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

Device Problems Occlusion Within Device (1423); Increase in Pressure (1491)

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

Event Date 05/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No parts were returned to the manufacturer for physical evaluation.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A home hemodialysis nurse reported an incident of blood loss experienced by a (b)(6) female end stage renal disease (esrd) patient receiving at home hemodialysis (hd) treatments.The patient was attempting to initialize the hd treatment, but stated that high venous pressure issues were encountered and were not easily cleared.The system passed all self-tests, however, the venous pressure was noted as being too high (260mmhg).The patient released the pressure from the medication port, and then placed the system into recirculation while blood was in the circuit, in an attempt to stabilize the venous pressure.The unit¿s transmembrane pressure (tmp) readings climbed from 150mmhg to 300mmhg.At the same time, the patient noted that the ¿s¿ clamp on the saline line was not closed, which resulted in blood backing up into the saline bag.Treatment was halted and the blood within the circuit was not returned.The patient proceeded to remove the needles from the access site, and noticed that the venous needle was dislodged.A second attempt was made to set up the machine, however, the machine failed to prime; no saline would circulate through the lines.The patient's doctor administered a hemoglobin (hgb) laboratory test and found the patient's hgb dropped from 111 to 105.The patient¿s estimated blood loss (ebl) was noted as being approximately 250cc, which was the amount lost due to not returning the blood within the extra corporeal circuit.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient was reportedly anxious due to the blood loss, but had no other symptoms.An on-site evaluation of the 2008k at home machine was performed by a fresenius regional equipment specialist (res); no malfunction observed or identified during this testing.The tmp and venous pressures were checked; no issues identified.The complaint device is not available for evaluation by the manufacturer as it was discarded by the patient at the time of the event.

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 dialyzers shipped to this account within the selected time frame.A records review was performed on all 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: FMC BLOODLINES
• 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: 5741403
• MDR Text Key: 48715721
• Report Number: 8030665-2016-00300
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• 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: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: 56 YR
• Patient Weight: 68