MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number 03-2722-9

Device Problem Fluid/Blood Leak (1250)

Patient Problems Low Blood Pressure/ Hypotension (1914); Malaise (2359)

Event Date 03/08/2022

Event Type  Injury  

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.The clinical investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A user facility registered nurse (rn) reported that a blood leak occurred with a combiset during the patient¿s hemodialysis (hd) treatment.The patient called the rn over ¿moaning and groaning¿ and stated they were not feeling well.The rn noticed that the machine was turned toward the patient and there was blood leaking from the heparin line of the combiset and onto the floor.The heparin line was not clamped and the cap had come off.The patient¿s blood pressure had dropped to 83/30 from 173/91.Approximately 1.6 l of saline was administered to the patient and the nephrologist was notified of the event.The patient¿s blood was rinsed back and they ended treatment for the day with time remaining.The patient's hemoglobin (hgb) was sampled for testing (results unknown).The rn stated that the nephrologist permitted the patient to leave as long as they were asymptomatic and stable.The patient was instructed to call rn upon their arrival home.The patient¿s standing bp prior to discharge was 113/66.Additional information was requested, however a response was not received.The patient¿s estimated blood loss (ebl) was not provided.There was no patient injury or adverse event as a result of this event.The complaint device was not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Clinical investigation: there is a temporal relationship between hemodialysis utilizing the combi-set bloodlines and the patient event of blood leak with hypotensive event.Additionally, there is a causal relationship between the blood loss requiring the administration of saline and testing of the patient¿s hemoglobin and reported blood leak on the heparin line of the combi-set bloodlines.The reported information from the clinic also stated the clamp on the heparin line was not clamped and the cap was off.The hemodialysis machine operator¿s manual documents if the heparin pump is to be used: connect the heparin syringe, prime the heparin line with heparin, and load heparin syringe into heparin pump.If the heparin pump is not used, clamp the heparin line.It is unknown if the line was clamped at the start of the treatment.The information provided by the clinic referred to the machine being turned toward the patient when the event occurred.It is unknown if this was normal practice, or the patient moved the machine during treatment contributing to the event.Additionally, it was reported that the machine did not alarm; however, it also was reported that no alarm was expected.The machine allows for parameters to be set for the blood pressure alarms.If those parameters are not met, the machine will not alarm.Additionally, depending on the blood leak volume, the machine might not alarm in all blood leak instances.As a result of the reported blood leak, the patient experienced a hypotensive episode due to blood loss and required the administration of 1.6ml of normal saline.Moreover, the patient¿s hemoglobin was sampled for testing.Based on the available information, the reported blood leak on the heparin line of the combi-set bloodlines resulting in blood loss to the patient caused the patient¿s hypotensive event requiring medical intervention.

Event Description

A user facility registered nurse (rn) reported that a blood leak occurred with a combiset during the patient¿s hemodialysis (hd) treatment.The patient called the rn over ¿moaning and groaning¿ and stated they were not feeling well.The rn noticed that the machine was turned toward the patient and there was blood leaking from the heparin line of the combiset and onto the floor.The heparin line was not clamped and the cap had come off.The patient¿s blood pressure had dropped to 83/30 from 173/91.Approximately 1.6 l of saline was administered to the patient and the nephrologist was notified of the event.The patient¿s blood was rinsed back and they ended treatment for the day with time remaining.The patient's hemoglobin (hgb) was sampled for testing (results unknown).The rn stated that the nephrologist permitted the patient to leave as long as they were asymptomatic and stable.The patient was instructed to call rn upon their arrival home.The patient¿s standing bp prior to discharge was 113/66.Additional information was requested, however a response was not received.The patient¿s estimated blood loss (ebl) was not provided.There was no patient injury or adverse event as a result of this event.The complaint device was not available to be returned to the manufacturer for physical evaluation.

Event Description

A user facility registered nurse (rn) reported that a blood leak occurred with a combiset during the patient¿s hemodialysis (hd) treatment.The patient called the rn over ¿moaning and groaning¿ and stated they were not feeling well.The rn noticed that the machine was turned toward the patient and there was blood leaking from the heparin line of the combiset and onto the floor.The heparin line was not clamped and the cap had come off.The patient¿s blood pressure had dropped to 83/30 from 173/91.Approximately 1.6 l of saline was administered to the patient and the nephrologist was notified of the event.The patient¿s blood was rinsed back and they ended treatment for the day with time remaining.The patient's hemoglobin (hgb) was sampled for testing (results unknown).The rn stated that the nephrologist permitted the patient to leave as long as they were asymptomatic and stable.The patient was instructed to call rn upon their arrival home.The patient¿s standing bp prior to discharge was 113/66.Additional information was requested, however a response was not received.The patient¿s estimated blood loss (ebl) was not provided.There was no patient injury or adverse event as a result of this event.The complaint device was not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Correction: h6 (device component code).

• 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.; director, quality systems; 1100 e, military hwy, suite c; pharr TX 78577
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13908559
• MDR Text Key: 291385887
• Report Number: 8030665-2022-00296
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03-2722-9
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 21PR01168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• 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): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic