MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. PATIENT CONNECTOR CLIP (NON-STERILE); SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 04-9100-1

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.

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 13/feb/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

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

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 01/31/2018.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.Sonia 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.

Manufacturer Narrative

A total of 50 companion samples in the original package identified with code (b)(4) and lot number 17pr06003 were received for investigation.A visual inspection was performed with acceptable results.In addition a functional test was performed, and the samples tested worked as intended without any abnormalities during the tested period.The device history file of this product was reviewed and no nonconformance reports or other abnormalities were found.The product involved met specifications.

• Brand Name: PATIENT CONNECTOR CLIP (NON-STERILE)
• 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: 7267697
• MDR Text Key: 99949075
• Report Number: 8030665-2018-00231
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100828
• UDI-Public: 00840861100828
• Combination Product (y/n): N
• PMA/PMN Number: K001873
• 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: 11/30/2019
• Device Catalogue Number: 04-9100-1
• Device Lot Number: 17PR06003
• 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 COMBISET HEMODIALYSIS TUBING; FRESENIUS COMBISET HEMODIALYSIS TUBING; 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 COMBISET HEMODIALYSIS TUBING; 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