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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Loss of consciousness (2418)

Event Date 09/11/2017

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

A hemodialysis (hd) patient was undergoing a regularly scheduled hd treatment when the fresenius 2008k2 hd machine alarmed for a blood leak approximately 40 minutes after the treatment started.Blood test strips were used and positively confirmed the presence of blood.The patient¿s treatment was interrupted and the user facility staff replaced the dialyzer with a new one; however, the bloodlines were not replaced at this time.The patient¿s treatment was restarted, however, approximately 45 later, the machine alarmed again for a blood leak.Blood test strips were again used and positively confirmed the presence of blood.In addition, blood was visibly seen in the dialysate.The patient¿s blood pressure (b/p) was 105/69.About 50 minutes later, the patient was found unresponsive.The patient was disconnected from the hd machine and cardiopulmonary resuscitation (cpr) was initiated and automated external defibrillator (aed) was applied to the patient.It was reported by the user facility nurse that the patient did not experience any blood loss.Emergency medical services (ems) transported the patient to the hospital but the patient subsequently passed away.It was stated that the patient went into cardiac arrest prior to passing away but this could not be verified.No malfunction of the fresenius bloodlines in use during the hd treatment was alleged, observed, or reported prior to, during, or following the event.However, the bloodlines device is reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

A clinical investigation was performed to identify a causal relationship between the patient's hemodialysis treatment and the patient passing away.As a death certificate could not be obtained, limited information was available for review.With limited information, the causality of the reported incident could not be determined.There remains a temporal association between the reported adverse events and the use of the bloodlines for hemodialysis treatment.Plant investigation: although the device was returned to the manufacturer for physical evaluation, the lot number could not be identified.Distribution records were reviewed to identify potential lots of this product shipped to the customer for the three (3) month time frame which immediately preceded the event.Batch records for the lots identified were reviewed and confirmed there were no deviations or non-conformances during the manufacturing process.An investigation of the device history records (dhr) was conducted and confirmed that 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.A visual inspection was performed on the returned sample with no issues noted.A simulated therapy was conducted for four hours during which there were no leaks or abnormalities.The sample worked as intended during the testing period.Upon conclusion of the investigation, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 6946527
• MDR Text Key: 89221155
• Report Number: 8030665-2017-00834
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Death; Required Intervention
• Patient Age: 94 YR