MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA COMBI SET 8MM PRE 2 VENOUS INJECT SITES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2922-7

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility reported that a bloodline blood leak was observed at the location of the pump segment a few minutes after the patient's hemodialysis (hd) treatment was initiated.The patient's estimated blood loss (ebl) was reported as being approximately 100cc.No complications or adverse patient effects occurred as a result of this event and no medical intervention was required.The patient was able to successfully complete their treatment using a new bloodline on the same 2008k2 hd machine.No bloodline damage was visible; however, follow-up information was provided which revealed that a small amount of rinse back fluid leaked from the far right end of the pump segment when it was squeezed.Additional follow-up revealed that no machine malfunctions were observed or identified at the time the incident occurred.Following the event, the blood pump rotor and internal blood pump housing were inspected and found to be intact.The 2008k2 hd machine remains in use at the user facility.The complaint device is not available for evaluation by the manufacturer as it was discarded by the user facility.

Manufacturer Narrative

The reported complaint is not confirmed as the complaint device was not available for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.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.Review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.

• Brand Name: COMBI SET 8MM PRE 2 VENOUS INJECT SITES
• 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: 5702812
• MDR Text Key: 47910524
• Report Number: 8030665-2016-00270
• 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: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 03-2922-7
• Device Lot Number: 15JR01002
• Other Device ID Number: 00840861100323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2015
• 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: 81 YR
• Patient Weight: 76