MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. JAUNDICE METER; NON-INVASIVE TRANSCUTANEOUS BILIRUBINOMETER

Model Number JM103

Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017)

Patient Problem Brain Injury (2219)

Event Date 03/17/2015

Event Type  Injury  

Manufacturer Narrative

There is no indication that the meter did not function as intended.The users in this case misinterpreted the displayed "---" as the meter being defective.After consulting the instructions for use, they found that the displayed "---" meant the reading was out of range.Draeger has initiated a field action.

Event Description

Due to a processing error, this mdr is being submitted late.The customer reported that during use on a patient with a family history of jaundice and yellowing of the skin noted by patients mother, due to a user misunderstanding of an out of range reading ("---") on the jaundice meter, there was a delay in treatment (phototherapy, anticonvulsant drugs, and blood transfusion).It was reported that the patient suffered brain damage.

Manufacturer Narrative

The following information was provided by agency for health care (ivo) in sweden which is the government agency responsible for supervising healthcare and social care.The following is their internal investigation and risk prevention which was provided to us.The patient involved was born march 17, 2015 [prematurely].The mother had informed the staff that her other children also needed phototherapy at birth.When the patient was about 13 hours old, attempts were made to control the transcutaneous bilirubin (device for measuring the skin of bilirubin), because the mother understood the patient's yellowish skin and expressed concern over this.In the opinion of the patient's parent¿s, the staff informed them that the measuring device was defective and therefore changed to another.After a new attempt to measure was made, the parents were informed about the measurement results were reliable and that they should wait until the next day.The mother expressed concern and attempts to measure the bilirubin level was not done.On the morning of the following day the staff saw the patient's skin was yellowish.In the new measurement with bilirubin appeared only dashes in the display.According to the product manual, this means that the bilirubin level is outside the measuring range, which the staff did not know.The attending doctor prescribed blood tests which showed significantly elevated bilirubin in serum (514 micromolar at 30 hours of age).At noon march 18 th, the patient was transferred to the neonatal unit, and phototherapy began.Repeated tests showed gradually decreasing bilirubin.Later in the day the patient received additional symptoms including occasional pauses in breathing, which was interpreted as called mammalian diving reflex.Respiratory challenges increased in frequency during the night and the patient also suffered from seizures, prompting treatment with anticonvulsant drugs and monitoring with aeeg (continuous monitoring of brain electrical activity).Because of pathological aeeg pattern and apnea, the attending physician was contacted several times.The stand-in dr.Was contacted after which treatment with immunoglobulin began.The following day, march 19th showed blood rising bilirubin and exchange transfusion was performed.Continued sampling showed declining values and the seizures stopped.Later showed signs of brain damage called mri kernicterus.Follow-up of patient was done through, among other things, a pediatric neurologist.The investigation determined patient premature labor and violations of risk prevention measures.The following risk prevention measures have been implemented at the customer site: training of staff who come into contact with newborns in the maternity ward regarding the management and complications from high bilirubin levels.Internal investigation is being done in their laboratory to determine the handling of test results with high bilirubin levels.Neonatal operations has prepared a memorandum regarding indication for blood replacement.All staff in the labor department has been informed about the incident and received training in the field.This included a review of equipment and manuals introduced the checklist for the introduction of new employees.Based on the above information, draeger has concluded the following.Although the customer reported they did not understand the symbol for the out of range reading, there were multiple errors of protocol at the hospital which contributed to the serious injury and not the misinterpretation of the reading on the jm-103.Baby was born premature, which increases the likelihood of jaundice.There was no numeric reading provided on the jm-103 to make a determination regarding treatment of jaundice.The mother reported early on to staff that there is a family history of jaundice, which increases the likelihood of jaundice.The mother reported on multiple occasions that the baby was visibly yellow which indicates jaundice.Note: the jaundice meter measures the yellowness of skin tissue.Therefore there was no need to screen further.The clinician should have performed a blood test (laboratory measurements) immediately which is standard clinical practice and noted in the ifu.The mother escalated her concerns multiple times to the staff of the baby¿s yellow skin.It was reported the staff did not know how to read the device.The hospital waited until the next day to do a blood test, even after the mother brought concern multiple times to the staff including family history of jaundice.In addition the jm-103 ifu states: the device is not intended as a standalone screening device for diagnosis of hyperbilirubinemia.It is to be used as a screening device in conjunction with other clinical signs and laboratory measurements.This is the only injury reported for the jm-103 out of approximately 8000 units sold world-wide over the last decade.In addition the does not indicate a number nor a parameter value, which would be needed to determine appropriate treatment of jaundice.The ifu also identifies in 2 sections the meaning of including contacting the physician and that the value is outside of the range.

Event Description

The customer reported that during use on a patient with a family history of jaundice and yellowing of the skin noted by patients mother, due to a user misunderstanding of an out of range reading on the jaundice meter, there was a delay in treatment (phototherapy, anticonvulsant drugs, and blood transfusion).It was reported that the patient suffered brain damage.

• Brand Name: JAUNDICE METER
• Type of Device: NON-INVASIVE TRANSCUTANEOUS BILIRUBINOMETER
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA 18969
• MDR Report Key: 7441559
• MDR Text Key: 105873925
• Report Number: 2510954-2018-00002
• Device Sequence Number: 1
• Product Code: MQM
• Combination Product (y/n): N
• PMA/PMN Number: K042522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Model Number: JM103
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 05/18/2017
• Supplement Dates FDA Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1220063-04/17/2018-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Disability