MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA BABYLEO TN500; INCUBATOR, NEONATAL

Catalog Number	2M60000
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Decreased Sensitivity (2534); Device Sensing Problem (2917)
Health Effect - Clinical Code	Hypernatremia (2242)
Date of Event	12/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported by the user: ¿premature baby in the incubator, conspicuous with increasing life-threatening hypernatremia (max.160 mmol/l) and hyperkalemia (max 7.5 mmol/l) despite very high fluid intake up to 220ml/(kg*h).No weight gain, little urine excretion and temperature lability despite the atypically high incubator temperature of 37°c.When viewed together, the only possible cause is very strong transdermal fluid loss.Incubator regulated up from 80% to 99% relative humidity (stated measured values of the incubator in the expected range, but no precipitation on the incubator walls).Therefore the incubator was replaced, which resulted in the child gradually stabilizing.¿.
Additional Manufacturer Narrative
The humidity sensor of both affected devices was made available for the investigation.Furthermore, results of a random test of new sensors and of devices in clinical use as well as the feedback of the sensor supplier regarding cross sensitivities of the humidity sensor towards chemicals were considered.Based on the investigation the reported event could be verified.Increased measurement inaccuracies were detected in the upper humidity measuring range > 70 % rf causing a shortage of humidity of approx.15 ¿ 22 %.In the measurement range below 70 % rf, the affected sensors continued to measure within the specified measurement accuracy.A cross sensitivity of the humidity sensor towards the disinfectant in use was identified to be the root cause of the failure (incidin oxywipe s; not listed in the product specific instructions for use/ifu).An intensive use of the disinfectant was assumed due to the clearly visible abrasive marks of cleaning on the humidity sensor showing an abrasively damaged thermo-coated surface; the foaming behavior could additionally facilitate the penetration of the disinfectant into the humidity sensor.A cross sensitivity was also found in a comparative measurement using an ifu-listed disinfectant based on the same group of active substances, when directly exposed to the disinfectant solution.However, no increase of measurement inaccuracy was found when the listed disinfectant was applied accordingly to the reprocessing procedure in the ifu - in contrast to incidin oxywipe s.Attempts to damage the humidity sensors by direct contact with water/condensate did not result in any damage.The sensors could be used without any restrictions.The determined failure of the affected humidity sensors was confirmed by the sensor supplier; but there was no specific cross-sensitivity known neither to chemicals in general, nor hydrogen peroxide in particular.The sensor manufacturer, however, has not ruled out oxidation damage to contacts and/or polymers when using potentially aggressive chemicals.In case of a faulty humidity sensor an increase of measurement inaccuracy can occur, which can affect the controlling of the humidity including the alarm monitoring of the set climate parameter within the incubator.The present error pattern with significant increases in measurement inaccuracy in the upper measuring range or other total failures of the humidity sensor are not known within the scope of quality monitoring; nor is there any indication of a basic quality problem in the production or in the context of use.It is recommended to follow the instructions for use and to ensure that no liquids or disinfectants get into the electronics of the device in order to avoid technical faults of this kind.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported by the user: ¿premature baby in the incubator, conspicuous with increasing life-threatening hypernatremia (max.160 mmol/l) and hyperkalemia (max 7.5 mmol/l) despite very high fluid intake up to 220ml/(kg*h).No weight gain, little urine excretion and temperature lability despite the atypically high incubator temperature of 37°c.When viewed together, the only possible cause is very strong transdermal fluid loss.Incubator regulated up from 80% to 99% relative humidity (stated measured values of the incubator in the expected range, but no precipitation on the incubator walls).Therefore the incubator was replaced, which resulted in the child gradually stabilizing.¿.

• Brand Name: BABYLEO TN500
• Common Device Name: INCUBATOR, NEONATAL
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11054309
• Report Number: 9611500-2020-00472
• Device Sequence Number: 19495978
• Product Code: FMZ
• UDI-Device Identifier: 04048675436607
• UDI-Public: (01)04048675436607(11)181206(17)200120(93)2M60000-18
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2M60000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 23 WK
• Patient Weight: 227