MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FMC BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Device Problem Occlusion Within Device (1423)

Patient Problem Blood Loss (2597)

Event Date 09/29/2017

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between the patient¿s reported estimated blood loss of 250 cubic centimeters (cc) and the hemodialysis (hd) treatment on (b)(6) 2017 with the optiflux 180nre dialyzer and fresenius bloodline.The patient¿s blood loss can be causally related to the clotting event within the extracorporeal circuit (ecc) during the hd treatment.However, there is no documentation that supports that a defect with the optiflux 180nre dialyzer or fresenius bloodline caused the clotting event.Adequate systemic anticoagulation is part of the standard of care during hd treatment to reduce the risk of clotting in the ecc.The possibility exists that the patient¿s initial dose of heparin was not sufficient to reduce clotting in the ecc.Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.The lot number and catalog number were not provided, so a search was performed of all fresenius bloodline products shipped to the facility for the three (3) month time frame which immediately preceded the event occurrence date.A records review was performed on a total of 14 lots identified.There are no samples available as the entire lots have been distributed.An investigation of the device history records (dhr) was conducted by the manufacturer.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.In addition, the dhr review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.

Event Description

A nurse at a user facility reported that the optiflux 180nre dialyzer had clotted with blood from the patient¿s venous central venous catheter (cvc) through the end of the dialyzer in the extracorporeal circuit (ecc).The patient received systemic hepatization prior to hemodialysis (hd) treatment with approximately 3,000-4,000 units of heparin.The hd machine dialysate flow rate (dfr) was reportedly 800 with a patient blood flow rate (bfr) of 350 for the hd treatment.In the middle of the patient¿s hd treatment, the fresenius 2008t hd machine incurred a high venous pressure alarm and observation of the ecc revealed visible blood clots.The patient¿s blood was reported to be dark in color in the venous bloodline and venous chamber, and within the dialyzer to the patient¿s cvc port.There were no visible clots on the arterial side of the bloodline.The nurse attempted to reset the venous alarm but the venous pressure did not decrease.The patient¿s hd treatment was interrupted and the patient¿s blood in the ecc was not returned.The estimated blood loss was reportedly 250 cubic centimeters (cc).The patient completed treatment with a new set-up of supplies on the same hd machine and was given an additional 1000 units of heparin bolus directly into the catheter.The patient did not experience any further clotting issues or experience any adverse reactions or symptoms.The reason for the patient¿s blood clotting is not known.There were no observable defects or cracks noticed with the dialyzer or bloodlines used at the time of the event.The complaint device was not available to be returned to the manufacturer for evaluation as it has been discarded at the user facility.

• Brand Name: FMC BLOODLINE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6975701
• MDR Text Key: 90169679
• Report Number: 8030665-2017-00884
• 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
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/25/2017
• 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
• Treatment: FRESENIUS 2008T HEMODIALYSIS (HD) MACHINE; FRESENIUS OPTIFLUX 180NRE DIALYZER
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 104