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 Pulmonary Embolism (1498); Cardiac Arrest (1762); Death (1802)

Event Date 05/19/2017

Event Type  Death  

Manufacturer Narrative

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

Event Description

The charge nurse at the user facility reported a patient adverse event that occurred soon after the hemodialysis (hd) treatment was initiated.Further event clarification revealed that approximately 10 minutes after initiation of the hd therapy the patient gasped, and then coded.The treatment was cancelled, and the patient was removed from the machine.The code continued for one hour and thirty minutes, after which time, the patient expired.Follow-up information was received which revealed that the event was believed to have been caused by a pulmonary embolism (pe).Although requested, no further patient specific or event related details have been made available.No machine alarms were generated prior to, during, or following the patient incident.Following the event, the unit was removed from service for evaluation.The biomedical technician performed a self-test, and the machine did not pass the optical detect test.Follow-up provided by the biomed revealed that the optical detect issue occurred due to the transducers.The biomed was able to calibrate the venous pressure, arterial pressure, and dialysate pressure transducers to resolve the failed optical detect in self-test during troubleshooting.Following the calibration, the system was restored to full functionality.The unit has been returned to service at the user facility without issue.The dialyzer and bloodline were not available to be returned to the manufacturer for evaluation as both devices were discarded by the user facility.The naturalyte acid concentrate was not available to be returned to the manufacturer for analysis.The bicarb concentrate used for the hd treatment was a non-fresenius manufactured product.

Manufacturer Narrative

Plant investigation: a sample was not returned to the manufacturer for physical evaluation and the lot number or catalog number was not provided.Therefore, the complaint cannot be confirmed.A manufacturing review was performed on the lot numbers for all bloodline products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.A records review was performed on the eight lots identified by the manufacturer.The device history record (dhr) was reviewed on these lots and confirmed that there were no non-conformances or any other occurrence in production identified during the manufacturing process which could be associated with the reported event.All the applicable in-process and final inspection tests were found to be without acceptable results for the eight lots identified in this review.Each of the eight lots identified in this review met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint sample.Clinical investigation: a clinical investigation was performed to identify a causal relationship between the hemodialysis (hd) treatment and the adverse event.Based on the provided information, a temporal relationship exists between the patient ¿coding¿ during hd treatment and the fresenius 2008k2 machine, fresenius dialyzer, fresenius blood line, and fresenius naturalyte.However, any association between the 2008k2 machine or any fresenius products and the adverse event of the patient coding and subsequent expiration cannot be determined based on the lack of information provided.Additionally, there has been no allegation of a machine malfunction or of any malfunction or defect against any fresenius products.

• 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: 6645162
• MDR Text Key: 77684319
• Report Number: 8030665-2017-00335
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• 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
• Date Manufacturer Received: 06/16/2017
• 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
• Patient Outcome(s): Death; Life Threatening; Required Intervention