MAUDE Adverse Event Report: IRVING MANUFACTURING PLANT GRANUFLO 2251 2K 2.5CA 1MG 16.5 GAL; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Catalog Number	0FD2251-3B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	06/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.Clinical investigation: a clinical investigation was performed by a clinical specialist to identify a causal relationship between the continuous renal replacement therapy (crrt) and the adverse event.The clinical specialist concluded that a temporal relationship exists between the patient¿s cardiac arrest during a crrt treatment performed using a 2008k2 hd machine, a fresenius dialyzer, and fresenius acid and bicarb concentrates.However, any association between the 2008k2 hd machine, the unknown fresenius dialyzer and the acid and bicarb concentrates, and the adverse event of patient coding due to cardiac arrest cannot be determined based on the minimal information received.Additionally, no malfunction was alleged of the 2008k2 hd machine or any other fresenius product in use during the patient¿s hd treatment.
Event or Problem Description
The hemodialysis (hd) nurse at the user facility reported that a female, end stage renal disease (esrd) patient cardiac arrested 32 minutes prior to completion of a regularly scheduled hd treatment.This esrd patient had been utilizing hd therapy thrice weekly for continuous renal replacement therapy (crrt) since (b)(6) 2015.The patients¿ scheduled hd treatment on (b)(6) 2017 was initiated at 05:29.The hd treatment continued through 08:01 with stable vital signs (vs), 2 liter (l) per minute (min) oxygen (o2) via nasal cannula (oxygen is a standing order for patient), with patient resting comfortably throughout hd treatment.At 08:28 the patient was found unresponsive; no pulse or respirations.The patients¿ blood was returned with a normal saline (nacl) bolus (amount unknown).No blood loss occurred.The patient was transferred from the chair to the floor and cardiopulmonary resuscitation (cpr) was performed with an ambu bag.At 08:36, an automated external defibrillator (aed) was attached to the patient and a shock was advised and delivered.Cpr resumed.At 08:38, a radial pulse was palpated.At 08:41, epinephrine [1:1000/1 milliliter (ml)] via intravenous push (ivp) was administered.Emergency medical services (ems) arrived at 08:44 and intubated the patient.The o2 was increased to 15 l/min via ambu bag.An additional nacl bolus (amount unknown) was given by ems, and then the patient was transferred to the hospital via ambulance.At hospital, patient sedated with the following assessment documented.Physical assessment within normal limits with the exception of decreased capillary refill, 1+ pitting edema bilateral lower extremities.The hospital course is unknown.The patient was discharged on an unknown date and has since returned to outpatient hd therapy.A fresenius dialyzer, acid concentrate, bicarb concentrate, and bloodline were in use during the hd therapy.No damage or defects were visible to the dialyzer or bloodline products.No machine alarm was generated prior to the event, and no machine issues were observed prior to, during, or following the treatment.Functional testing was performed on june 13th and then the unit was returned to service on june 14, 2017.The dialyzer was not available to be returned to the manufacturer for analysis as it was discarded by the user facility.No samples of the acid/bicarb were available to be returned to the manufacturer for analysis.
Additional Manufacturer Narrative
A sample was not returned to the manufacturer for physical evaluation.Therefore, the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint sample.A review of the device manufacturing records was performed on the reported lot.There was no indication of product non-acceptance or deviation during the manufacturing process which could be associated with the reported event.The lot passed all release criteria.A definitive conclusion regarding the involvement of the concentrate product could not be reached without a physical analysis of the dialysate used during the reported event.A retrospective review of the batch production record (bpr) failed to identify any non-conformances and/or abnormalities during production that could have caused or contributed to the reported event.Therefore, no evidence of a manufacturing problem exists to substantiate a causal relationship between the concentrate product and the reported event.Granuflo dry acid concentrate is manufactured to meet aami requirements using validated processes, and released based on a determination that the finished product met those requirements.Per the documented product investigation, there was no indication that the granuflo dry acid concentrate product caused, contributed to, or was a factor in the reported event.

• Brand Name: GRANUFLO 2251 2K 2.5CA 1MG 16.5 GAL
• Common Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): IRVING MANUFACTURING PLANT; 5201 regent suite 100; irving TX 75063
• MDR Report Key: 6708961
• Report Number: 1651896-2017-00001
• Device Sequence Number: 16414091
• Product Code: KPO
• UDI-Device Identifier: 00840861101535
• UDI-Public: 00840861101535
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K030497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 0FD2251-3B
• Device Lot Number: 17CTGF009
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 06/12/2017
• Supplement Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 100