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

Catalog Number 03-2722-9

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 12/31/2017

Event Type  Death  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between the patient becoming unresponsive without a carotid pulse, leading to the patient¿s expiration, and the fresenius 2008t hemodialysis (hd) machine, optiflux 160nre dialyzer, and combi set.However, there is no documentation to support a causal relationship between the 2008t machine, optiflux 160nre dialyzer, or combi set and the adverse events of the patient becoming unresponsive and subsequent expiration.There were no reported machine alarms or malfunction of during the hd treatment.Additionally, the machine passed all ultrafiltration (uf) functional testing and was released back into service on 01/11/2018.The patient expired as the result of no resuscitation efforts as the patient was a ¿do not resuscitate¿ (dnr).However, the patient¿s history of small oat cell cancer and the cause of death listed as acute myocardial infarction were contributing factors leading to the expiration.The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

An area technical operations manager (atom) for a user facility reported that a patient expired during a regularly scheduled hemodialysis (hd) treatment while on a fresenius 2008t hd machine.Pre-dialysis vital signs were reported as follows: blood pressure (b/p) sitting 154/68, unable to obtain standing b/p, pulse 90 and regular, respirations 22, temperature 96.8°f, pre-weight (b)(6) (3kg weight gain); the patient complained of shallow breathing with breath sounds of rales/crackling left and right upper lobe/rales, lung congestion and shortness of breath (sob) on exertion, and the patient appeared anxious, pleasant, lower leg and ankle edema bilaterally reported 1+: 2mm or less, disappears rapidly.Additionally, it is reported the patient complained of prior injury (details were not reported).According to the nurse, who was also the patient¿s caregiver, the patient did not have any symptoms or complaints during treatment the hd treatment was initiated at 08:35am without any issues; the patient was alert; b/p 158/57, pulse 90, oxygen via nasal cannula 2 liters/minutes; blood flow rate (bfr) at 400, dialysate flow rate (dfr) at 600.At 08:50am, the patient reported as unresponsive with no carotid pulse, ashen in color.Hd treatment was terminated.A notation on the hd treatment sheet stated that the patient had small oat cell cancer and was currently on chemotherapy.The patient was verified to be a ¿do not resuscitate¿ (dnr); therefore, no resuscitation effort was performed.The staff called emergency medical services (ems), who arrived on-site at 09:00am.Ems called the coroner at 09:05am while the patient was transferred from the treatment floor and placed in an examine room.The coroner pronounced the patient dead.The clinic manager reported that the patient¿s cause of death was metastatic lung cancer; however, the end stage renal disease (esrd) death notification form listed the patient¿s cause of death as acute myocardial infarction with no secondary cause.It was reported that there was no machine alarms and no indication of any malfunction or defect concerning any fresenius products used during the patient treatment.Following the event, the machine was removed from service for evaluation.A fresenius regional equipment specialist (res) performed on-site service on (b)(6) 2018.The res completed the ultrafiltration (uf) function tests and found no failures.The res confirmed that the machine functioned per specifications and completed all functional checks.The machine was returned to service at the user facility on 01/11/2018.No disposable devices are available to be returned to the manufacturing plants for physical evaluation as they have been discarded.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not available for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A records review was performed on the reported lot.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 lot met all specifications for release.A review of the dhr did not reveal a probable cause for the reported event.

• Brand Name: CUSTOM COMBI SET
• 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: 7215652
• MDR Text Key: 98088232
• Report Number: 8030665-2018-00126
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• 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: 02/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 17LR01168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2017
• 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 MACHINE; FRESENIUS GRANUFLO 2251; FRESENIUS OPTIFLUX DIALYZER
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Weight: 79