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

Catalog Number 03-2722-9

Device Problems Occlusion Within Device (1423); Pressure Problem (3012)

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

Event Date 05/27/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility reported that a 2008t hemodialysis machine's transmembrane pressure (tmp) became stuck low positive during a patient's hemodialysis treatment.The patient's treatment was stopped and blood was returned to the patient.The patient was transferred to an alternative machine.During the return of blood, the patient experienced a blood loss of approximately 50cc.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The manufacturer's regional equipment specialist (res) inspected and tested the machine post event.The res was not able to duplicate the tmp stuck low issue.As a precautionary measure, the res replaced the dialysate pressure transducer and recalibrated dialysate pressure and venous pressure.Functional testing performed by the res confirmed the unit was operating properly.The unit was returned to service at the user facility without issue.The bloodline product is not available for evaluation by the manufacturer as it was discarded by the user facility.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A manufacturing review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius bloodlines from the reported catalog number (03-2722-9) shipped to this account within the selected time frame.A records review was performed on the three (3) lots identified.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 lots passed all release criteria.A review of the batch production records did not reveal a probable cause for the customer complaint.There were no non-conformances identified that relate to the reported event, and all lots met release criteria.

• Brand Name: COMBISET TRUE FLOW
• 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: 5746455
• MDR Text Key: 48828205
• Report Number: 8030665-2016-00313
• 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: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Other Device ID Number: 00840861100293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2016
• 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: 62 YR
• Patient Weight: 90