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
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Death (1802); Hypovolemia (2243); Loss of consciousness (2418); Blood Loss (2597)
Date of Event	10/17/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Clinical investigation: a temporal association with the adverse events of the patient¿s blood loss, cardiopulmonary arrest, and eventual death and the fresenius blood lines and hemaclip exist.However, there is no documentation of any defects at the connection site of the venous blood line to the catheter or any other venous blood line issues leading up to the event that would cause the loose connection.Additionally, it was reported that the machine did not alarm.It is unknown what may have occurred to cause the catheter and venous blood line to become unsecure an hour and a half after the initiation of hemodialysis (hd) therapy.There is no documentation to state if the patient access site was uncovered.Reportedly, there were hemaclips placed on both the arterial and venous lines, but it is unknown what kind of catheter was utilized and if it was compatible with the hemaclips.The adverse event was a direct result of the patient¿s dialysis venous line becoming unsecure and detaching from the catheter connection leading to the blood loss, cardiac arrest, and death.The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.
Event or Problem Description
On (b)(6) 2017, approximately one and a half hours into a scheduled four hour hemodialysis (hd) treatment, blood was noted on the floor to the right of the patient¿s chair.This was observed during a random check by a staff member as the previous patient check at an unknown time was uneventful with no patient complaints or symptoms.The venous bloodline was detached from the venous lumen of the central venous catheter.The machine did not alarm.The blood pump was stopped and the lumen was clamped.The patient was unresponsive.The estimated blood loss (ebl) was reported to be between 100-300ml and the nurse stated that the patient became unresponsive due to the blood loss.The staff administered oxygen, the automated external defibrillator (aed) was applied, cardiopulmonary resuscitation (cpr) was initiated, and 911 was called.Normal saline was infused via the patient¿s arterial line.The patient was transported to the hospital via emergency medical services (ems) and later expired.The hemaclips were applied to both arterial and venous lines at the initiation of the patient¿s treatment.The cause of death is stated as cardiopulmonary death and hypovolemia.It is unknown how the bloodline became disconnected from the catheter.There was no observed malfunction or defect with the bloodline or hemaclip.Following the event, the machine was evaluated by the user facility biomedical engineer (biomed).The biomed found no machine issues and verified operations.The machine was returned to service at the user facility without a recurrence of the event as reported.The bloodlines were reported to be available to be returned to the manufacturer for physical evaluation.The hemaclips were not available to be returned.
Additional Manufacturer Narrative
Device evaluation: 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.Per the instructions for use (ifu g71-3906), it states that the device does not work with all catheter types and to contact the catheter manufacturer to determine if the device is compatible before use.The ifu contains steps for the connection of the product.The ifu is included in the product packaging and explains proper connection and disconnection steps.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 results were acceptable.The lot met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.
Event or Problem Description
Additional information regarding the patient's hemodialysis (hd) treatment was received.The patient's blood flow rate (bfr) was 400 ml/min and the dialysate flow rate (dfr) was 800 ml/min.The patient's access was not covered.The patient's bloodlines had not been manipulated by the staff or the patient at any time after the initiation of treatment.The venous bloodline had completely disconnected from the catheter and was found on the floor.The hemaclip had not been able to be located.

• Brand Name: PATIENT CONNECTOR CLIP (NON-STERILE)
• Common Device Name: 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: 7046768
• Report Number: 8030665-2017-01002
• Device Sequence Number: 1411227
• Product Code: FJK
• UDI-Device Identifier: 00840861100828
• UDI-Public: 00840861100828
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K001873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 04-9100-1
• Device Lot Number: 17HR06011
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008T MACHINE; FRESENIUS COMBI SET BLOODLINES; FRESENIUS OPTIFLUX 180NRE DIALYZER; MEDCOMP CENTRAL VENOUS CATHETER
• Outcome Attributed to Adverse Event: Death
• Patient Age: 54 YR
• Patient Weight: 111