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 Migration or Expulsion of Device (1395); Device Slipped (1584)

Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914); Hypovolemia (2243); Loss of consciousness (2418); Blood Loss (2597)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A clinic manager reported approximately two hours into scheduled four hour hemodialysis treatment, patient began coughing.Patient became unresponsive and a moderate amount of blood was noted on the chair, the venous bloodline was noted to be loose from the central venous catheter (cvc) venous limb, and the hemosafe clip was noted to be dislodged from the venous bloodline/cvc limb.The blood pump was turned off and the venous bloodline was resecured to the venus limb of the cvc.500 ml normal saline bolus was administered, oxygen applied.Blood pressure (bp) was 170/91, pulse 109.Staff were unable to arouse patient, who had a weak pulse.Cardiopulmonary resuscitation (cpr) was initiated and 911 was called.Patient became responsive after a few compressions were administered.An additional 500 ml normal saline was given.Ems arrived.Bp was 164/85, pulse 89.The cvc was flushed and capped.The patient was transported to the hospital and was awake, alert and responsive with bp 116/70 upon discharge from facility.Patient was admitted to the hospital and received 2 units of packed red blood cells.He was discharged on (b)(6) 2018.Additional follow-up made with the clinic manager revealed the patient had been coughing throughout treatment, which was reportedly caused by the patient¿s abdominal distension.(b)(6) stated the patient was also prescribed lisinopril to help with the patient¿s hypertension, which may have also contributed to the patient¿s coughing.Per clinic manager it was believed the patient¿s coughing became louder and more severe as treatment progressed, which reportedly caused the lines to dislodge.No visible damage to the connector clip or comibiset set were noted prior to or after the event.The machine did not alarm and the blood pump was turned off.The patient was taken to the hospital and was on a 23 hour hold, and received two blood transfusions while in the hospital.Per clinic manager, the patient was released from the hospital on (b)(6) 2018 and came back in the clinic the following morning to receive another hemodialysis treatment, and stated the patient was able to continue hemodialysis treatments in center without further issue.Per clinic manager the sample was retained and available to be returned for evaluation.

Event Description

Information in the complaint file and received records were reviewed by a post market surveillance clinician.On 02/12/2018, two copies of voluntary medwatch reports were received from a hemodialysis (hd) clinic.The reports, which were previously submitted to the fda for this (b)(6) male patient with end stage renal disease (esrd) on hd for renal replacement therapy (rrt) were submitted to make notification the patient experienced blood loss, loss of consciousness and required medical intervention.During a follow-up call on 02/13/2018 the clinic manager (cm) reported on 01/30/2018 approximately two (2) hours into a scheduled four (4) hour hd treatment, the hemosafe clip was noted to be disconnected from the venous blood line.Additionally it was noted the venous blood line was ¿loose¿ from the dialysis catheter (type and manufacturer unknown) venous lumen.No visual or audible machine alarms were noted.The blood pump was turned off, and the venous blood line was reconnected to the venous lumen of the dialysis catheter.It is unknown if the hemosafe clip was reapplied.Although the exact timeline is unknown, it was reported the patient became unresponsive and a moderate (volume unknown) amount of blood was noted on the dialysis chair.A 500 ml bolus of normal saline (ns) was given and oxygen (mode of delivery and rate unknown) was applied.The cm reported the patient¿s blood pressure (b/p) was 170/91 with a heart rate (hr) of 109 after the ns bolus, however the patient remained unresponsive with a weak pulse (rate unknown).An additional bolus of 500 ml of ns was administered and chest compressions were initiated.After ¿a few¿ (details unknown) chest compressions were administered the patient became responsive (details unknown) with a b/p of 164/85 and hr of 89.Emergency medical services (ems) arrived shortly after the patient regained consciousness, and transported the patient to the emergency room (er).The patient was alert and oriented upon discharge from the outpatient dialysis clinic.Discharge b/p was 116/70.Details regarding the hospitalization and discharge disposition of the patient were unknown, as the discharge summary was currently unavailable.However it was reported the patient was hospitalized for a 23 hour observational admission.During the hospitalization the patient received 2 units of packed red blood cells (prbc).The patient was discharged the following day on (b)(6) 2018 and returned to the outpatient dialysis clinic for an additional hd treatment which occurred without issue.The cm reported on (b)(6) 2018 the patient was coughing during hd therapy which worsened as the treatment progressed.The cm stated the coughing was related to the patient¿s abdominal distension (details unknown).Additionally it was reported the patient was taking lisinopril for hypertension, which could have also contributed to the coughing.

