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 Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Cardiac Arrest (1762); Death (1802); Exsanguination (1841); Blood Loss (2597)

Event Date 12/29/2017

Event Type  Death  

Manufacturer Narrative

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

Event Description

A hemodialysis (hd) patient was scheduled for regular dialysis treatment and hemodialysis was initiated via left upper avg utilizing two #15 gauze needles.Treatment was initiated at approximately 1:09pm for a four hour treatment.At approximately 3:10pm, the patient appeared to be in distress and was placed in trendelenburg position.Blood was noted in the patient's chair and the patient was unresponsive.No reported audible machine alarm was noted.Normal saline was administered via venous line, and normal saline was noted seeping through the arterial line.The tape and 2x2 gauze which was placed over both needle sites was removed.The staff reported the arterial and venous needles were dislodged when they removed the tape, as evident by the saline bolus dispersing onto the patient and her belongings instead of into the vascular system as intended.The patient's access site was not covered during hemodialysis.The staff didn't report the need to manipulate the venous or arterial needles during dialysis; pressures documented on the treatment sheet were stable and within range during dialysis.Staff reported there was no machine alarm to indicate the needles had become dislodged.The arterial and venous needles were dislodged out of the patient's left upper arteriovenous graft, with the tape remaining attached to the patient's arm and to both needles.Estimated blood loss was 1300ml.911 was called, oxygen provided, and cpr was initiated.Emergency medical services arrived and took over care of the patient.The patient was transported to the hospital and later expired in the emergency room.The hemodialysis machine was pulled from service, where extensive testing was done, and it was held until clinical services received all reports and authorized its return to service.

Manufacturer Narrative

Plant investigation: 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 (hd) patient was scheduled for regular dialysis treatment and hemodialysis was initiated via left upper avg utilizing two #15 gauze needles.Treatment was initiated at approximately 1:09pm for a four hour treatment.At approximately 3:10pm, the patient appeared to be in distress and was placed in trendelenberg position.Blood was noted in the patient's chair and the patient was unresponsive.No reported audible machine alarm was noted.Normal saline was administered via venous line, and normal saline was noted seeping through the arterial line.The tape and 2x2 gauze which was placed over both needle sites was removed.The staff reported the arterial and venous needles were dislodged when they removed the tape, as evident by the saline bolus dispersing onto the patient and her belongings instead of into the vascular system as intended.The patient's access site was not covered during hemodialysis.The staff didn't report the need to manipulate the venous or arterial needles during dialysis; pressures documented on the treatment sheet were stable and within range during dialysis.Staff reported there was no machine alarm to indicate the needles had become dislodged.The arterial and venous needles were dislodged out of the patient's left upper arteriovenous graft, with the tape remaining attached to the patient's arm and to both needles.Estimated blood loss was 1300ml.911 was called, oxygen provided, and cpr was initiated.Emergency medical services arrived and took over care of the patient.The patient was transported to the hospital and later expired in the emergency room.The hemodialysis machine was pulled from service, where extensive testing was done, and it was held until clinical services received all reports and authorized its return to service.

Manufacturer Narrative

Conclusion: the patient blood loss and probable cause of cardiac arrest and subsequent death was a direct result of the patients¿ dialysis arterial and venous access needles becoming dislodged from the patient access site.Neither the arterial nor the venous needles are manufactured by fresenius medical care.There is no documentation or allegation that the 2008t machine or any other fresenius product malfunctioned or did not perform as expected.It is unknown what may have occurred to cause the needles to dislodge two hours after the initiation of hd therapy.

Event Description

Information in the complaint file was reviewed by a post market surveillance clinician.On 01/31/2018, a copy of a voluntary medwatch was received from a hemodialysis (hd) clinic that was previously submitted to the fda for this (b)(6) female end stage renal disease (esrd) patient on in-center hemodialysis (hd) for renal replacement therapy (rrt) to make notification that the patient expired during hd treatment.On (b)(6) 2017, the patient¿s hd therapy was initiated at 13:09 via left upper arteriovenous graft (avg) utilizing two #15 gauge wingeater needles with blood pressure (bp) 132/83, pulse 76, respiration 16 and temperature 98.6 f.Approximately two hours into a scheduled four hour hd treatment at 15:10, the patient was found in distress (unspecified signs/symptoms).During a patient check 30 minutes prior the patient bp was 150/71 with a pulse of 80.The patient was then placed in trendelenburg position and blood was noted under the patient¿s chair.It was reported that no audible machine alarm was heard.The patient became unresponsive and normal saline (ns) was administered via the venous line (unknown volume).The ns was noted to be seeping through the venous line.Ns was then administered through the arterial line, but the ns was seen seeping through that line as well.Tape and 2x2 gauze which had been placed over both needle sites was removed.The needles (arterial and venous) were found to be dislodged out of the patient¿s left upper avg, with the tape remaining attached to the patient¿s arm and to both needles.Nine-one-one (911) was called, oxygen provided, and cardiopulmonary resuscitation (cpr) was initiated.Emergency medical services (ems) arrived and took over care of the patient.It is unknown what further resuscitative efforts were administered to the patient.The patient was transported via ems to the hospital and expired in the emergency room (er).The voluntary medwatch patient codes were listed as blood loss, exsanguination and cardiac arrest.

• 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: 7271709
• MDR Text Key: 100113878
• Report Number: 8030665-2018-00241
• 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: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/12/2018
• 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): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 83