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

Catalog Number 03-2621-5

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

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

Event Date 05/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No parts were returned to the manufacturer for physical evaluation.The plant investigation is on-going.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

A user facility reported a blood loss event that occurred during a patient's routine hemodialysis (hd) treatment.This report concerns a (b)(6), female patient with end stage renal disease (esrd) on long term hemodialysis.The nurse reported that the patient was currently admitted to the hospital for unrelated issues.Furthermore, the patient arrived to the user facility with a known gi bleed.Therefore, heparin was not administered prior to the initiation of therapy.Approximately 25 minutes into the hd treatment, the patient's blood began to exhibit signs of clotting and the machine alarmed for high pressure.The treatment was halted, and a rinse-back of the patient's blood in the extra corporeal circuit was attempted.However, during rinse-back, pressure built up in the blood line, causing blood to fill the saline line.As a result of the clotting and pressure build up issues, approximately 200cc of blood could not be returned.Per the nurse's clinical assessment, the patient's access (graft) was deemed in poor condition.Therefore, after the patient was switched to another machine, the arterial and venous needles were stuck in a different location on the graft, above the original access site.The treatment was restarted, and was able to be successfully completed with no further issues.No damage to the dialyzer or bloodline was visible.Per the nurse, no malfunctions alleged, observed, or identified with the 2008k2 hemodialysis (hd) machine.Following this event, the unit remained in service, fully operational and without issue.During the entire event, the patient was noted as being stable and asymptomatic.The dialyzer and bloodline are not available for evaluation by the manufacturer as both devices were 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.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 bloodline tubing sets shipped to this account within the selected time frame.A records review was performed on each identified 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.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.Therefore, the complaint was not able to be confirmed.

• Brand Name: CUSTOM COMBI SET W/SPLIT SEPTUM
• 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: 5739220
• MDR Text Key: 48060088
• Report Number: 8030665-2016-00297
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2621-5
• Other Device ID Number: 00840861100224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2016
• 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: 75 YR
• Patient Weight: 56