Manufacturer Narrative

Conclusion: a temporal association between the adverse event(s) of the patient¿s blood loss, loss of consciousness and subsequent hospitalization and the fresenius blood lines (custom combi set) and patient connector clip (hemosafe clip) exists.However, there is no documentation or evidence of any defect at the connection site of the venous blood line to the catheter, nor was there any other venous blood line issues leading up to the event that could have caused the loose connection.The exact cause of the catheter and venous blood line becoming unsecured two hours after the initiation of hd therapy is unknown.However, based on the statement made by the cm on (b)(6) 2018 the patient was coughing throughout the hd treatment.As the treatment progressed, the cough worsened in volume and severity and reportedly ¿caused the line to dislodge.¿ it was reported the patient¿s abdominal distention was the cause of the coughing.Additionally, it was reported the patient was prescribed lisinopril for hypertension, which could have also contributed to the coughing as it is a documented side effect.There is no documentation to state if the patient access site was uncovered.Reportedly, a hemosafe clip was placed on the venous line, but it is unknown what make of catheter was utilized and if it was compatible with the hemaclip.The adverse event(s) were a direct result of the patient¿s dialysis venous blood line becoming unsecure and leading to the blood loss, loss of consciousness and subsequent hospitalization.A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

Information in the complaint file and received records were reviewed by a post market surveillance clinician.On (b)(6) 2018, two copies of voluntary medwatch reports were received from a hemodialysis (hd) clinic.The reports, which were previously submitted to the fda for this 61 year old male patient with end stage renal disease (esrd) on hd for renal replacement therapy (rrt) were submitted to make notification the patient experienced blood loss, loss of consciousness and required medical intervention.During a follow-up call on (b)(6) 2018 the clinic manager (cm) reported on 01/30/2018 approximately two hours into a scheduled four hour hd treatment, the hemosafe clip was noted to be disconnected from the venous blood line.Additionally it was noted the venous blood line was ¿loose¿ from the dialysis catheter (type and manufacturer unknown) venous lumen.No visual or audible machine alarms were noted.The blood pump was turned off, and the venous blood line was reconnected to the venous lumen of the dialysis catheter.It is unknown if the hemosafe clip was reapplied.Although the exact timeline is unknown, it was reported the patient became unresponsive and a moderate (volume unknown) amount of blood was noted on the dialysis chair.A 500 ml bolus of normal saline (ns) was given and oxygen (mode of delivery and rate unknown) was applied.The cm reported the patient¿s blood pressure (b/p) was 170/91 with a heart rate (hr) of 109 after the ns bolus, however the patient remained unresponsive with a weak pulse (rate unknown).An additional bolus of 500 ml of ns was administered and chest compressions were initiated.After ¿a few¿ (details unknown) chest compressions were administered the patient became responsive (details unknown) with a b/p of 164/85 and hr of 89.Emergency medical services (ems) arrived shortly after the patient regained consciousness, and transported the patient to the emergency room (er).The patient was alert and oriented upon discharge from the outpatient dialysis clinic.Discharge b/p was 116/70.Details regarding the hospitalization and discharge disposition of the patient were unknown, as the discharge summary was currently unavailable.However it was reported the patient was hospitalized for a 23 hour observational admission.During the hospitalization the patient received 2 units of packed red blood cells (prbc).The patient was discharged the following day on (b)(6) 2018 and returned to the outpatient dialysis clinic for an additional hd treatment which occurred without issue.The cm reported on (b)(6) 2018 the patient was coughing during hd therapy which worsened as the treatment progressed.The cm stated the coughing was related to the patient¿s abdominal distension (details unknown).Additionally it was reported the patient was taking lisinopril for hypertension, which could have also contributed to the coughing.

Manufacturer Narrative

Plant investigation: the sample was received without the original package for investigation.During the evaluation of the actual sample the alleged failure stated in the complaint was not confirmed.The male conical fitting of the venous patient connector was dimensionally inspected using ansi male gauge and was found acceptable.In addition a functional test was performed to the sample received with acceptable results.The fluid flowed through the line and no leaks or air bubbles were observed and no level variation of venous or arterial drip chamber was observed that indicate the introduction of air into the blood circuit.A device history review was performed on the potential related lot.No nonconformance reports or other abnormalities during the assembly of the lot was found.The product involved met specifications.

• 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
• MDR Report Key: 7267694
• MDR Text Key: 99948285
• Report Number: 8030665-2018-00232
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2020
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 17KR01196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Device Age: MO
• Date Manufacturer Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 100 DEXTROSE; 100 DEXTROSE; 2.0 CA, 1.0 MG; 2.0 CA, 1.0 MG; AMLODIPINE; AMLODIPINE; ASA; ASA; ASPIRIN; CARVEDILOL; CARVEDILOL; FRESENIUS 1000ML NORMAL SALINE; FRESENIUS 1000ML NORMAL SALINE; FRESENIUS 160NRE DIALYZER; FRESENIUS 160NRE DIALYZER; FRESENIUS 2008T HEMODIALYSIS MACHINE; FRESENIUS 2008T HEMODIALYSIS MACHINE; FRESENIUS HEMACLIP; FRESENIUS HEMACLIP; GLIDEPATH LONGTERM CVC TUNNELED CATHETER; GLIDEPATH LONGTERM CVC TUNNELED CATHETER; GRANUFLO 2.0K; GRANUFLO 2.0K; LISINOPRIL; LISINOPRIL; METFORMIN; METFORMIN; NATURALYTE 4000RX12 BICARBONATE; NATURALYTE 4000RX12 BICARBONATE; AMLODIPINE; ASA; CARVEDILOL; FRESENIUS 1000ML NORMAL SALINE; FRESENIUS 160NRE DIALYZER; FRESENIUS 2008T HEMODIALYSIS MACHINE; FRESENIUS HEMACLIP; GLIDEPATH LONGTERM CVC TUNNELED CATHETER; GRANUFLO 2.0K; LISINOPRIL; METFORMIN; NATURALYTE 4000RX12 BICARBONATE; THE 100 DEXTROSE; THE 2.0 CA, 1.0 MG
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 69