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 Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem Blood Loss (2597)

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A hemodialysis clinic manager reported approximately three and a half hours into a hemodialysis (hd) treatment approximately 200-300 ml of blood was noted on the floor during the patient's treatment.The hd patient was noted to be alert and patient's blood pressure was 184/205.The patient was administered 1500 ml of saline, ems was notified and patient was transported to the hospital.Vital signs upon discharge for the patient's blood pressure was 184/205, and pulse 107.The clinic staff reported that the connection between the venous blood line and the fistula needle was loose.Additional follow-up was made with the clinic charge nurse, who stated the patient¿s dialysate flow rate (dfr) was 800 and the patient¿s blood flow rate (bfr) was 400.The charge nurse stated the leak was noted as being an external blood leak at the venous blood line and the fistula needle.No visual damage to the bloodline was observed.The patient¿s estimated blood loss (ebl) was confirmed to be between 200 and 300ml.The charge nurse stated the treatment was stopped immediately after the blood leak was noted, the patient was administered 1500ml of saline.The patient was transported to the hospital emergency room as a precaution due to the blood loss and the patient was released from the hospital without formal admission.Per charge nurse the patient was able to resume hemodialysis treatment the following treatment without further issue.The sample was discarded.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, and the lot number was not able to be obtained to date.Distribution records were reviewed to identify potential lots of this product shipped to the customer over the past 3 months.The entire set of lots have been sold and distributed.Batch records for the lots identified were reviewed and confirmed there were no deviations or nonconformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A hemodialysis clinic manager reported approximately three and a half hours into a hemodialysis (hd) treatment approximately 200-300 ml of blood was noted on the floor during the patient's treatment.The hd patient was noted to be alert and patient's blood pressure was 184/205.The patient was administered 1500 ml of saline, ems was notified and patient was transported to the hospital.Vital signs upon discharge for the patient's blood pressure was 184/205, and pulse 107.The clinic staff reported that the connection between the venous blood line and the fistula needle was loose.Additional follow-up was made with the clinic charge nurse, who stated the patient¿s dialysate flow rate (dfr) was 800 and the patient¿s blood flow rate (bfr) was 400.The charge nurse stated the leak was noted as being an external blood leak at the venous blood line and the fistula needle.No visual damage to the bloodline was observed.The patient¿s estimated blood loss (ebl) was confirmed to be between 200 and 300ml.The charge nurse stated the treatment was stopped immediately after the blood leak was noted, the patient was administered 1500ml of saline.The patient was transported to the hospital emergency room as a precaution due to the blood loss and the patient was released from the hospital without formal admission.Per charge nurse the patient was able to resume hemodialysis treatment the following treatment without further issue.The sample was discarded.

Manufacturer Narrative

Conclusion: a temporal association exists between the reported loose connection between the venous combi set blood line and the patient¿s venous sysloc fistula needle (not a fresenius product) and the pt¿s blood loss of approximately 200-300 ml.However, based on the available information it is unknown what may have occurred to cause the loose connection between the combi set blood line and the sysloc needle (not a fresenius product).Although it was reported there were no visual damage with the combi set blood line in question.The product was not available for plant investigation.Should additional information become available this clinical investigation will be re-evaluated accordingly.

Event Description

Information in the complaint file was reviewed by a post market surveillance clinician.On 11/21/2017, a copy of a voluntary medwatch previously submitted to the fda by a user for an adverse event involving the combi set blood line was received.The report concerned this patient on hemodialysis (hd) for renal replacement therapy (rrt) making notification that on (b)(6) 2017 approximately 3 ½ hours into the patient¿s four hour hd treatment (using the 2008 t machine and combi set blood lines with a blood flow rate of 400 milliliter (ml)/ minute (min) and dialysate flow of 800 ml/min), it was observed by a patient care technician that patient blood on the floor.It is estimated the patient lost approximately 200-300 milliliters (ml) of blood.It was reported there was a loose connection between the combi set venous blood line and the patient¿s venous sysloc fistula needle (not a fresenius product).There were no reported machine alarms when the incident occurred.The patient was treated at the outpatient hd clinic with the administration of 1500 milliliter (ml) normal saline (per physician order) and the patient¿s treatment was ended.Additionally (as a precaution), the patient was sent to the hospital via emergency medical services (ems).The patient¿s vitals upon discharge from the hd clinic were blood pressure (bp) 184/105 and pulse (p) 107 and patient was alert and oriented per nursing assessment.The details surrounding the emergency room encounter were unknown.The patient did not require hospital admission.Additionally, the patient¿s hemoglobin (hgb) was 9.8 prior to hd treatment on 8/nov/2017 and after the blood loss incident the patient¿s hgb decreased to 8.5.Treatment for the patient¿s drop in hgb was unknown.The patient was able to resume his next regularly scheduled outpatient hd treatment on (b)(6) 2017 without further reported issue.The 2008t machine was pulled from service and tested after the event with out reported repairs.The machine was returned into service without further reported issue.Additionally, it was reported there were no visual defects with the combi-set bloodline.The combi set blood line was discarded and not available to be returned for evaluation.

• 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: 7064074
• MDR Text Key: 93104456
• Report Number: 8030665-2017-01038
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 03-2722-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 11/28/2017
• Supplement Dates Manufacturer Received: 12/11/2017; 12/12/2017
• Supplement Dates FDA Received: 12/12/2017; 12/13/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Weight: 68