfused back to the patient due to contamination.The patient's estimated blood loss was approximately 200cc.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 was successfully completed without further issue.The complaint device is available for evaluation by the manufacturer.

Manufacturer Narrative

The complaint device was returned to the manufacturer for physical evaluation.A visual examination of the returned device revealed that the pump tubing was torn.A fluid pressure test was performed; fluid leaked from the tear in the material.The reported complaint of a fluid leak in the line was 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.A visual examination of the returned device found the pump tubing was torn.Therefore, the complaint was 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: 5516720
• MDR Text Key: 41242117
• Report Number: 8030665-2016-00136
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 15LR01097
• Other Device ID Number: 00840861100231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2015
• 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: 75 YR
• Patient Weight: 97